NCT00149760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

6.5 years

First QC Date

September 6, 2005

Last Update Submit

February 19, 2014

Conditions

Somatization Disorder

Keywords

Cognitive Behavior TherapyTreatment OutcomeHealth Care UtilizationSomatization DisorderSomatoform Disorder

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression Scale for Somatization Disorder

    Measured at baseline and Months 4, 10, and 16

Secondary Outcomes (2)

  • Physical functioning

    Measured at baseline and Months 4, 10, and 16

  • Health care utilization

    Measured between Months 4 and 16

Study Arms (2)

Augmented Standard Medical Care

ACTIVE COMPARATOR

Participants will receive standard medical care augmented by a psychiatric consultation letter sent to the participants' primary care physician.

Behavioral: Augmented Standard Medical Care

Cognitive-Affective Behavior Therapy

EXPERIMENTAL

Participants will receive individually administered cognitive-affective behavior therapy as well as augmented standard medical care.

Behavioral: Cognitive-Affective Behavior Therapy

Interventions

Augmented Standard Medical CareBEHAVIORAL

Participants' physicians will receive a letter making specific treatment recommendations for primary care treatment.

Also known as: Psychiatric consultation letter sent to primary physician
Augmented Standard Medical Care
Cognitive-Affective Behavior TherapyBEHAVIORAL

Individually-administered cognitive-behavioral therapy with an emotional focus in addition to augmented standard medical care

Also known as: Emotionally-Focused Cognitive-Behavioral Therapy
Cognitive-Affective Behavior Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for somatization disorder
  • Available for follow-up over the ensuing 18 months
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

Related Publications (4)

  • 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.

    PMID: 11764061BACKGROUND

  • 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.

    PMID: 12461199BACKGROUND

  • Allen, Lesley A. Short-term therapy for somatization disorder: A cognitive behavioral approach. Journal of Cognitive Psychotherapy. Vol 14(4) Win 2000, 373-380.

    BACKGROUND

  • 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.

    PMID: 16864762BACKGROUND

MeSH Terms

Conditions

Somatoform DisordersPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Mental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lesley A. Allen, PhD

    Department of Psychiatry, Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

August 1, 2003

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

US(1)