Psychological Treatments for Scleroderma

Depression Clinical Trial

Official title:

Psychosocial Interventions for Scleroderma

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
• 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

Related Conditions & MeSH terms

• Depression
• Pain
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

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