Psychological Treatments for Scleroderma

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

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2006-06-30

Brief Summary

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This study will examine the effectiveness of two psychological treatment approaches designed to help people who have scleroderma with three important areas of daily living: pain, depression, and distress about changes in appearance. The study will also evaluate the impact of depression on the two psychological treatments. Because psychological approaches requiring a trained professional can be expensive and are often not available to most patients, this study will also look at the effectiveness of a self-help treatment approach.

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Detailed Description

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This study will examine the efficacy of psychological interventions designed to target important areas of daily living for people with scleroderma: pain, depression, and distress about disfigurement. The study will also examine the effect of clinical depression on impact of the psychological treatments. Because psychological interventions requiring a trained professional can be costly and are often not available to the majority of patients, the study will also examine the efficacy of a self-help intervention.

The study will recruit 201 patients with systemic sclerosis who report symptoms of pain, depression, or distress about disfigurement and will randomly assign them to one of three interventions: individual cognitive behavioral therapy, self-help cognitive behavioral intervention facilitated by a psychologist, or a disease/health education intervention. An individual blinded to intervention assignment will collect measures of pain, functioning, distress about disfigurement, and mood at baseline and following the 8-week intervention period.

Both the cognitive-behavioral self-help materials and the educational materials (eight written chapters and audiotapes) will be designed for home use but will be supplemented by two individual sessions and two telephone contacts with the professional. Patients will be followed for 1 year after completing the active intervention phase.

These findings will increase understanding of the quality of life of individuals with scleroderma and determine whether self-help interventions can be used effectively to manage pain, depression, and distress about disfigurement.

Conditions

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Pain Depression Scleroderma Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants will receive individual cognitive behavioral therapy

Group Type EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

2

Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist

Group Type EXPERIMENTAL

Self-help cognitive behavioral intervention facilitated by a psychologist

Intervention Type BEHAVIORAL

3

Participants will receive a disease/health education intervention

Group Type ACTIVE_COMPARATOR

Disease/health education

Intervention Type BEHAVIORAL

Interventions

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Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Disease/health education

Intervention Type BEHAVIORAL

Self-help cognitive behavioral intervention facilitated by a psychologist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of CREST or systemic sclerosis
* Short-Form McGill Pain Questionnaire score 6 or higher
* Satisfaction with Appearance score of 15 or higher
* Beck Depression score of 10 or higher

Exclusion Criteria

* Patients reporting severe depression with suicidal ideation
* Delirium, dementia, or cognitive impairment (Mini Mental State Examination (MMSE) \< 24))
* Terminal illness with a life expectancy of less than 1 year

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No