Feasibility of Adding Interpersonal and Emotional Processing Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder - Full Text View

Purpose

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

Condition	Intervention	Phase
Generalized Anxiety Disorder	Other: Cognitive behavioral therapy (CBT) Behavioral: Emotional processing and interpersonal therapy Behavioral: Listening therapy	Phase 1

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:	Desensitization and Cognitive Therapy in General Anxiety.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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

Primary Outcome Measures:

Feasibility of delivering emotional processing and interpersonal therapeutic techniques [ Time Frame: Measured at baseline, post-treatment, and after 6, 12, and 24 months ]

Enrollment:	21
Study Start Date:	July 1996
Study Completion Date:	December 1998
Primary Completion Date:	July 1998 (Final data collection date for primary outcome measure)

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951340

Locations

United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802-3103

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Study Director:

Michelle G. Newman, PhD

Penn State University

More Information

Publications:

Newman, M. G., Castonguay, L. G., Borkovec, T. D., Fisher, A. J., & Nordberg, S. S. (2008). An open trial of integrative therapy for generalized anxiety disorder. Psychotherapy: Theory, Research, Practice, Training. Special Issue: New treatments in psychotherapy, 45, 135-147.

Responsible Party:	Thomas D. Borkovec, PhD, Penn State University
ClinicalTrials.gov Identifier:	NCT00951340 History of Changes
Other Study ID Numbers:	R01 MH039172-02, 2RO1MH39172-12
Study First Received:	August 3, 2009
Last Updated:	August 5, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

CBT
Emotional-Focused Therapy
Interpersonal Therapy

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013