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Am J Geriatr Psychiatry 11:92-96, February 2003
© 2003 American Association for Geriatric Psychiatry


Brief Report

Cognitive–Behavior Therapy for Late-Life Generalized Anxiety Disorder in Primary Care

Preliminary Findings

Melinda A. Stanley, Ph.D., Derek R. Hopko, Ph.D., Gretchen J. Diefenbach, Ph.D., Stacey L. Bourland, Ph.D., Hector Rodriguez, M.D., and Paula Wagener, Ph.D.

Received February 5, 2002; revised April 8, April 18, 2002; accepted April 25, 2002. From the University of Texas–Houston Medical School (MAS,DRH,GJD,SLB,PW) and Kelsey-Seybold Clinic and the Kelsey Research Foundation, Houston, TX (HR). Address correspondence to Dr. Stanley, Department of Psychiatry and Behavioral Sciences, University of Texas–Houston Medical School, 1300 Moursund Dr., Houston, TX 77030-3496. e-mail: Melinda.A.Stanley{at}uth.tmc.edu


    ABSTRACT
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: The authors present data from a pilot research program initiated to develop, refine, and test the outcomes of CBT-GAD/PC, a version of cognitive–behavior therapy (CBT) that targets the needs of older adults with generalized anxiety disorder (GAD) in primary care (PC). METHODS: The study involved a small, randomized clinical trial comparing the impact of CBT-GAD/PC to usual care (UC) in a sample of 12 older medical patients with GAD. RESULTS: Outcome data suggested significant improvements in worry and depression after CBT-GAD/PC, relative to UC. CONCLUSION: Authors discuss results in terms of the "real-world" applicability of this treatment for late-life GAD, and present implications for future research.

Key Words: Generalized Anxiety Disorder • Cognitive-Behavioral Therapy • Primary Care


    INTRODUCTION
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Anxiety disorders are prevalent in later life,1 and their impact on functioning is significant.2 Generalized anxiety disorder (GAD) is one of the most common anxiety disorders among older people, with associated decreased quality of life, high frequency of coexistent psychiatric disorders, and increased service use.3 Late-life anxiety may present a special problem for patients and practitioners in primary care, where prevalence and impact are particularly high4 and anxiety often goes unrecognized and untreated.5 Recognition may be most problematic for older patients who present with more somatic than psychological symptoms and who experience coexistent medical illnesses that complicate diagnosis.4 In a medical setting, GAD may be most difficult to recognize, given that associated symptoms are more general and pervasive than in other anxiety disorders.

Recent research has addressed the psychosocial treatment of late-life GAD, focusing largely on the effects of cognitive–behavior therapy (CBT), given the difficulties (for example, increased adverse effects, potential drug interactions) in prescribing psychotropic medications for older adults and the documented efficacy of CBT for GAD in younger adults.6 There now is evidence of the usefulness of CBT among older adults with GAD,7,8 with significant improvements in symptoms of worry, anxiety, and depression and with improved quality of life.

Available data, however, may not generalize to medical patients or settings. First, older adults in previous clinical trials have been relatively young, mostly white, well educated, physically healthy, and high-functioning. Thus, generalizability to more heterogeneous and dysfunctional patient groups who present to medical settings is questionable. Also, existing CBT interventions are not optimal for "real-world" settings. They require too many sessions (three to five), omit potentially important treatment components, and lack flexibility in the structure of treatment. A briefer, broader, and more flexible approach is needed in primary care.

The pilot program of research described here was initiated to develop, refine, and test the initial outcomes of CBT-GAD/PC, a version of CBT that targets the needs of older adults with GAD in primary care. The study tested outcomes in a small, randomized trial comparing CBT-GAD/PC with usual care (UC). Although the model of patient identification and treatment is focused on research goals and may not represent real-world practice, the study serves as an important first step in identifying appropriate patients and examining outcomes in primary care.


