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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951652
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : November 4, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michelle G. Newman, Penn State University

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

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: CBT Other: Interpersonal and emotional processing therapy Behavioral: supportive listening Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive and Interpersonal Therapies for Generalized Anxiety
Study Start Date : July 1998
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
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

Primary Outcome Measures :
  1. Anxiety symptoms [ Time Frame: Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951652

United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Michelle G. Newman
National Institute of Mental Health (NIMH)
Study Director: Michelle G. Newman, PhD Penn State University
Principal Investigator: Thomas D. Borkovec, PhD Penn State University

Publications of Results:
Other Publications:
Responsible Party: Michelle G. Newman, Study Director, Penn State University Identifier: NCT00951652     History of Changes
Other Study ID Numbers: R01MH058593-02 ( U.S. NIH Grant/Contract )
R01MH058593-02 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by Michelle G. Newman, Penn State University:
Interpersonal Therapy
Emotion-Focused Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders