A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder

Michelle G. Newman

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Behavioral: Cognitive-Behavioral Therapy; Behavioral: Applied relaxation and self-control desensitization; Other: Cognitive therapy (CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT00635999

R01MH039172-01

Details and patient eligibility

About

This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.

Full description

Generalized anxiety disorder (GAD) is a common psychiatric disorder that affects nearly 6.8 million adults in the United States. GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern. The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult. GAD is often accompanied by physical symptoms as well, including muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, and shaking. People with GAD are also at a higher risk for other disorders, including depression and substance abuse, making early treatment of GAD important. Forms of psychotherapy that concentrate on stress management, relaxation techniques, and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD. This study will evaluate the effectiveness of three adaptive coping treatments, relaxation and self-control desensitization, cognitive behavioral therapy (CBT), and a combination of the two, in lessening anxiety in adults with GAD.

Participation in this study will last about 28 months. All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history, self-report questionnaires, and a physiological evaluation. After the first interview, participants will be asked to rate their level of anxiety four times a day in a diary. They will continue with these daily diary entries through the completion of treatment. Once participants complete the first 2 weeks' worth of daily ratings, participants will be assigned randomly to receive treatment with relaxation and self-control desensitization, CBT, or a combination of the two treatments. All participants will receive 14 weekly treatment sessions lasting between 1.5 and 2 hours each. During CBT sessions, participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Between sessions, all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries.

Upon completion of treatment, participants will repeat the initial assessments. Follow-up visits will occur at Months 6, 12, and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 week's worth of daily diary entries before each visit.

Enrollment: 76 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of GAD

Exclusion criteria

• Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome
• Currently receiving therapy for GAD or has previously received CBT
• Medical contributions to anxiety
• Currently taking antidepressant medication
• Current substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 3 patient groups

Purely Behavioral therapy

Experimental group

Description:

Participants will receive treatment with progressive and applied relaxation and self-control desensitization.

Treatment:

Behavioral: Applied relaxation and self-control desensitization

Cognitive-Behavioral Therapy

Experimental group

Description:

Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization

Treatment:

Behavioral: Cognitive-Behavioral Therapy

Cognitive Therapy (CT)

Experimental group

Description:

Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring.

Treatment:

Other: Cognitive therapy (CT)