RCT of an Acceptance-based Behavior Therapy for GAD

Study Overview
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Brief Summary
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The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.

Official Title
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Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Acceptance based behavioral therapy
* Behavioral: Applied relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: principal diagnosis of GAD at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy fluent in English 18 years or older Exclusion Criteria: bipolar disorder psychotic disorders substance dependence active suicidal intent if anxious symptomatology is due to a medical/physical condition

Ages Eligible for Study
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Minimum Age: 18 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: 1<br> | Behavioral: Acceptance based behavioral therapy<br>* 16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.<br>|
| Active Comparator: 2<br> | Behavioral: Applied relaxation<br>* 16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD |  | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up | 
| Hamilton Anxiety Rating Scale |  | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up | 
| Penn State Worry Questionnaire |  | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory - II |  | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up | 
| Quality of Life Inventory |  | pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up |