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. We will also study the impact of depression on the psychological treatments. Because psychological approaches requiring a trained professional can be expensive and are often not available to most patients, we will also look at the effectiveness of a self-help treatment approach.

Condition	Treatment or Intervention	Phase
Pain Depression Scleroderma Systemic Sclerosis	Behavior: Cognitive-behavioral therapy  Behavior: Disease/health education	Phase II

Further Study Details: 

Expected Total Enrollment:  201

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. We 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, we will also examine the efficacy of a self-help intervention.

We will recruit 201 patients with systemic sclerosis who report symptoms of pain, depression, or distress about disfigurement and randomize 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. We will follow patients for 1 year after completing the active intervention phase.

These findings will increase our 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.

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

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

Maryland
      Johns Hopkins Bayview Medical Center, Baltimore,  Maryland,  21224,  United States

Study chairs or principal investigators

Jennifer A. Haythornthwaite,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  NIAMS-056; R01 AR47219
Record last reviewed:  September 2004
Last Updated:  December 10, 2004
Record first received:  December 16, 2000
ClinicalTrials.gov Identifier:  NCT00007267
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08