Psychological Treatments for Scleroderma
|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.|
|ClinicalTrials.gov Identifier: NCT00007267|
Recruitment Status : Completed
First Posted : December 18, 2000
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Depression Scleroderma Systemic Sclerosis||Behavioral: Cognitive behavioral therapy Behavioral: Disease/health education Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychosocial Interventions for Scleroderma|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
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|
- Depressive symptoms [ Time Frame: Measured at Week 8 ]
- Body image dissatisfaction [ Time Frame: Measured at Week 8 ]
- Pain [ Time Frame: Measured at Week 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007267
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Jennifer A. Haythornthwaite||Johns Hopkins University|