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Clinical Trials/NCT00951652
NCT00951652
Completed
Not Applicable

Cognitive and Interpersonal Therapies for Generalized Anxiety

Michelle G. Newman1 site in 1 country83 target enrollmentJuly 1998

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Michelle G. Newman
Enrollment
83
Locations
1
Primary Endpoint
Anxiety symptoms
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study will test a version of cognitive behavioral therapy for generalized anxiety disorders that incorporates interpersonal and emotional processing techniques.

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.

Registry
clinicaltrials.gov
Start Date
July 1998
End Date
December 2005
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Michelle G. Newman
Responsible Party
Sponsor Investigator
Principal Investigator

Michelle G. Newman

Study Director

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
  • 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

Outcomes

Primary Outcomes

Anxiety symptoms

Time Frame: Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups

Anxiety measures

Study Sites (1)

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