NCT00149760

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

Cognitive Affective Behavior Therapy for Somatization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Somatization Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Augmented Standard Medical Care	Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
BEHAVIORAL	Cognitive-Affective Behavior Therapy	Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care

Timeline

• Start date: 2003-08-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2005-09-08
• Last updated: 2014-02-20

Locations

1 site across 1 country: United States