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Clinical Trials/NCT00951340
NCT00951340
Completed
Phase 1

Desensitization and Cognitive Therapy in General Anxiety.

Penn State University1 site in 1 country21 target enrollmentJuly 1996

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Penn State University
Enrollment
21
Locations
1
Primary Endpoint
Feasibility of delivering emotional processing and interpersonal therapeutic techniques
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 1996
End Date
December 1998
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle G. Newman

Professor of Psychology

Penn State University

Eligibility 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

Outcomes

Primary Outcomes

Feasibility of delivering emotional processing and interpersonal therapeutic techniques

Time Frame: Measured at baseline, post-treatment, and after 6, 12, and 24 months

Study Sites (1)

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