Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 2

Conditions: Somatization Disorder

Treatments: Behavioral: Cognitive-Affective Behavior Therapy; Behavioral: Augmented Standard Medical Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00149760

R21MH066831 (U.S. NIH Grant/Contract)

DAHBR 96-BHC

Details and patient eligibility

About

This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Full description

Somatization disorder is a syndrome characterized by the presence of multiple medically unexplained physical symptoms. It often results in substantial functional impairment and the need for extensive medical treatment. Neither pharmacological nor psychosocial treatments for the disease have demonstrated clinical success. People with somatization disorder may benefit from a treatment that integrates emotion-centered strategies into cognitive behavioral therapy. The long-term effectiveness of this treatment has not been established, however. This study will examine the long-term effect of cognitive-affective behavior therapy on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Participants in this open-label study will be randomly assigned to receive either cognitive-affective behavior therapy (CABT) or standard medical care that is augmented by a psychiatric consultation. Treatment will last 4 months. Assessments of somatic symptomatology, functional impairment, and health care costs will occur at screening, baseline (1 to 2 weeks after screening), and 4, 10, and 16 months after baseline. The visits at 10 and 16 months post-baseline will assess specifically the long-term efficacy of the treatment.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets DSM-IV criteria for somatization disorder
• Available for follow-up over the ensuing 18 months
• English-speaking

Exclusion criteria

• Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence (Other psychiatric comorbidity is not exclusionary)
• Active suicidal ideation
• Unstable major medical condition
• Plans to engage in additional psychotherapy during the first 6 months after enrollment
• Current use of any medication that has not been stabilized for the previous 2 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Augmented Standard Medical Care

Active Comparator group

Description:

Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.

Treatment:

Behavioral: Augmented Standard Medical Care

Cognitive-Affective Behavior Therapy

Experimental group

Description:

Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.

Treatment:

Behavioral: Cognitive-Affective Behavior Therapy