Desensitization and Cognitive Therapy in General Anxiety.

Generalized Anxiety Disorder Clinical Trial

Official title:

Desensitization and Cognitive Therapy in General Anxiety.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951340
• Other study ID #: R01MH039172-02
• Secondary ID: R01MH039172-022R
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2009
• Last updated: September 18, 2017
• Start date: July 1996
• Est. completion date: December 1998

Study information

• Verified date: September 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1998
• Est. primary completion date: July 1998
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Other:
• Cognitive behavioral therapy (CBT)
15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques

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
• Listening therapy
15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Newman MG, Castonguay LG, Borkovec TD, Fisher AJ, Nordberg SS. AN OPEN TRIAL OF INTEGRATIVE THERAPY FOR GENERALIZED ANXIETY DISORDER. Psychotherapy (Chic). 2008 Jun 1;45(2):135-147. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of delivering emotional processing and interpersonal therapeutic techniques		Measured at baseline, post-treatment, and after 6, 12, and 24 months