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Original Contribution |

Cognitive Behavior Therapy for Generalized Anxiety Disorder Among Older Adults in Primary Care:  A Randomized Clinical Trial FREE

Melinda A. Stanley, PhD; Nancy L. Wilson, MS, MSW; Diane M. Novy, PhD; Howard M. Rhoades, PhD; Paula D. Wagener, BA; Anthony J. Greisinger, PhD; Jeffrey A. Cully, PhD; Mark E. Kunik, MD, MPH
[+] Author Affiliations

Author Affiliations: Houston Center for Quality of Care & Utilization Studies (Drs Stanley, Cully, and Kunik and Mss Wilson and Wagener); Baylor College of Medicine (Drs Stanley, Cully, and Kunik and Ms Wilson); The University of Texas M. D. Anderson Cancer Center (Dr Novy); The University of Texas Health Science Center at Houston (Dr Rhoades); Kelsey Research Foundation (Dr Greisinger); Michael E. DeBakey Veterans Affairs Medical Center (Drs Cully and Kunik); and VA South Central Mental Illness, Research, Education and Clinical Center (Drs Cully and Kunik), Houston, Texas.


JAMA. 2009;301(14):1460-1467. doi:10.1001/jama.2009.458.
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Published online

Context Cognitive behavior therapy (CBT) can be effective for late-life generalized anxiety disorder (GAD), but only pilot studies have been conducted in primary care, where older adults most often seek treatment.

Objective To examine effects of CBT relative to enhanced usual care (EUC) in older adults with GAD in primary care.

Design, Setting, and Participants Randomized clinical trial recruiting 134 older adults (mean age, 66.9 years) from March 2004 to August 2006 in 2 primary care settings. Treatment was provided for 3 months; assessments were conducted at baseline, posttreatment (3 months), and over 12 months of follow-up, with assessments at 6, 9, 12, and 15 months.

Intervention Cognitive behavior therapy (n = 70) conducted in the primary care clinics. Treatment included education and awareness, motivational interviewing, relaxation training, cognitive therapy, exposure, problem-solving skills training, and behavioral sleep management. Patients assigned to receive EUC (n = 64) received biweekly telephone calls to ensure patient safety and provide minimal support.

Main Outcome Measures Primary outcomes included worry severity (Penn State Worry Questionnaire) and GAD severity (GAD Severity Scale). Secondary outcomes included anxiety ratings (Hamilton Anxiety Rating Scale, Beck Anxiety Inventory), coexistent depressive symptoms (Beck Depression Inventory II), and physical/mental health quality of life (12-Item Short Form Health Survey).

Results Cognitive behavior therapy compared with EUC significantly improved worry severity (45.6 [95% confidence interval {CI}, 43.4-47.8] vs 54.4 [95% CI, 51.4-57.3], respectively; P < .001), depressive symptoms (10.2 [95% CI, 8.5-11.9] vs 12.8 [95% CI, 10.5-15.1], P = .02), and general mental health (49.6 [95% CI, 47.4-51.8] vs 45.3 [95% CI, 42.6-47.9], P = .008). There was no difference in GAD severity in patients receiving CBT vs those receiving EUC (8.6 [95% CI, 7.7-9.5] vs 9.9 [95% CI, 8.7-11.1], P = .19). In intention-to-treat analyses, response rates defined according to worry severity were higher following CBT compared with EUC at 3 months (40.0% [28/70] vs 21.9% [14/64], P = .02).

Conclusions Compared with EUC, CBT resulted in greater improvement in worry severity, depressive symptoms, and general mental health for older patients with GAD in primary care. However, a measure of GAD severity did not indicate greater improvement with CBT.

Trial Registration clinicaltrials.gov Identifier: NCT00308724

Figures in this Article

Generalized anxiety disorder (GAD) is common in late life, with prevalence up to 7.3%1 in the community and 11.2% in primary care.2 Late-life anxiety predicts increased physical disability,3 memory difficulties,4 decreased quality of life,5 increased service utilization,6 and mortality.7 Coexistent depressive disorders are common.8 Generalized anxiety disorder often precedes depression, suggesting it as a risk factor.9

Late-life anxiety is usually treated with medication. Benzodiazepines and antidepressants are effective,10 but associated risks (eg, falls, hip fractures, memory problems) and patient fears of adverse effects limit their usefulness.11 Older patients also prefer psychosocial interventions.12

Initial outcome studies of cognitive behavior therapy (CBT) for late-life GAD focused on group-based interventions in academic settings.13,14 Effects were moderate relative to wait-list and minimal-contact controls (d = 0.71-0.75) and small relative to alternative psychotherapy (d = 0.20-0.29).14 Treatment response rates were low (28%-45%)14 but increased over follow-up. Individually administered CBT produced larger effect sizes (0.78-1.3) and improved response, though sample sizes in these trials were smaller.15,16

Generalizability of these findings is limited because participants were mostly white, well educated, and healthy. Results also may not be relevant for patients in primary care, where older adults typically present for treatment. Cognitive behavior therapy within a collaborative-care framework in primary care has been effective for younger patients with panic disorder, GAD, or both17 as well as for older patients with depression,18 although effect sizes and treatment-response rates were lower than in academic clinical trials. The late-life anxiety literature lags behind these other areas, with only 2 pilot studies addressing treatment in primary care.19,20 These studies suggest benefits for CBT, but sample sizes were small (n = 12 and 31), and conclusions were limited.

We report results of the first randomized clinical trial of CBT for late-life GAD in primary care. We hypothesized that CBT would improve outcomes relative to enhanced usual care (EUC) at 3 months posttreatment and that gains would be maintained or enhanced over long-term follow-up (3-15 months).

