Cognitive Behavior Therapy for Somatization Disorder

Sponsor

University of Medicine and Dentistry of New Jersey (Other)

Overall Status

Completed

CT.gov ID

NCT00276887

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the long-term effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.

Condition or Disease	Intervention/Treatment	Phase
Somatoform Disorders	Behavioral: Cognitive Behavior Therapy Behavioral: Psychiatric Consultation Letter	Phase 2

Detailed Description

Somatization disorder is a chronic psychological condition that causes numerous physical complaints for which no underlying physical problem can be identified. The disorder often lasts for several years and results in substantial functional impairment. The physical complaints most frequently involve chronic pain and problems with the digestive, nervous, and reproductive systems. Neither pharmacological nor psychosocial treatments for this disorder have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is a treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie such thinking. This study will examine the long-term effects of CBT 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 CBT supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15 will assess specifically the long-term efficacy of the treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cognitive Behavior Therapy for Somatization Disorder

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Apr 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Symptoms of somatization disorder []
Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15) []

Secondary Outcome Measures

Health care utilization (measured the year before baseline and during the year after the 3-month assessment) []
Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Meets DSM-IV criteria for somatization disorder
Available for follow-up over the ensuing 15 months
English-speaking

Exclusion Criteria:

Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence
Active suicidal ideation
Unstable major medical condition
Plans to engage in additional psychotherapy during the first 3 months after study entry
Current use of any medication that has not been stabilized for the 2 months prior to study entry