    METHODS
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Participants
Twelve patients with a diagnosis of GAD were recruited through waiting-room screens (n=9), physician referral (n=2), and educational brochures placed in waiting and examination rooms (n=1) from two large healthcare practices in the Houston metropolitan area. Interested patients of appropriate age were asked two GAD screening questions from the PRIME-MD. Subsequent diagnostic assessments involved administration of the Mini-Mental State Exam (MMSE) and Structured Diagnostic Interview for DSM-IV (SCID-I/P). The primary selection criteria included a DSM-IV diagnosis of GAD, willingness to participate in the study and consider nonpharmacological treatment for anxiety, and ability to speak English. Exclusion criteria included active suicidal intent, current psychosis or bipolar disorder, substance abuse within the past month, and cognitive impairment (MMSE <24).

A total of 928 patients were screened, 32 of whom screened positive. Diagnostic assessments were completed for 27 patients. Fifteen were excluded because there was no GAD diagnosis (n=14) or presence of psychosis (n=1). Demographic and clinical data for included patients are presented in Table 1. Forty-two percent were diagnosed with GAD only. Coexistent diagnoses included major depression (n=5; 42%), specific phobia (n=2; 17%), and social phobia (n=1; 8%).


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TABLE 1. Demographic and clinical characteristics of older patients in primary care with generalized anxiety disorder (N=12)
 
Measures
Outcome measures included the Penn State Worry Questionnaire (PSWQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Quality-of-Life Inventory (QOLI), and the Medical Outcomes Study Short Form–36 (SF–36). A clinician-rated measure of GAD severity was based on the GAD section of the SCID, with scores ranging from 0 (no worry or somatic symptoms) to 8 (very severe worry and very severe somatic symptoms). The Client Satisfaction Questionnaire (CSQ) and an Expectancy Rating Scale (ERS) were administered to patients in CBT-GAD/PC to assess treatment satisfaction, perceived credibility, and expectancies for success.

Treatment Development and Description
CBT-GAD/PC was developed on the basis of cognitive–behavioral procedures with demonstrated efficacy in academic clinical trials of late-life GAD,7,8 with modifications to meet the needs of older medical patients. Initially, a six-session CBT-GAD/PC manual was developed and administered in an open trial to eight medical patients with GAD. Data from this open trial suggested the potential usefulness of CBT-GAD/PC. However, we subsequently refined the manual to enhance outcome and address qualitative feedback from therapists and patients about usability of treatment. The duration of treatment was increased from six to eight sessions, with two additional sessions allowed for patients experiencing immediate crises or needing additional time to learn coping skills. Many treatment procedures (e.g., mnemonic aids, terminology used) and homework forms also were simplified. This eight-session version of CBT-GAD/PC was used here.

Treatment components included education, relaxation, cognitive therapy, problem-solving, exposure, and sleep-management skills. Relaxation involved breathing retraining and progressive deep-muscle relaxation. Cognitive components included thought-stopping, coping self-statements, and training in alternative thoughts and logical errors. Graduated exposure involved practicing coping skills in increasingly anxiety-producing situations. Problem-solving was based on procedures outlined by Meichenbaum,9 and sleep management followed Morin and colleagues.10 Therapists were asked to administer the interventions in a flexible fashion, reviewing all skills for each patient but allocating different amounts of time, depending upon patients' needs. Flexibility was recommended in the use of terminology, mode of presentation, and homework format to fit individual differences in educational backgrounds, cognitive skills, and sensory capacity. Therapists were encouraged to be flexible with the schedule of sessions to accommodate individual patient needs.

Procedures
After screening and diagnostic evaluation, patients were given pretreatment assessments and assigned randomly to CBT-GAD/PC (n=6) or UC (n=6), with one exception, to balance therapists equally across conditions. Therapists were postdoctoral- and residency-level clinicians supervised by the first author. CBT-GAD/PC was administered in either the medical clinic or the patient's home. Patients in UC received weekly telephone calls to assess symptom severity and the need for immediate treatment (e.g., for suicidal ideation). Medical staff was notified of patient participation by a note in the medical record.