The study was approved by the institutional review boards of The University of Texas Health Science Center at Houston and Baylor College of Medicine. Participants provided written informed consent for all procedures and received compensation of $20 for each completed assessment.

Patient Population

From March 2004 to August 2006, we recruited participants 60 years or older. Total recruitment duration, however, was only 26 months because of two 2-month interruptions. In August 2004, the primary academic affiliation of the project changed from The University of Texas Health Science Center at Houston to Baylor College of Medicine, and recruitment resumed in October 2004; recruitment was discontinued from September 2005 through October 2005 because of the significant impact of hurricanes Katrina and Rita in the Houston area.

Most recruitment occurred through the Kelsey-Seybold Clinic, a large, multispecialty medical organization in the greater Houston, Texas, area. For 6 months, participants were also recruited from the Baylor College of Medicine Family Medicine Clinic (Houston, Texas). Recruitment occurred through patient self-referral and physician referral. Educational brochures were placed in waiting and examination rooms, health information centers, and patient newsletters. Informational letters also were mailed to randomly selected patients in the appropriate age range. Physician referrals were encouraged by presentations at staff meetings, electronic communications with clinicians, and individual networking.

Referred patients were asked 2 anxiety screening questions from the Primary Care Evaluation of Mental Disorders.21 Individuals responding affirmatively were scheduled to review informed consent, collect demographic data, and receive the Mini-Mental State Examination22 and the Structured Diagnostic Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition).23 All interviewers administering the structured interview (psychology staff, graduate students, interns, and fellows) received extensive training. In addition, all interviews were audiotaped, and 20% were rated by a second clinician. Adequate diagnostic agreement was suggested for GAD (κ = 0.64), depression (major depression and dysthymia, κ = 0.75), social phobia (κ = 0.81), and specific phobia κ = 0.64). Patients with a principal or coprincipal diagnosis of GAD according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) were included. Patients with Mini-Mental State Examination scores less than 24 were excluded, as were patients with active substance abuse, psychosis, or bipolar disorder. Race and ethnicity were self-identified by the patient according to categories provided by research staff. These data were collected to facilitate conclusions about generalizability of the data.

Measures and Data Collection

Primary Outcomes. Primary outcomes assessed worry and GAD severity. Worry severity was measured with the Penn State Worry Questionnaire (PSWQ),24 a 16-item, self-report scale. GAD severity was evaluated with the Generalized Anxiety Disorder Severity Scale (GADSS),25 a 6-item, clinician-rated scale. The PSWQ has good psychometrics among older adults26 and has been a primary outcome measure in psychosocial trials of late-life GAD.27,28 No minimal clinically significant difference has been established for the PSWQ, but prior positive clinical trials have demonstrated a change of 8.5 points on the measure following CBT.28,29 This value was used here to indicate meaningful change. The GADSS also has adequate psychometric support for older adults,29 although no data from this measure have been reported from clinical trials of GAD. Here, a change of 2.0 points on the GADSS was considered meaningful, given that a difference of 2 points significantly differentiated patients referred to a clinical trial who did and did not meet criteria for GAD.29

Secondary Outcomes. Secondary outcomes assessed coexistent anxiety and depressive symptoms as well as physical/mental health status. Anxiety severity was measured with the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A).30 The SIGH-A has adequate psychometric support among older adults.31 Severity of depressive symptoms was measured with the Beck Depression Inventory II (BDI-II).32 The BDI-II has been used with community samples of older adults33 and older adults with anxiety.20 Health quality of life was measured with the Medical Outcomes Study 12-item Short Form Health Survey, which yields 2 summary scores developed from the original measure,34 the mental component score (MCS) and the physical component score.35 Reliability and validity of the short form survey have been established in older adults.36

Other Treatments. Medication use was assessed with patient self-report questions about the type and frequency of medications used over the prior 3 months.37,38 Medications classified as antianxiety (benzodiazepine, buspirone, or other) or antidepressant (selective serotonin reuptake inhibitor, nonselective serotonin reuptake inhibitor, tricyclic antidepressant, or other) were considered. Patients also were asked to report the number of outpatient medical and mental health visits and to indicate whether they had spoken with their primary care physician (PCP) about emotional issues or received a mental health referral over the past 3 months.

Data Collection. All outcome measures were administered via telephone by a master’s- or postdoctoral-level independent evaluator unaware of treatment assignment. (Given the nature of the intervention and control, patients and therapists were not blinded to group assignment.) Independent evaluators readministered outcome evaluations at 3 months posttreatment and at 3-month intervals over a 12-month follow-up period. The third author (D.M.N.) held regular calibration meetings with independent evaluators. All assessment sessions were audiotaped, and a random 10% were reviewed by a different independent rater. Interrater agreement on the GADSS29 and the SIGH-A31 was excellent (intraclass correlation coefficient = 0.99 for GADSS; intraclass correlation coefficient = 0.95 for SIGH-A). Psychometric properties for telephone-based assessment instruments were comparable to in-person versions.39

Intervention

Five experienced therapists provided CBT in up to 10 individual sessions over 12 weeks. Therapists were 3 master’s-level therapists with at least 2 years of CBT experience, 1 predoctoral intern with more than 3 years' experience in CBT for anxiety, and 1 post−bachelor’s-level therapist (P.D.W.) with 5 years' experience in CBT for late-life anxiety.

Therapist training involved treatment of 2 nonstudy patients, with competence and adherence ratings of at least 6 (on a 0-8 scale). Cognitive behavior therapy included education and awareness, motivational interviewing, relaxation training, cognitive therapy, exposure, problem-solving skills training, and behavioral sleep management.40 Brief telephone booster sessions were offered at 4, 7, 10, and 13 months. Sessions were audiotaped, and 20% were rated by 2 independent treatment-integrity experts, Hopko and Diefenbach, who coauthored the treatment manual40 on which the CBT used in this study was based. Neither participated in the study in other ways. Ratings suggested excellent adherence (7.7 [SD, 0.55]; range, 0-8) and competence (7.3 [SD, 0.67]; range, 0-8).

