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Cognitive Behavior Therapy for Somatization Disorder

Primary Purpose

Somatoform Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Psychiatric Consultation Letter
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatoform Disorders focused on measuring Somatization Disorder, Multiple Medically Unexplained Symptoms, Cognitive Behavior Therapy, Mental Health

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Psychiatry, UMDNJ - RWJ Medical School

Outcomes

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)

Full Information

First Posted
January 11, 2006
Last Updated
February 19, 2014
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00276887
Brief Title
Cognitive Behavior Therapy for Somatization Disorder
Official Title
Cognitive Behavior Therapy for Somatization Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatoform Disorders
Keywords
Somatization Disorder, Multiple Medically Unexplained Symptoms, Cognitive Behavior Therapy, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
Psychiatric Consultation Letter
Primary Outcome Measure Information:
Title
Symptoms of somatization disorder
Title
Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)
Secondary Outcome Measure Information:
Title
Health care utilization (measured the year before baseline and during the year after the 3-month assessment)
Title
Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley A. Allen, PhD
Organizational Affiliation
University of Medicine & Dentistry of New Jersey - Robert Wood Johnson Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, UMDNJ - RWJ Medical School
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11764061
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.
Results Reference
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PubMed Identifier
12461199
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.
Results Reference
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Cognitive Behavior Therapy for Somatization Disorder

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