Psychological Treatments for Scleroderma

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Scleroderma; Systemic Sclerosis; Depression; Pain

Treatments: Behavioral: Disease/health education; Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist; Behavioral: Cognitive behavioral therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00007267

R01AR047219 (U.S. NIH Grant/Contract)

NIAMS-056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 3 patient groups

1

Experimental group

Description:

Participants will receive individual cognitive behavioral therapy

Treatment:

Behavioral: Cognitive behavioral therapy

2

Experimental group

Description:

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

Treatment:

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

3

Active Comparator group

Description:

Participants will receive a disease/health education intervention

Treatment:

Behavioral: Disease/health education