Desensitization and Cognitive Therapy in General Anxiety.

Study Overview
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Brief Summary
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This study will test the feasibility and safety of adding interpersonal and emotional processing techniques to standard cognitive behavioral therapy for generalized anxiety disorder.

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) as 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 safety and feasibility of training therapists to deliver a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing. Participation in this study will include 14 weekly, 2-hour, individual therapy sessions. During the first hour of each session, all participants will receive standard CBT for GAD. 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 taking medications will be required to 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 15 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 hour-long portion of 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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Desensitization and Cognitive Therapy in General Anxiety.

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Other: Cognitive behavioral therapy (CBT)
* Behavioral: Emotional processing and interpersonal therapy
* Behavioral: Listening therapy


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 Exclusion Criteria: Concurrent psychosocial therapy or past adequate dosage of CBT 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

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 |
| --- | --- |
| Active Comparator: CBT with listening therapy<br>Participants will receive CBT with listening therapy. | Other: Cognitive behavioral therapy (CBT)<br>* 15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques<br>* Other names: CBT for GAD;Behavioral: Listening therapy<br>* 15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion<br>|
| Experimental: CBT with emotional processing and interpersonal therapy<br>Participants will receive CBT with emotional processing and interpersonal therapy. | Other: Cognitive behavioral therapy (CBT)<br>* 15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques<br>* Other names: CBT for GAD;Behavioral: Emotional processing and interpersonal therapy<br>* 15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of delivering emotional processing and interpersonal therapeutic techniques |  | Measured at baseline, post-treatment, and after 6, 12, and 24 months | 

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