Three patients (25.0%) dropped out of the study, two in UC and one in CBT-GAD/PC. One UC participant discontinued the study because of dissatisfaction with UC, and the other died during the treatment interval. The CBT-GAD/PC participant dropped out of the study because of the time commitment. All patients who completed CBT-GAD/PC did so in eight sessions, with an average duration of 8 weeks (standard deviation [SD]: 0.71). Patients in UC were contacted by telephone over an average of 8.8 weeks (SD: 3.59). All outcome measures were administered at pre- and post-treatment, and the PSWQ and BDI also were administered weekly, by telephone in UC and orally during treatment sessions in CBT-GAD/PC, to facilitate end-point analyses. For patients in CBT-GAD/PC, the ERS was administered after Session 1 and the CSQ at post-treatment.


    RESULTS
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Pre- and post-treatment scores were available for five patients who completed CBT-GAD/PC and four who completed UC. Also, PSWQ and BDI scores were available from Weeks 2 and 4 for two additional patients in UC and from Week 2 for one additional patient in CBT-GAD/PC. Mean scores are included in Table 2. Patients assigned to the two groups did not differ at pretreatment on any demographic or clinical variables. Group (UC; CBT-GAD/PC) x Time (Pre, Post) repeated-measures ANOVAs were used to evaluate treatment effects.


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TABLE 2. Outcome data
 
Significant interactions were demonstrated for GAD severity, worry (PSWQ), and depression (BDI). For each of these measures, simple effects tests indicated significant reduction in symptoms after CBT-GAD/PC (all ps <0.003), but no change after UC. A significant interaction also was observed on SF–36 vitality scores, although simple effects tests indicated significant worsening of symptoms in the UC group (p <0.05) and no change in the CBT-GAD/PC group.

Categorical data also suggested positive outcomes for CBT-GAD/PC. All five patients who completed CBT-GAD/PC met response criteria, defined as 20%-or-more improvement in two of three measures of worry and anxiety (GAD severity, PSWQ, BAI). Only one patient in UC (25%) met the same response criteria. This difference was significant (Fisher's exact test; p <0.05). The number of patients who no longer met criteria for GAD at post-treatment did not differ significantly in the two groups (two in CBT, one in UC).

Satisfaction with CBT-GAD/PC was high (CSQ=30.8 [SD: 1.10]; range: 4–32). CBT-GAD/PC patients also had high expectations for treatment success (Expectancy: 90% [SD: 10.00]; possible range: 0%–100%) and high ratings of credibility (Credibility: 9.0 [SD: 1.01]; possible range: 0–10).

Patients in UC and CBT-GAD/PC reported similar types of usual care over the study period. There were no significant differences in the number of mental health visits (0.25 in UC; 0.0 in CBT-GAD/PC), mental health referrals (1 in UC; 1 in CBT-GAD/PC), new psychotropic medications (1 in UC; 1 in CBT-GAD/PC), or total number of medical visits (1.75 in UC; 2.4 in CBT) over the treatment interval.


    DISCUSSION
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
The data here suggested some benefits of CBT-GAD/PC in a relatively diverse sample of older medical patients. Patients perceived the treatment as satisfactory and credible, and attrition rates were in an acceptable range. Significant improvement in worry and depression measures followed CBT-GAD/PC, but not UC. Response rates were equivalent to or greater than those in previous academic clinical trials,7,8 although response criteria here were slightly different, given the use of a briefer assessment battery. Rates of response to UC were low, but comparable to previous trials.7,8 This finding is of some concern here, however, given that patients were receiving usual care, and physicians were notified via the medical record of patient participation. Nonetheless, very few patients reported mental health visits or referrals over the study period, and only two patients received new psychotropic medications. As such, the data are consistent with reviews suggesting that patients typically do not receive adequate treatment for anxiety in medical settings, even when information about diagnosis is provided.5 The data here, though, suggest promise for improving the care of anxious older adults in medical settings, given that adding CBT-GAD/PC to the regimen of usual care appeared to be of benefit.

