Desensitization and Cognitive Therapy in General Anxiety.

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 1

Conditions: Generalized Anxiety Disorder

Treatments: Behavioral: Emotional processing and interpersonal therapy; Behavioral: Listening therapy; Other: Cognitive behavioral therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00951340

R01MH039172-02 (U.S. NIH Grant/Contract)

2R01MH039172-12 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

CBT with listening therapy

Active Comparator group

Description:

Participants will receive CBT with listening therapy.

Treatment:

Other: Cognitive behavioral therapy (CBT)

Behavioral: Listening therapy

CBT with emotional processing and interpersonal therapy

Experimental group

Description:

Participants will receive CBT with emotional processing and interpersonal therapy.

Treatment:

Behavioral: Emotional processing and interpersonal therapy

Other: Cognitive behavioral therapy (CBT)