Patients randomized to receive EUC were telephoned biweekly during the first 3 months of the study by the same therapists to provide support and ensure patient safety. Calls lasted approximately 15 minutes. Therapists reminded patients to call project staff if symptoms worsened and suggested contacting their PCPs for medical problems. A supervisor (M.A.S., N.L.W., M.E.K.) and the patient's PCP were notified of patients needing immediate psychiatric care. All calls were audiotaped, and 20% (n = 93) were reviewed by the first author (M.A.S.). Only 3 protocol deviations were identified.

Patients randomized to receive CBT completed a mean of 7.4 (SD, 1.91) sessions in the primary care clinic. Patients randomized to receive EUC received a mean of 4.3 (SD, 1.26) telephone check-ins. After the first session in each condition, patient expectancy was assessed with a single item asking patients to rate the amount of improvement they expected (0% = none, 100% = complete improvement).41 Communication with the PCP occurred via notes filed in the research section of the written medical record. Initial notes indicated diagnoses assigned and inclusion/exclusion status. For excluded patients, potential referrals were provided to the PCP and the patient. For included patients, notes encouraged care as usual and indicated whether patients had received a CBT session or an EUC contact.

Randomization

Patients were initially randomized according to a 1:1 ratio within blocks of 10 to receive CBT or EUC. More patients were randomized to CBT (n = 70) than to EUC (n = 64). Inspection of data at study midpoint (50% recruitment completed) revealed a disproportionate random assignment of Hispanic patients to receive EUC. A stratified randomization schedule was then instituted for Hispanic patients, with 80% assignment to CBT, to ensure equivalence across groups. Non-Hispanic patients were maintained on the original 1:1 randomization schedule. The randomization scheme was generated by the study statistician (H.M.R.) using a random-number generator, and assignments were placed in numbered, sealed envelopes. At completion of baseline assessment, a study research assistant opened the next envelope in sequence and assigned the participant to a treatment condition.

Data Analysis

Before conducting outcome analyses, we compared patients in the CBT and EUC subgroups on pretreatment demographic variables, clinical characteristics, and medication use, using χ2 analyses and t tests (Table 1). Primary analyses then examined posttreatment outcomes by comparing group differences at 3 months, using a between-groups analysis of covariance, with pretreatment assessment as the covariate. Initial analyses were by intention-to-treat (ITT), using the Proc MI and MIANALYZE multiple imputation procedures in SAS version 9.2 (SAS Institute Inc, Cary, North Carolina) to address missing data. Another set of analyses repeated these comparisons only with observed data, using random regression methods (ie, completer analysis using the SAS Proc Mixed procedure). Secondary analyses examined long-term outcomes with a repeated-measures analysis of covariance procedure (SAS Proc Mixed), again with the pretreatment assessment as the covariate. To control for multiple comparisons within clusters of outcomes (primary outcomes, coexistent anxiety-depression, health quality of life), each of which included 2 variables, critical α was set at P<.025. All significance testing was 2-sided.

Table Graphic Jump LocationTable 1. Baseline Sociodemographic and Clinical Characteristics by Intervention Status

Because 3 couples participated in the study (with both partners randomized to receive the same intervention; 2 couples to receive CBT, 1 couple to receive EUC), all analyses were rerun with one partner from each couple randomly removed to assess the possible influence of correlated data. These analyses did not result in different findings and therefore are omitted. Changes in the use of antidepressant and antianxiety medications during the trial were examined with χ2 analyses, and exploratory analyses examined the role of expectancies in predicting outcome (0% = none, 100% = complete improvement).

Treatment response was defined by meaningful change in scores on the PSWQ and GADSS (8.5 for the PSWQ, 2.0 for the GADSS; see “Primary Outcomes”). The proportions of patients classified as treatment responders according to these cutoffs were determined at 3 and 15 months. Group differences in the ITT and completer samples were tested using χ2 analyses. For ITT analyses, patients with missing data were classified as nonresponders.

Power calculations were based on the PSWQ, which is a primary outcome in CBT trials of late-life GAD. The median SD across these trials is 10.1. This value was considered in combination with an expected moderate effect size (d = 0.60; minimal detectable difference, 6.2), desired 80% power, and α = .025. Given these parameters and a potential 30% attrition, our goal was to include 150 participants so that 53 per group would be available for analysis. The included sample (n = 148) was 99% of this target. The randomized sample (n = 70 CBT, n = 64 EUC) and the completer sample (n = 115) both exceeded the required 53 per group.

Sample Selection and Attrition

A total of 968 potential participants were referred (75% self-referred), and 381 provided consent (Figure). Of these, 68 (18%) dropped out or were excluded before diagnostic evaluation because of negative responses to screening questions on the Primary Care Evaluation of Mental Disorders (n = 14), lack of interest (n = 35), or logistic problems (n = 19). Of the remaining 313 patients, 154 were excluded and 11 were included as nonstudy clinical training cases but excluded from analyses. A total of 148 patients met inclusion criteria (95% self-referred); of these, 14 (9%) dropped out before randomization, leaving 134 patients with principal (n = 86) or coprincipal (n = 48) GAD for randomization.

Place holder to copy figure label and caption
Figure. Flow of Participants Through Each Phase of the Study
Graphic Jump Location

Patients who dropped out did not participate in subsequent assessments; those who could not be contacted at one assessment were allowed to participate in subsequent assessments.

