Clinical trial NCT00149760: Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder
Official title: Cognitive Affective Behavior Therapy for Somatization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Somatization Disorder
Keywords: Cognitive Behavior Therapy
Treatment Outcome
Health Care Utilization
Somatization Disorder
Somatoform Disorder
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression Scale for Somatization Disorder
timeFrame: Measured at baseline and Months 4, 10, and 16
Secondary outcomes:
measure: Physical functioning
timeFrame: Measured at baseline and Months 4, 10, and 16
measure: Health care utilization
timeFrame: Measured between Months 4 and 16
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Department of Psychiatry, Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Department of Psychiatry, 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.
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.
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. doi: 10.1001/archinte.166.14.1512.