Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder

Study Overview
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Brief Summary
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This study will test a version of cognitive behavioral therapy for generalized anxiety disorders that incorporates interpersonal and emotional processing techniques.

Detailed Description
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Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) to be an effective treatment for GAD, but only half of people treated with CBT for GAD experience treatment benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not address interpersonal and emotional processing problems. This study will determine the efficacy of a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing among adults with GAD. Participation in this study will include 14 weeks of treatment and 2 years of follow-up visits. All participants will receive 14 weekly, 2-hour, individual therapy sessions and one maintenance session scheduled after completing treatment. During the first hour of each session, all participants will receive standard CBT. Participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. Participants may continue taking their current medications if they maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment. In-depth study assessments will take place at baseline and after completing the 14 weeks of therapy. Assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. Questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. The physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. Brief psychological assessments will also follow each therapy session. Follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.

Official Title
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Cognitive and Interpersonal Therapies for Generalized Anxiety

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: CBT
* Other: Interpersonal and emotional processing therapy
* Behavioral: supportive listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers Clinician's Severity Rating for GAD of 4 (moderate) or greater Exclusion Criteria: Concurrent psychosocial therapy or past adequate dosage of CBT Any medical contributions to anxiety Current substance abuse, psychosis, or organic brain syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: CBT plus supportive listening<br>14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be supportive listening | Behavioral: CBT<br> <br> Behavioral: supportive listening<br> <br> |
| Active Comparator: CBT plus Interpersonal and emotional processing therapy<br>14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be Interpersonal and emotional processing therapy | Behavioral: CBT<br> <br> Other: Interpersonal and emotional processing therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | Anxiety measures | Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, GAD, Interpersonal Therapy, Emotion-Focused Therapy