Relative to patients who provided consent but were not randomized (n = 247), randomized patients (n = 134) were younger (mean age, 66.9 years [95% confidence interval {CI}, 65.9-67.9] vs 69.0 years [95% CI, 68.2-69.9]; P = .002), more educated (mean years of education, 15.9 [95% CI, 15.4-16.4] vs 15.1 [95% CI, 14.7-15.5]; P = .02), and more likely to be women (75% [105/134] vs 68% [168/246], P = .04). Randomized patients also had higher baseline PSWQ scores than other patients for whom baseline severity data were available (n = 167) (57.2 [95% CI, 55.4-59.0] vs 46.5 [95% CI, 44.6-48.3], P < .001).

Dropout during active treatment (0-3 months) was significantly lower for patients receiving CBT than for those receiving EUC (5.9% [4/70] vs 21.9% [14/64], P = .006), primarily because of self-reported dissatisfaction with random assignment (CBT, n = 0; EUC, n = 9). Attrition over long-term follow-up (3-15 months) was comparable for CBT and EUC (CBT, 12.9% [9/70]; EUC, 9.4% [6/64]; P = .52). Total attrition over 15 months was 24.6% (n = 33) and did not differ significantly between groups (CBT, 18.6% [13/70]; EUC, 31.3% [20/64]; P = .09). Reasons for dropout are described in the Figure. Analyses of variance revealed no group × drop status differences on any baseline measure.

Sample characteristics are included in Table 1. Patients in the CBT and EUC groups differed with regard to baseline PSWQ scores. Analyses of primary outcomes (assessed using the PSWQ and GADSS) included baseline PSWQ as a covariate.

Posttreatment Outcomes (0-3 months)

Mean observed scores at 0 and 3 months are presented in Table 2. Imputed means and CIs were not statistically or substantially different from observed values.

Table Graphic Jump LocationTable 2. Mean (SD) Scores on Outcomes Measures Across Time for Patients Receiving CBT or EUCa

Primary Outcomes. Intention-to-treat analyses indicated significantly greater improvement on the PSWQ in patients completing CBT than in those completing EUC (45.6 [95% CI, 43.4-47.8] vs 54.4 [95% CI, 51.4-57.3], P < .001) (Table 2). Mean change was 7.7 points in the CBT group and 3.2 points in the EUC group. Group differences on the GADSS were not significant, with a mean change of 2.8 points in the CBT group and 1.4 points in the EUC group. Completer analyses resulted in the same pattern of statistical results.

Secondary Outcomes. Intention-to-treat analyses suggested significantly greater improvement on the BDI-II in patients completing CBT than in those completing EUC (10.2 [95% CI, 8.5-11.9] vs 12.8 [95% CI, 10.5-15.1], P = .02); this was true for the MCS as well (49.6 [95% CI, 47.4-51.8] vs 45.3 [95% CI, 42.6-47.9], P = .008) (Table 2). Changes on the SIGH-A and PCS were not significantly different between groups. Completer analyses suggested similar patterns of results.

Other Treatments. Patients who completed CBT and EUC did not differentially add or increase dosages of antianxiety medication during active treatment (4.6% [3/65] vs 2.0% [1/50], P = .45). Rates of discontinuation or reduced dosages of these medications also were equivalent across groups (7.7% [5/65] vs 4.0% [2/50], P = .41). Similarly, rates of increased doses or new antidepressant medication (12.3% [8/65] vs 6.0% [3/50], P = .25) and decreased doses or medication discontinuation (7.7% [5/65] vs 2.0% [1/50], P = .17) were similar in patients completing CBT and EUC.

Patients in the CBT and EUC groups also had equivalent numbers of outpatient medical visits (2.7 [95% CI, 2.1-3.2] vs 2.3 [95% CI, 1.6-3.0], P = .85) and similarly infrequent mental health visits (0.5 [95% CI, 0.0-1.0] vs 0.7 [95% CI, 0.2-1.3], P = .82). Very few patients in either group received a mental health referral (7.7% [5/65] vs 8.0% [4/50], P = .95) or spoke with their PCP about emotional problems (20.0% [13/65] vs 18.0% [9/50], P = .82).

Long-term Outcomes (3-15 Months)

Primary Outcomes. Analyses indicated continued improvement in PSWQ scores over long-term follow-up for patients in both groups (time effect [Table 2]). Covariate-adjusted posttreatment group differences also continued over the long term for the PSWQ (group effect [Table 2]). These differences suggest that no additional differential group response was present and that the initial treatment effectiveness at the end of active treatment was maintained throughout the 12-month follow-up period.

Secondary Outcomes. Posttreatment effects on the BDI-II and the MCS were maintained over the subsequent 12 months (group effects [Table 2]). Patients who completed CBT and EUC did not increase doses or add antianxiety medication at different rates over 3 to 15 months (12.5% [8/64] vs 16.7% [8/48], P = .53). Rates of decreasing doses or discontinuation of these medications also were equivalent (14.1% [9/64] vs 16.7% [8/48], P = .70). Antidepressant medications also were added or doses increased (18.8% [12/64] vs 14.6% [7/48], P = .56) and discontinued or doses reduced (18.8% [12/64] vs 12.5% [6/48], P = .37) at similar rates over long-term follow-up.

Treatment Response Rates and Expectancies

Mean percentages of treatment responders according to ITT analyses of meaningful change scores (8.5 for the PSWQ, 2.0 for the GADSS) are reported in Table 3. Treatment response rates according to the PSWQ were higher at 3 months in patients completing CBT than in those completing EUC. Completer analyses revealed no group differences at 3 or 15 months.

Table Graphic Jump LocationTable 3. Mean Percentages of Patients Classified as Treatment Responders According to Meaningful Change Scores on the PSWQ (8.5) and the GADSS (2.0) at 3 and 15 Months

Average treatment expectancies were significantly higher for patients who completed CBT than for those who completed EUC (78% [95% CI, 74%-83%] expected improvement vs 66% [95% CI, 58%-74%], P = .007). When expectancies were added to the previously tested models as covariates, effects for treatment remained significant for the PSWQ (P < .001), but group differences on the BDI-II (P = .05) and the MCS (P = .04) only approached significance.

