Psychological Treatments for Scleroderma

Study Overview
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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.

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.

Official Title
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Psychosocial Interventions for Scleroderma

Conditions
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Pain, Depression, Scleroderma, Systemic Sclerosis

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Behavioral: Disease/health education
* Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive individual cognitive behavioral therapy | Behavioral: Cognitive behavioral therapy<br> <br> |
| Experimental: 2<br>Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist | Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist<br> <br> |
| Active Comparator: 3<br>Participants will receive a disease/health education intervention | Behavioral: Disease/health education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms |  | Measured at Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body image dissatisfaction |  | Measured at Week 8 | 
| Pain |  | Measured at Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleroderma, Systemic sclerosis, Depression, Pain, Disfigurement, Body image dissatisfaction, Cognitive-behavioral therapy, Self-help, Psychological intervention