Expired Study
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Piscataway, New Jersey 08854


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

R21 MH66831


NCT ID:

NCT00149760


Secondary ID:

R21MH066831


Study Acronym:


Brief Title:

Effectiveness of Cognitive-Affective Behavior Therapy for the Treatment of Somatization Disorder


Official Title:

Cognitive Affective Behavior Therapy for Somatization


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rutgers, The State University of New Jersey


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

88


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lesley A. Allen, PhD
Principal Investigator
Department of Psychiatry, Robert Wood Johnson Medical School

Study Dates

Start Date:August 2003
Completion Date:February 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:February 19, 2014
First Received Date:September 6, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Health care utilization
Time Frame:Measured between Months 4 and 16
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Physical functioning
Time Frame:Measured at baseline and Months 4, 10, and 16
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical Global Impression Scale for Somatization Disorder
Time Frame:Measured at baseline and Months 4, 10, and 16
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Augmented Standard Medical Care
Description:Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.
Arm Name:Augmented Standard Medical Care
Other Name:Psychiatric consultation letter sent to primary ph
Intervention Type:Behavioral
Name:Cognitive-Affective Behavior Therapy
Description:Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care
Arm Name:Cognitive-Affective Behavior Therapy
Other Name:Emotionally-Focused Cognitive-Behavioral Therapy

Study Arms

Study Arm Type:Experimental
Arm Name:Cognitive-Affective Behavior Therapy
Description:Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.
Study Arm Type:Active Comparator
Arm Name:Augmented Standard Medical Care
Description:Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Rutgers, The State University of New Jersey
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:16864762
Reference Type:Reference
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.
Reference Type:Reference
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. Review.
PMID:12461199
Reference Type:Reference
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.
PMID:11764061

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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