This study is the first to suggest that CBT can be useful for managing worry and associated symptoms among older patients in primary care. Patients receiving CBT had greater improvements in worry severity, depressive symptoms, and general mental health than those receiving EUC. Mean change in worry severity over time was slightly lower than in other clinical trials of CBT for late-life anxiety.28,29 Mean change in GAD severity following CBT was meaningful but not significantly different than that following EUC. Effect sizes for symptom improvement were comparable to or greater than those in primary care studies of younger adults with GAD or panic disorder17,42 and older adults with depression.18

Positive findings in this trial are particularly notable, given that other primary care studies involve full collaborative-care models incorporating medication as well as cognitive behavioral treatments. In this study, comparable effects were found with CBT alone, as in a subset of data from the Improving Mood Promoting Access to Collaborative Care Treatment (IMPACT) trial.43 The findings of the current study also are the first to demonstrate positive effects of treatment for GAD in primary care. A subset of data from a study by Rollman et al17 showed no significant benefits of collaborative care for young patients with GAD only (without coexistent panic disorder), relative to usual care. In the current trial, posttreatment symptom improvements were maintained or improved over 1 year of follow-up.

Treatment response rates based on worry severity as measured using the PSWQ were higher at 3 months in patients receiving CBT than in those receiving EUC, but treatment-group differences were not maintained at 15 months. Patterns of response suggest maintenance of gains with CBT but a slight increase in treatment response with EUC. Increased booster sessions over the long term might be beneficial for continued improvement following CBT.

The GADSS failed to demonstrate treatment effects, suggesting a potential limitation of this scale as a measure for late-life GAD. Exploratory analysis also suggested a meaningful role of expectancies on secondary outcomes. Future work is needed to more fully examine possible moderator and mediator variables in response to CBT.

Significant strengths of this study include careful selection and diagnosis of patients, breadth of outcome assessment, excellent treatment integrity, low attrition (6%) in the CBT group, and significant improvement in primary as well as secondary outcomes. Certain design features, however, limit translational value and potential sustainability for primary care settings. First, the sample was not representative of older patients in primary care with regard to age, sex, and education. Moreover, randomized patients were younger, more highly educated, and more likely to be women than nonrandomized patients. These characteristics may reflect both the recruitment setting (insurance-based care) and the self-referred nature of most participants. Primary care patients with anxiety who are recruited through physician referral using prompts from electronic medical records are more diverse demographically and have higher levels of anxiety.44

Second, clinicians providing CBT and EUC had significant expertise in late-life anxiety and CBT. Treatment with CBT was delivered during weekly in-person sessions of approximately 1 hour. This type of service is rarely available in primary care. Also, the telephone contacts in the EUC condition did not completely control for the increased attention for the patients receiving CBT. Communication with PCPs was limited to written notes in a research section of the medical record. No electronic medical record was available to facilitate integration of treatment with ongoing care.

Cognitive behavior therapy is useful for older adults with GAD in primary care. This study paves the way for future research to test sustainable models of care in more demographically heterogeneous groups. In future studies, it will be important to examine the impact of treatment delivered by clinicians without specialized CBT expertise. Improved integration with ongoing care would be facilitated through use of an electronic medical record to identify patients and communicate with clinicians,39 and collaborative models of care that incorporate both CBT and medication need to be tested.

Corresponding Author: Melinda A. Stanley, PhD, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston Center for Quality of Care & Utilization Studies (MEDVAMC 152), 2002 Holcombe Blvd, Houston, TX 77030 (mstanley@bcm.tmc.edu).

Author Contributions: Dr Stanley had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Stanley, Wilson, Novy, Kunik.

Acquisition of data: Novy, Wagener, Greisinger, Cully.

Analysis and interpretation of data: Stanley, Rhoades, Cully, Kunik.

Drafting of the manuscript: Stanley, Novy, Rhoades, Wagener, Cully, Kunik.

Critical revision of the manuscript for important intellectual content: Stanley, Wilson, Rhoades, Greisinger, Cully, Kunik.

Statistical analysis: Novy, Rhoades.

Obtained funding: Stanley, Novy, Kunik.

Administrative, technical, or material support: Wilson, Wagener, Greisinger, Cully, Kunik.

Study supervision: Stanley, Wilson.

Financial Disclosures: None reported.

Funding/Support: This research was supported by a grant from the National Institute of Mental Health (NIMH) (R01-MH53932) to Dr Stanley and by the Houston VA Health Services Research and Development Center of Excellence (Houston Center for Quality of Care and Utilization Studies [HFP90-020]).

Role of the Sponsor: The NIMH had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIMH, the National Institutes of Health, the Veterans Administration, or Baylor College of Medicine.

Additional Contributions: We thank Gretchen Diefenbach, PhD (Hartford Institute of Living), and Derek Hopko, PhD (University of Tennessee–Knoxville), for providing ratings of treatment integrity and Bruce Rollman, MD (University of Pittsburgh), and Patricia Areán, PhD (University of California–San Francisco), for serving as consultants for this study. These individuals received financial compensation from the grants for their contributions.

