Cognitive Behavior Therapy for Somatization Disorder

Somatoform Disorders Clinical Trial

Official title:

Cognitive Behavior Therapy for Somatization Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276887
• Other study ID #: K08MH001662
• Secondary ID: K08MH001662DSIR
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2006
• Last updated: February 19, 2014
• Start date: September 1999
• Est. completion date: April 2004

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 effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2004
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Somatoform Disorders

Intervention

Behavioral:
• Cognitive Behavior Therapy

• Psychiatric Consultation Letter

Locations

Country	Name	City	State
United States	Department of Psychiatry, UMDNJ - RWJ Medical School	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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, 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of somatization disorder
Primary	Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)
Secondary	Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
Secondary	Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)