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Psychological Treatments for Scleroderma

Psychosocial Interventions for Scleroderma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00007267
Enrollment
89
Registered
2000-12-18
Start date
2001-06-30
Completion date
2006-06-30
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Pain, Scleroderma, Systemic Sclerosis

Keywords

Scleroderma, Systemic sclerosis, Depression, Pain, Disfigurement, Body image dissatisfaction, Cognitive-behavioral therapy, Self-help, Psychological intervention

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.

Interventions

BEHAVIORALCognitive behavioral therapy
BEHAVIORALDisease/health education
BEHAVIORALSelf-help cognitive behavioral intervention facilitated by a psychologist

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Depressive symptomsMeasured at Week 8

Secondary

MeasureTime frame
PainMeasured at Week 8
Body image dissatisfactionMeasured at Week 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026