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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

August 3, 2009
November 4, 2013
July 1996
July 1998   (final data collection date for primary outcome measure)
Feasibility of delivering emotional processing and interpersonal therapeutic techniques [ Time Frame: Measured at baseline, post-treatment, and after 6, 12, and 24 months ]
Same as current
Complete list of historical versions of study NCT00951340 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Feasibility of Adding Interpersonal and Emotional Processing Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder
Desensitization and Cognitive Therapy in General Anxiety.

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • 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
  • Behavioral: Listening therapy
    15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion
  • Active Comparator: CBT with listening therapy
    Participants will receive CBT with listening therapy.
    Interventions:
    • Other: Cognitive behavioral therapy (CBT)
    • Behavioral: Listening therapy
  • Experimental: CBT with emotional processing and interpersonal therapy
    Participants will receive CBT with emotional processing and interpersonal therapy.
    Interventions:
    • Other: Cognitive behavioral therapy (CBT)
    • Behavioral: Emotional processing and interpersonal therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 1998
July 1998   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00951340
R01 MH039172-02, R01MH039172-02, 2RO1MH39172-12
No
Thomas D. Borkovec, PhD, Penn State University
Penn State University
National Institute of Mental Health (NIMH)
Study Director: Michelle G. Newman, PhD Penn State University
Penn State University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP