Clinical trial NCT00007267: Psychological Treatments for Scleroderma
Official title: Psychosocial Interventions for Scleroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Depression
Scleroderma
Systemic Sclerosis
Keywords: Scleroderma
Systemic sclerosis
Depression
Pain
Disfigurement
Body image dissatisfaction
Cognitive-behavioral therapy
Self-help
Psychological intervention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2000-12-18
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: Measured at Week 8
Secondary outcomes:
measure: Body image dissatisfaction
timeFrame: Measured at Week 8
measure: Pain
timeFrame: Measured at Week 8
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jennifer A. Haythornthwaite
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):427-39. doi: 10.1016/s0889-857x(03)00020-6.