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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00007267
Other study ID # R01AR047219
Secondary ID R01AR047219NIAMS
Status Completed
Phase Phase 2
First received December 16, 2000
Last updated August 8, 2017
Start date June 2001
Est. completion date June 2006

Study information

Verified date August 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Cognitive behavioral therapy

Disease/health education

Self-help cognitive behavioral intervention facilitated by a psychologist


Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):427-39. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms Measured at Week 8
Secondary Body image dissatisfaction Measured at Week 8
Secondary Pain Measured at Week 8
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