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Psychological Treatments for Scleroderma
This study has been completed.
Study NCT00007267   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: December 16, 2000   Last Updated: February 29, 2008   History of Changes

December 16, 2000
February 29, 2008
June 2001
June 2006   (final data collection date for primary outcome measure)
Depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00007267 on ClinicalTrials.gov Archive Site
  • Body image dissatisfaction [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Same as current
 
Psychological Treatments for Scleroderma
Psychosocial Interventions for Scleroderma

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Pain
  • Depression
  • Scleroderma
  • Systemic Sclerosis
  • Behavioral: Cognitive behavioral therapy
  • Behavioral: Disease/health education
  • Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist
  • Experimental: Participants will receive individual cognitive behavioral therapy
  • Experimental: Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
  • Active Comparator: Participants will receive a disease/health education intervention
Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):427-39. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
89
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00007267
Jennifer Haythornthwaite, Department of Psychiatry & Behavioral Sciences
R01 AR47219, NIAMS-056
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Johns Hopkins University
Principal Investigator: Jennifer A. Haythornthwaite Johns Hopkins University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP