A Phase 2 interventional study of Cognitive behavioral therapy and Disease/health education in Pain, Depression and Scleroderma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-09.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 89 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Johns Hopkins University is the lead sponsor of 1,782 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants will receive a disease/health education intervention
Behavioral: Disease/health education
Depressive symptoms
Time frame: Measured at Week 8
Body image dissatisfaction
Time frame: Measured at Week 8
Pain
Time frame: Measured at Week 8
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University