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Completed

NCT Number: NCT00149760

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Standard Medical Care

Behavioral

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

Other names: Psychiatric consultation letter sent to primary physician

Cognitive-Affective Behavior Therapy

Behavioral

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

Other names: Emotionally-Focused Cognitive-Behavioral Therapy

Primary outcomes

  1. Clinical Global Impression Scale for Somatization Disorder

    Time frame: Measured at baseline and Months 4, 10, and 16

Secondary outcomes

  1. Physical functioning

    Time frame: Measured at baseline and Months 4, 10, and 16

  2. Health care utilization

    Time frame: Measured between Months 4 and 16

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Affective Behavior Therapy for Somatization

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2005
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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