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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2010-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Somatization Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Augmented Standard Medical Care

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

Group Type ACTIVE_COMPARATOR

Augmented Standard Medical Care

Intervention Type BEHAVIORAL

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

Cognitive-Affective Behavior Therapy

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

Group Type EXPERIMENTAL

Cognitive-Affective Behavior Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Augmented Standard Medical Care

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

Intervention Type BEHAVIORAL

Cognitive-Affective Behavior Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Psychiatric consultation letter sent to primary physician Emotionally-Focused Cognitive-Behavioral Therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No