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Psychological Treatments for Scleroderma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007267
First Posted: December 18, 2000
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Johns Hopkins University
December 16, 2000
December 18, 2000
August 9, 2017
June 2001
June 2006   (Final data collection date for primary outcome measure)
Depressive symptoms [ Time Frame: Measured at Week 8 ]
Not Provided
Complete list of historical versions of study NCT00007267 on ClinicalTrials.gov Archive Site
  • Body image dissatisfaction [ Time Frame: Measured at Week 8 ]
  • Pain [ Time Frame: Measured at Week 8 ]
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pain
  • Depression
  • Scleroderma
  • Systemic Sclerosis
  • Behavioral: Cognitive behavioral therapy
  • Behavioral: Disease/health education
  • Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist
  • Experimental: 1
    Participants will receive individual cognitive behavioral therapy
    Intervention: Behavioral: Cognitive behavioral therapy
  • Experimental: 2
    Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
    Intervention: Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist
  • Active Comparator: 3
    Participants will receive a disease/health education intervention
    Intervention: Behavioral: Disease/health education
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 ClinicalTrials.gov Identifier (NCT Number) 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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00007267
R01AR047219( U.S. NIH Grant/Contract )
R01AR047219 ( U.S. NIH Grant/Contract )
NIAMS-056
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Jennifer A. Haythornthwaite Johns Hopkins University
Johns Hopkins University
August 2017

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