Cognitive Behavior Therapy for Somatization Disorder | NCT00276887

Studies
Cognitive Behavior Therapy for Somatization Disorder

NCT00276887

Sponsor

University of Medicine and Dentistry of New Jersey

Status

Completed

Last Update Posted

Feb 20, 2014Estimated

Enrollment

84Actual

Phase

Phase 2

Conditions

Somatoform Disorders

Interventions

Cognitive Behavior Therapy
Psychiatric Consultation Letter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K08MH001662	U.S. NIH Grant/Contract		View source
DSIR AT-CD

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Apr 2003Actual

Completion Date

Apr 2004Actual

First Submitted Date

Jan 11, 2006

First Submission Date that Met QC Criteria

Jan 11, 2006

First Posted Date

Jan 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2014

Last Update Posted Date

Feb 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of Medicine and Dentistry of New JerseyOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms of somatization disorder
Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lesley A. Allen, PhD	University of Medicine & Dentistry of New Jersey - Robert Wood Johnson Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry, UMDNJ - RWJ Medical School		Piscataway	New Jersey	08540	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11764061	Background	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.
12461199	Background	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.

ID	Term
D013001	Somatoform Disorders
D000092862	Psychological Well-Being

ID	Term
D001523	Mental Disorders
D010549	Personal Satisfaction
D001519	Behavior

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavior Therapy	Behavioral
Psychiatric Consultation Letter	Behavioral