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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00951340
First received: August 3, 2009
Last updated: November 4, 2013
Last verified: August 2009
  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:


Further study details as provided by Penn State University:

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
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: NCT00951340

Locations
United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802-3103
Sponsors and Collaborators
Penn State University
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, R01MH039172-02, 2RO1MH39172-12
Study First Received: August 3, 2009
Last Updated: November 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Penn State University:
CBT
Emotional-Focused Therapy
Interpersonal Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014