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

Somatization Disorder Clinical Trial

Official title:

Cognitive Affective Behavior Therapy for Somatization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149760
• Other study ID #: R21MH066831
• Secondary ID: R21MH066831DAHBR
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: February 19, 2014
• Start date: August 2003
• Est. completion date: February 2010

Study information

• Verified date: February 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Somatization Disorder
• Somatoform Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Department of Psychiatry, Robert Wood Johnson Medical School	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Allen LA, Escobar JI, Lehrer PM, Gara MA, Woolfolk RL. Psychosocial treatments for multiple unexplained physical symptoms: a review of the literature. Psychosom Med. 2002 Nov-Dec;64(6):939-50. Review. — View Citation

Allen LA, Woolfolk RL, Escobar JI, Gara MA, Hamer RM. Cognitive-behavioral therapy for somatization disorder: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1512-8. — View Citation

Allen LA, Woolfolk RL, Lehrer PM, Gara MA, Escobar JI. Cognitive behavior therapy for somatization disorder: a preliminary investigation. J Behav Ther Exp Psychiatry. 2001 Jun;32(2):53-62. — View Citation

Allen, Lesley A. Short-term therapy for somatization disorder: A cognitive behavioral approach. Journal of Cognitive Psychotherapy. Vol 14(4) Win 2000, 373-380.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression Scale for Somatization Disorder		Measured at baseline and Months 4, 10, and 16	No
Secondary	Physical functioning		Measured at baseline and Months 4, 10, and 16	No
Secondary	Health care utilization		Measured between Months 4 and 16	No