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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Other: Cognitive behavioral therapy (CBT); Behavioral: Listening therapy; Behavioral: Emotional processing and interpersonal therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802-3103
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of delivering emotional processing and interpersonal therapeutic techniques	Measured at baseline, post-treatment, and after 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• 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. doi: 10.1037/0033-3204.45.2.135.

Study record dates

Study Major Dates

• Study Start: July 1, 1996
• Primary Completion (Actual): July 1, 1998
• Study Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: August 3, 2009
• First Submitted That Met QC Criteria: August 3, 2009
• First Posted (Estimate): August 4, 2009

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: CBT; Interpersonal Therapy; Emotional-Focused Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: R01MH039172-02 (U.S. NIH Grant/Contract); 2R01MH039172-12 (U.S. NIH Grant/Contract)