NCT00050583

Brief Summary

The purpose of this study is to compare cognitive behavior therapy (CBT) to medical care-as-usual for the treatment of patients with high levels of medically unexplained physical symptoms (Somatization Disorder). A second goal is to examine the effectiveness of CBT in Latinos, since Latinos suffer a relatively high prevalence of Somatization Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2001

Typical duration for phase_3

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

February 1, 2001

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

4.4 years

First QC Date

December 16, 2002

Last Update Submit

January 10, 2014

Conditions

Somatoform Disorders

Outcome Measures

Primary Outcomes (1)

  • CGI Improvement

    Post Treatment

Secondary Outcomes (1)

  • Hamilton Depression

    Post Treatment

Study Arms (2)

1

EXPERIMENTAL

10 Session modified CBT (including a relaxation component) administered by trained mental health clinicians at the primary care setting

Behavioral: Cognitive Behavioral TherapyBehavioral: CBT

2

NO INTERVENTION

"Treatment as Usual", defined as the use of a consultation letter and traditional primary care management.

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Ten Weekly Sessions of Manualized CBT

1
CBTBEHAVIORAL

Cognitive Behavioral Therapy

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Somatization disorder

You may not qualify if:

  • Bipolar disorder
  • Schizophrenia or other psychosis
  • Major Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ- Robert Wood Johnson Medical School; Dept. of Psychiatry

Piscataway, New Jersey, 08855-1392, United States

Location

Related Publications (1)

  • Escobar JI, Gara MA, Diaz-Martinez AM, Interian A, Warman M, Allen LA, Woolfolk RL, Jahn E, Rodgers D. Effectiveness of a time-limited cognitive behavior therapy type intervention among primary care patients with medically unexplained symptoms. Ann Fam Med. 2007 Jul-Aug;5(4):328-35. doi: 10.1370/afm.702.

    PMID: 17664499BACKGROUND

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Javier I Escobar, M.D.

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

  • Michael A Gara, Ph.D.

    Rutgers, The State University of New Jersey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Global Health

Study Record Dates

First Submitted

December 16, 2002

First Posted

December 17, 2002

Study Start

February 1, 2001

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

US(1)