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OpenTrials
Completed

NCT Number: NCT00276887

Cognitive Behavior Therapy for Somatization Disorder

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, UMDNJ - RWJ Medical School

Piscataway, New Jersey, 08540, United States

About this study

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.

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 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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

Psychiatric Consultation Letter

Behavioral

Primary outcomes

  1. Symptoms of somatization disorder

  2. Functioning (measured with the Clinical Global Impression Scale for Somatization Disorder at Months 9 and 15)

Secondary outcomes

  1. Health care utilization (measured the year before baseline and during the year after the 3-month assessment)

  2. Health status (measured by the Medical Outcomes Study, SF-36, at Months 9 and 15)

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
1999
Primary completion
2003
Study completion
2004
First posted
Jan 13, 2006
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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