Clinical trial NCT00276887: Cognitive Behavior Therapy for Somatization Disorder
Official title: Cognitive Behavior Therapy for Somatization Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Somatoform Disorders
Keywords: Somatization Disorder
Multiple Medically Unexplained Symptoms
Cognitive Behavior Therapy
Mental Health
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-01-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of somatization disorder
measure: Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)
Secondary outcomes:
measure: Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
measure: Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Department of Psychiatry, UMDNJ - RWJ Medical School
state: New Jersey
Study officials:
affiliation: University of Medicine & Dentistry of New Jersey - Robert Wood Johnson Medical School
name: Lesley A. Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0005-7916(01)00020-9.
citation: 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. doi: 10.1097/01.psy.0000024231.11538.8f.