- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951652
Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder
Cognitive and Interpersonal Therapies for Generalized Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Penn State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBT plus supportive listening
14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be supportive listening
|
|
|
Active Comparator: CBT plus Interpersonal and emotional processing therapy
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety symptoms
Time Frame: Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups
|
Anxiety measures
|
Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Newman MG, Llera SJ. A novel theory of experiential avoidance in generalized anxiety disorder: a review and synthesis of research supporting a contrast avoidance model of worry. Clin Psychol Rev. 2011 Apr;31(3):371-82. doi: 10.1016/j.cpr.2011.01.008. Epub 2011 Jan 26.
- Newman MG, Castonguay LG, Borkovec TD, Fisher AJ, Boswell JF, Szkodny LE, Nordberg SS. A randomized controlled trial of cognitive-behavioral therapy for generalized anxiety disorder with integrated techniques from emotion-focused and interpersonal therapies. J Consult Clin Psychol. 2011 Apr;79(2):171-81. doi: 10.1037/a0022489.
- Przeworski A, Newman MG, Pincus AL, Kasoff MB, Yamasaki AS, Castonguay LG, Berlin KS. Interpersonal pathoplasticity in individuals with generalized anxiety disorder. J Abnorm Psychol. 2011 May;120(2):286-98. doi: 10.1037/a0023334.
- Boswell JF, Llera S, Newman MG, Castonguay LG. A Case of Premature Termination in a Treatment for Generalized Anxiety Disorder. Cogn Behav Pract. 2011 Aug 1;18(3):326-337. doi: 10.1016/j.cbpra.2010.09.001.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH058593-02 (U.S. NIH Grant/Contract)
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