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Brenes GA, Kritchevsky SB, Mehta KM,  et al.  Scared to death: results from the Health, Aging, and Body Composition study.  Am J Geriatr Psychiatry. 2007;15(3):262-265
PubMed   |  Link to Article
Beekman AT, de Beurs E, van Balkom AJ, Deeg DJ, van Dyck R, van Tilburg W. Anxiety and depression in later life: co-occurrence and communality of risk factors.  Am J Psychiatry. 2000;157(1):89-95
PubMed
Schoevers RA, Deeg DJ, van Tilburg W, Beekman AT. Depression and generalized anxiety disorder: co-occurrence and longitudinal patterns in elderly patients.  Am J Geriatr Psychiatry. 2005;13(1):31-39
PubMed
Pinquart M, Duberstein PR. Treatment of anxiety disorders in older adults: a meta-analytic comparison of behavioral and pharmacological interventions.  Am J Geriatr Psychiatry. 2007;15(8):639-651
PubMed   |  Link to Article
Allain H, Bentué-Ferrer D, Polard E, Akwa Y, Patat A. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review.  Drugs Aging. 2005;22(9):749-765
PubMed   |  Link to Article
Gum AM, Arean PA, Hunkeler E,  et al.  Depression treatment preferences in older primary care patients.  Gerontologist. 2006;46(1):14-22
PubMed   |  Link to Article
Hendriks GJ, Oude Voshaar RC, Keijsers GP, Hoogduin CA, van Balkom AJ. Cognitive-behavioural therapy for late-life anxiety disorders: a systematic review and meta-analysis.  Acta Psychiatr Scand. 2008;117(6):403-411
PubMed   |  Link to Article
Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders.  Psychiatr Clin North Am. 2005;28(4):871-896, ix
PubMed   |  Link to Article
Mohlman J, Gorenstein EE, Kleber M, de Jesus M, Gorman JM, Papp LA. Standard and enhanced cognitive-behavior therapy for late-life generalized anxiety disorder: two pilot investigations.  Am J Geriatr Psychiatry. 2003;11(1):24-32
PubMed
Mohlman J, Gorman JM. The role of executive functioning in CBT: a pilot study with anxious older adults.  Behav Res Ther. 2005;43(4):447-465
PubMed   |  Link to Article
Rollman BL, Belnap BH, Mazumdar S,  et al.  A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care.  Arch Gen Psychiatry. 2005;62(12):1332-1341
PubMed   |  Link to Article
Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes.  Arch Intern Med. 2006;166(21):2314-2321
PubMed   |  Link to Article
Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings.  Am J Geriatr Psychiatry. 2003;11(1):92-96
PubMed
Wetherell JL, Ayers CR, Sorrell JT,  et al.  Modular psychotherapy for anxiety in older primary care patients.  Am J Geriatr PsychiatryIn press
PubMed
Spitzer RL, Williams JB, Kroenke K,  et al.  Utility of a new procedure for diagnosing mental disorders in primary care: the PRIME-MD 1000 study.  JAMA. 1994;272(22):1749-1756
PubMed   |  Link to Article
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician.  J Psychiatr Res. 1975;12(3):189-198
PubMed   |  Link to Article
First MB, Spitzer RL, Miriam G, Williams JBW. Structured Clinical Interview for DSM-IV Axis I Disorders, Research Version, Patient Edition With Psychotic.  New York, NY: Biometrics Research, New York State Psychiatric Institute; 1997
Meyer T, Miller ML, Metzger R, Borkovec TD. Development and validation of the Penn State Worry Scale.  Behav Res Ther. 1990;28(6):487-495
PubMed   |  Link to Article
Shear K, Belnap BH, Mazumdar S, Houck P, Rollman BL. Generalized Anxiety Disorder Severity Scale (GADSS): a preliminary validation study.  Depress Anxiety. 2006;23(2):77-82
PubMed   |  Link to Article
Hopko DR, Stanley MA, Reas DL,  et al.  Assessing worry in older adults: confirmatory factor analysis of the Penn State Worry Questionnaire and psychometric properties of an abbreviated model.  Psychol Assess. 2003;15(2):173-183
PubMed   |  Link to Article
Stanley MA, Beck JG, Novy DM,  et al.  Cognitive-behavioral treatment of late-life generalized anxiety disorder.  J Consult Clin Psychol. 2003;71(2):309-319
PubMed   |  Link to Article
Wetherell JL, Gatz M, Craske MG. Treatment of generalized anxiety disorder in older adults.  J Consult Clin Psychol. 2003;71(1):31-40
PubMed   |  Link to Article
Weiss BJ, Calleo J, Rhoades H,  et al.  The utility of the Generalized Anxiety Disorder Severity Scale (GADSS) with older adults in primary care.  Depress Anxiety. 2009;26(1):E10-E15
PubMed   |  Link to Article
Shear MK, Vander Bilt J, Rucci P,  et al.  Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A).  Depress Anxiety. 2001;13(4):166-178
PubMed   |  Link to Article
Skopp NA, Novy D, Kunik ME,  et al.  Investigation of cognitive behavior therapy.  Am J Geriatr Psychiatry. 2006;14(3):292
PubMed   |  Link to Article
Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory. 2nd ed. San Antonio, TX: Psychological Corp; 1996
Segal DL, Coolidge FL, Cahill BS, O’Riley AA. Psychometric properties of the Beck Depression Inventory II (BDI-II) among community-dwelling older adults.  Behav Modif. 2008;32(1):3-20
PubMed   |  Link to Article
Ware JE Jr, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36), I: conceptual framework and item selection.  Med Care. 1992;30(6):473-483
PubMed   |  Link to Article
Jenkinson C, Layte R, Jenkinson D,  et al.  A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies?  J Public Health Med. 1997;19(2):179-186
PubMed   |  Link to Article
McHorney CA. Measuring and monitoring general health status in elderly persons: practical and methodological issues in using the SF-36 health survey.  Gerontologist. 1996;36(5):571-583
PubMed   |  Link to Article
Wells KB. The design of Partners in Care: evaluating the cost-effectiveness of improving care for depression in primary care.  Soc Psychiatry Psychiatr Epidemiol. 1999;34(1):20-29
PubMed   |  Link to Article
Wells K, Sherbourne CD, Schoenbaum M,  et al.  Five-year impact of quality improvement for depression: results of a group-level randomized controlled trial.  Arch Gen Psychiatry. 2004;61(4):378-386
PubMed   |  Link to Article
Senior AC, Kunik ME, Rhoades HM, Novy DM, Wilson NL, Stanley MA. Utility of telephone assessments in an older adult population.  Psychol Aging. 2007;22(2):392-397
PubMed   |  Link to Article
Stanley MA, Diefenbach GJ, Hopko DR. Cognitive behavioral treatment for older adults with generalized anxiety disorder: a therapist manual for primary care settings.  Behav Modif. 2004;28(1):73-117
PubMed   |  Link to Article
Borkovec TD, Nau SD. Credibility of analogue therapy rationales.  J Behav Ther. 1972;3:257-260
Link to Article
Roy-Byrne PP, Craske MG, Stein MB,  et al.  A randomized effectiveness trial of cognitive-behavioral therapy and medication for primary care panic disorder.  Arch Gen Psychiatry. 2005;62(3):290-298
PubMed   |  Link to Article
Arean P, Hegel M, Vannoy S, Fan MY, Unutzer J. Effectivness of problem-solving therapy for older, primary care patients with depression: results from the IMPACT project.  Gerontologist. 2008;48(3):311-323
PubMed   |  Link to Article
Rollman BL, Fischer GS, Zhu F, Belnap BH. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment.  J Gen Intern Med. 2008;23(4):447-450
PubMed   |  Link to Article

