Psychological Treatments for Scleroderma
Behavioral: Cognitive behavioral therapy
Behavioral: Disease/health education
Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Psychosocial Interventions for Scleroderma|
- Depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||June 2001|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Participants will receive individual cognitive behavioral therapy
|Behavioral: Cognitive behavioral therapy|
Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
|Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist|
Active Comparator: 3
Participants will receive a disease/health education intervention
|Behavioral: Disease/health education|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007267
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Jennifer A. Haythornthwaite||Johns Hopkins University|