Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder
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Purpose
This study will test a version of cognitive behavioral therapy for generalized anxiety disorders that incorporates interpersonal and emotional processing techniques.
| Condition | Intervention |
|---|---|
|
Generalized Anxiety Disorder |
Behavioral: CBT Other: Interpersonal and emotional processing therapy Behavioral: supportive listening |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cognitive and Interpersonal Therapies for Generalized Anxiety |
- Anxiety symptoms [ Time Frame: Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups ] [ Designated as safety issue: No ]
| Enrollment: | 83 |
| Study Start Date: | July 1998 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Behavioral: CBT Behavioral: 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
|
Behavioral: CBT Other: Interpersonal and emotional processing therapy |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Penn State University | |
| University Park, Pennsylvania, United States, 16802 | |
| Study Director: | Michelle G. Newman, PhD | Penn State University |
| Principal Investigator: | Thomas D. Borkovec, PhD | Penn State University |
More Information
Publications:
| Responsible Party: | Michelle Newman, Professor, National Institute of Mental Health |
| ClinicalTrials.gov Identifier: | NCT00951652 History of Changes |
| Other Study ID Numbers: | R01 MH058593-02 |
| Study First Received: | August 3, 2009 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
CBT GAD Interpersonal Therapy Emotion-Focused Therapy |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013