Figures

Place holder to copy figure label and caption
Figure. Flow of Participants Through Each Phase of the Study
Graphic Jump Location

Patients who dropped out did not participate in subsequent assessments; those who could not be contacted at one assessment were allowed to participate in subsequent assessments.

Tables

Table Graphic Jump LocationTable 1. Baseline Sociodemographic and Clinical Characteristics by Intervention Status
Table Graphic Jump LocationTable 2. Mean (SD) Scores on Outcomes Measures Across Time for Patients Receiving CBT or EUCa
Table Graphic Jump LocationTable 3. Mean Percentages of Patients Classified as Treatment Responders According to Meaningful Change Scores on the PSWQ (8.5) and the GADSS (2.0) at 3 and 15 Months

References

Beekman AT, Bremmer MA, Deeg DJ,  et al.  Anxiety disorders in later life: report from the Longitudinal Aging Study Amsterdam.  Int J Geriatr Psychiatry. 1998;13(10):717-726
PubMed   |  Link to Article
Tolin DF, Robison JT, Gaztambide S, Blank K. Anxiety disorders in older Puerto Rican primary care patients.  Am J Geriatr Psychiatry. 2005;13(2):150-156
PubMed
Brenes GA, Guralnik JM, Williamson JD,  et al.  The influence of anxiety on the progression of disability.  J Am Geriatr Soc. 2005;53(1):34-39
PubMed   |  Link to Article
Mantella RC, Butters MA, Dew MA,  et al.  Cognitive impairment in late-life generalized anxiety disorder.  Am J Geriatr Psychiatry. 2007;15(8):673-679
PubMed   |  Link to Article
Wetherell JL, Thorp SR, Patterson TL, Golshan S, Jeste DV, Gatz M. Quality of life in geriatric generalized anxiety disorder: a preliminary investigation.  J Psychiatr Res. 2004;38(3):305-312
PubMed   |  Link to Article
Stanley MA, Roberts RE, Bourland SL, Novy DM. Anxiety disorders among older primary care patients.  J Clin Geropyschol. 2001;(7):105-116
Brenes GA, Kritchevsky SB, Mehta KM,  et al.  Scared to death: results from the Health, Aging, and Body Composition study.  Am J Geriatr Psychiatry. 2007;15(3):262-265
PubMed   |  Link to Article
Beekman AT, de Beurs E, van Balkom AJ, Deeg DJ, van Dyck R, van Tilburg W. Anxiety and depression in later life: co-occurrence and communality of risk factors.  Am J Psychiatry. 2000;157(1):89-95
PubMed
Schoevers RA, Deeg DJ, van Tilburg W, Beekman AT. Depression and generalized anxiety disorder: co-occurrence and longitudinal patterns in elderly patients.  Am J Geriatr Psychiatry. 2005;13(1):31-39
PubMed
Pinquart M, Duberstein PR. Treatment of anxiety disorders in older adults: a meta-analytic comparison of behavioral and pharmacological interventions.  Am J Geriatr Psychiatry. 2007;15(8):639-651
PubMed   |  Link to Article
Allain H, Bentué-Ferrer D, Polard E, Akwa Y, Patat A. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review.  Drugs Aging. 2005;22(9):749-765
PubMed   |  Link to Article
Gum AM, Arean PA, Hunkeler E,  et al.  Depression treatment preferences in older primary care patients.  Gerontologist. 2006;46(1):14-22
PubMed   |  Link to Article
Hendriks GJ, Oude Voshaar RC, Keijsers GP, Hoogduin CA, van Balkom AJ. Cognitive-behavioural therapy for late-life anxiety disorders: a systematic review and meta-analysis.  Acta Psychiatr Scand. 2008;117(6):403-411
PubMed   |  Link to Article
Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders.  Psychiatr Clin North Am. 2005;28(4):871-896, ix
PubMed   |  Link to Article
Mohlman J, Gorenstein EE, Kleber M, de Jesus M, Gorman JM, Papp LA. Standard and enhanced cognitive-behavior therapy for late-life generalized anxiety disorder: two pilot investigations.  Am J Geriatr Psychiatry. 2003;11(1):24-32
PubMed
Mohlman J, Gorman JM. The role of executive functioning in CBT: a pilot study with anxious older adults.  Behav Res Ther. 2005;43(4):447-465
PubMed   |  Link to Article
Rollman BL, Belnap BH, Mazumdar S,  et al.  A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care.  Arch Gen Psychiatry. 2005;62(12):1332-1341
PubMed   |  Link to Article
Gilbody S, Bower P, Fletcher J, Richards D, Sutton AJ. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes.  Arch Intern Med. 2006;166(21):2314-2321
PubMed   |  Link to Article
Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings.  Am J Geriatr Psychiatry. 2003;11(1):92-96
PubMed
Wetherell JL, Ayers CR, Sorrell JT,  et al.  Modular psychotherapy for anxiety in older primary care patients.  Am J Geriatr PsychiatryIn press
PubMed
