Psychological Treatments for Scleroderma



Status:Completed
Conditions:Chronic Pain, Depression, Skin and Soft Tissue Infections, Neurology, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Musculoskeletal, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:8/10/2017
Start Date:June 2001
End Date:June 2006

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Psychosocial Interventions for Scleroderma

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.

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.

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
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Baltimore, MD
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