A number of study limitations suggest specific needs for future work. First, larger samples are clearly needed, as are independent evaluations of patient improvement and treatment integrity. In larger outcome trials, the impact of potential predictor variables, including recruitment source (e.g., waiting room screen versus physician referral), severity of coexistent medical conditions, and pretreatment severity of psychiatric symptoms, can be examined. Second, the potentially synergistic impact of CBT and medication needs to be examined, as does the long-term impact of treatment on service utilization, including medication use, and economic variables. Third, we need data regarding the long-term benefits of treatment and the potential importance of continued clinician contact and/or other forms of booster sessions. Finally, future research will need to examine the usefulness of services that are better integrated into the primary-care system. Here, significant effort was exerted in recruiting patients, and mental health specialists with expertise in late-life anxiety conducted assessments and treatment. For the intervention to be of optimal benefit, it will be necessary to investigate the ease with which staff already providing clinical care can be trained to identify GAD and provide treatment in the context of ongoing services. Despite these limitations, however, the data provide promising preliminary findings that may ultimately improve the provision of care for older medical patients with anxiety.


    ACKNOWLEDGMENTS
 
Data from this open trial are available from the first author upon request. A copy of the treatment manual is available from the first author.

Portions of the work were presented at the 35th Annual Convention of the Association for Advancement of Behavior Therapy, Philadelphia, PA, November 2001.

The authors thank Dr. Diane Novy, Dr. Mark Kunik, and three anonymous reviewers for comments on an earlier version of this work.

Dr. Hopko is now at the Department of Psychology, University of Tennessee, Knoxville; Dr. Diefenbach is at Hartford Hospital, The Institute of Living, Hartford, CT; and Dr. Bourland is in private practice in Houston, TX.

This research was supported in part by a grant from the NIMH (RO1-MH53932) to the first author.


    REFERENCES
 TOP
 ABSTRACT
 INTRODUCTION
 METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

  1. Stanley MA, Beck JG: Anxiety disorders. Clin Psychol Rev 2000; 20:731-754[CrossRef][Medline]
  2. De Beurs E, Beekman ATF, van Balkom AJLM, et al: Consequences of anxiety in older persons: its effect on disability, well-being, and use of health services. Psychol Med 1999; 29:583-593[CrossRef][Medline]
  3. Stanley MA: Generalized anxiety disorder in later life, in Generalized Anxiety Disorder: Symptomatology, Pathogenesis, and Management. Edited by Nutt D, Rickels K, Stein D. London, UK, Martin Dunitz Limited (in press)
  4. Kim HF, Braun U, Kunik ME: Anxiety and depression in medically ill older adults. Journal of Clinical Geropsychology 2001; 7:117-130
  5. Barlow DH, Lerner JA, Esler JL: Behavioral health care in primary care settings: recognition and treatment of anxiety disorders, in Health Psychology Through the Life-Span: Practice and Research Opportunities. Edited by Resnick RJ. Washington, DC, American Psychological Association, 1996, pp 133-148
  6. Brown TA, O'Leary TA, Barlow DH: Generalized anxiety disorder, in Clinical Handbook of Psychological Disorders: A Step-By-Step Treatment Manual, 3rd Edition. Edited by Barlow DH. New York, Guilford, 2001, pp 154-208
  7. Stanley MA, Beck JG, Novy DM, et al: Cognitive-behavioral treatment of late-life generalized anxiety disorder. J Consult Clin Psychol (in press)
  8. Wetherell JL, Gatz M, Craske MG: Treatment of generalized anxiety disorder in older adults. J Consult Clin Psychol (in press)
  9. Meichenbaum D: Stress Inoculation Training. New York, Pergamon, 1988
  10. Morin CM, Colecchi C, Stone J, et al: Behavioral and pharmacological therapies for late-life insomnia: a randomized, controlled trial. JAMA 1999, 281:991-999



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