Spitzer RL, Williams JB, Kroenke K,  et al.  Utility of a new procedure for diagnosing mental disorders in primary care: the PRIME-MD 1000 study.  JAMA. 1994;272(22):1749-1756
PubMed   |  Link to Article
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician.  J Psychiatr Res. 1975;12(3):189-198
PubMed   |  Link to Article
First MB, Spitzer RL, Miriam G, Williams JBW. Structured Clinical Interview for DSM-IV Axis I Disorders, Research Version, Patient Edition With Psychotic.  New York, NY: Biometrics Research, New York State Psychiatric Institute; 1997
Meyer T, Miller ML, Metzger R, Borkovec TD. Development and validation of the Penn State Worry Scale.  Behav Res Ther. 1990;28(6):487-495
PubMed   |  Link to Article
Shear K, Belnap BH, Mazumdar S, Houck P, Rollman BL. Generalized Anxiety Disorder Severity Scale (GADSS): a preliminary validation study.  Depress Anxiety. 2006;23(2):77-82
PubMed   |  Link to Article
Hopko DR, Stanley MA, Reas DL,  et al.  Assessing worry in older adults: confirmatory factor analysis of the Penn State Worry Questionnaire and psychometric properties of an abbreviated model.  Psychol Assess. 2003;15(2):173-183
PubMed   |  Link to Article
Stanley MA, Beck JG, Novy DM,  et al.  Cognitive-behavioral treatment of late-life generalized anxiety disorder.  J Consult Clin Psychol. 2003;71(2):309-319
PubMed   |  Link to Article
Wetherell JL, Gatz M, Craske MG. Treatment of generalized anxiety disorder in older adults.  J Consult Clin Psychol. 2003;71(1):31-40
PubMed   |  Link to Article
Weiss BJ, Calleo J, Rhoades H,  et al.  The utility of the Generalized Anxiety Disorder Severity Scale (GADSS) with older adults in primary care.  Depress Anxiety. 2009;26(1):E10-E15
PubMed   |  Link to Article
Shear MK, Vander Bilt J, Rucci P,  et al.  Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A).  Depress Anxiety. 2001;13(4):166-178
PubMed   |  Link to Article
Skopp NA, Novy D, Kunik ME,  et al.  Investigation of cognitive behavior therapy.  Am J Geriatr Psychiatry. 2006;14(3):292
PubMed   |  Link to Article
Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory. 2nd ed. San Antonio, TX: Psychological Corp; 1996
Segal DL, Coolidge FL, Cahill BS, O’Riley AA. Psychometric properties of the Beck Depression Inventory II (BDI-II) among community-dwelling older adults.  Behav Modif. 2008;32(1):3-20
PubMed   |  Link to Article
Ware JE Jr, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36), I: conceptual framework and item selection.  Med Care. 1992;30(6):473-483
PubMed   |  Link to Article
Jenkinson C, Layte R, Jenkinson D,  et al.  A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies?  J Public Health Med. 1997;19(2):179-186
PubMed   |  Link to Article
McHorney CA. Measuring and monitoring general health status in elderly persons: practical and methodological issues in using the SF-36 health survey.  Gerontologist. 1996;36(5):571-583
PubMed   |  Link to Article
Wells KB. The design of Partners in Care: evaluating the cost-effectiveness of improving care for depression in primary care.  Soc Psychiatry Psychiatr Epidemiol. 1999;34(1):20-29
PubMed   |  Link to Article
Wells K, Sherbourne CD, Schoenbaum M,  et al.  Five-year impact of quality improvement for depression: results of a group-level randomized controlled trial.  Arch Gen Psychiatry. 2004;61(4):378-386
PubMed   |  Link to Article
Senior AC, Kunik ME, Rhoades HM, Novy DM, Wilson NL, Stanley MA. Utility of telephone assessments in an older adult population.  Psychol Aging. 2007;22(2):392-397
PubMed   |  Link to Article
Stanley MA, Diefenbach GJ, Hopko DR. Cognitive behavioral treatment for older adults with generalized anxiety disorder: a therapist manual for primary care settings.  Behav Modif. 2004;28(1):73-117
PubMed   |  Link to Article
Borkovec TD, Nau SD. Credibility of analogue therapy rationales.  J Behav Ther. 1972;3:257-260
Link to Article
Roy-Byrne PP, Craske MG, Stein MB,  et al.  A randomized effectiveness trial of cognitive-behavioral therapy and medication for primary care panic disorder.  Arch Gen Psychiatry. 2005;62(3):290-298
PubMed   |  Link to Article
Arean P, Hegel M, Vannoy S, Fan MY, Unutzer J. Effectivness of problem-solving therapy for older, primary care patients with depression: results from the IMPACT project.  Gerontologist. 2008;48(3):311-323
PubMed   |  Link to Article
Rollman BL, Fischer GS, Zhu F, Belnap BH. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment.  J Gen Intern Med. 2008;23(4):447-450
PubMed   |  Link to Article
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