A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.

Detailed Description
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Generalized anxiety disorder (GAD) is a common psychiatric disorder that affects nearly 6.8 million adults in the United States. GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern. The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult. GAD is often accompanied by physical symptoms as well, including muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, and shaking. People with GAD are also at a higher risk for other disorders, including depression and substance abuse, making early treatment of GAD important. Forms of psychotherapy that concentrate on stress management, relaxation techniques, and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD. This study will evaluate the effectiveness of three adaptive coping treatments, relaxation and self-control desensitization, cognitive behavioral therapy (CBT), and a combination of the two, in lessening anxiety in adults with GAD. Participation in this study will last about 28 months. All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history, self-report questionnaires, and a physiological evaluation. After the first interview, participants will be asked to rate their level of anxiety four times a day in a diary. They will continue with these daily diary entries through the completion of treatment. Once participants complete the first 2 weeks' worth of daily ratings, participants will be assigned randomly to receive treatment with relaxation and self-control desensitization, CBT, or a combination of the two treatments. All participants will receive 14 weekly treatment sessions lasting between 1.5 and 2 hours each. During CBT sessions, participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Between sessions, all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries. Upon completion of treatment, participants will repeat the initial assessments. Follow-up visits will occur at Months 6, 12, and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 week's worth of daily diary entries before each visit.

Official Title
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Desensitization and Cognitive Therapy in General Anxiety

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Applied relaxation and self-control desensitization
* Other: Cognitive therapy (CT)
* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of GAD Exclusion Criteria: Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome Currently receiving therapy for GAD or has previously received CBT Medical contributions to anxiety Currently taking antidepressant medication Current substance abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Purely Behavioral therapy<br>Participants will receive treatment with progressive and applied relaxation and self-control desensitization. | Behavioral: Applied relaxation and self-control desensitization<br>* Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.<br>|
| Experimental: Cognitive-Behavioral Therapy<br>Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization | Behavioral: Cognitive-Behavioral Therapy<br>* Includes all of the techniques in the other 2 interventions.<br>|
| Experimental: Cognitive Therapy (CT)<br>Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring. | Other: Cognitive therapy (CT)<br>* CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High End State Function | Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire) | 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-group Change Represented as Cohen's d Effect Sizes | Cohen's d within-group effect sizes comparing pre-therapy assessment to assessment at 10-14 days after last therapy session, at 6-month follow-up, at 12-month follow-up, and at 24-month follow-up. Findings reported in table are Cohen's d effect sizes averaged over Hamilton Anxiety Scale (scores ranging from 0-56, higher scores mean more anxiety), the Assessor Severity Scale (scores ranging from 0-8, higher scores mean more severity), and the State-Trait Anxiety Inventory-Trait version (scores ranging from 20-80, higher scores mean more state anxiety). The within-group effective sizes are the posttherapy [or follow-up] mean minus pretherapy mean divided by the pretherapy standard deviation. | 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session |