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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Newman, National Institute of Mental Health
ClinicalTrials.gov Identifier:
NCT00951652
First received: August 3, 2009
Last updated: April 25, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951652

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Michelle Newman
Investigators
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
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014