Psychological Treatments for Scleroderma

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00007267

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Depression Scleroderma Systemic Sclerosis	Behavioral: Cognitive behavioral therapy Behavioral: Disease/health education Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Psychosocial Interventions for Scleroderma

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Participants will receive individual cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy

Experimental: 2

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

Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist

Active Comparator: 3

Participants will receive a disease/health education intervention

Behavioral: Disease/health education

Outcome Measures

Primary Outcome Measures

Depressive symptoms [Measured at Week 8]

Secondary Outcome Measures

Body image dissatisfaction [Measured at Week 8]
Pain [Measured at Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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