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Psychological Treatments for Scleroderma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Psychological Treatments for Scleroderma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Psychological Treatments for Scleroderma Clinical research trials and Psychological Treatments for Scleroderma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Psychological Treatments for Scleroderma. Psychological Treatments for Scleroderma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Psychological Treatments for Scleroderma clinical trial. Participants typically obtain the most effective healthcare available for their Psychological Treatments for Scleroderma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Psychological Treatments for Scleroderma  Psychological Treatments for Scleroderma
Psychological Treatments for Scleroderma
For Condition: Scleroderma,Systemic Sclerosis,Pain,Depression
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: 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. We will also study the impact of depression on the psychological treatments. Because psychological approaches requiring a trained professional can be expensive and are often not available to most patients, we will also look at the effectiveness of a self-help treatment approach.
Details: 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. We 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, we will also examine the efficacy of a self-help intervention. We will recruit 201 patients with systemic sclerosis who report symptoms of pain, depression, or distress about disfigurement and randomize 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. We will follow patients for 1 year after completing the active intervention phase. These findings will increase our 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 201
Location and Contact Information:
Overall Study Official:
JenniferHaythornthwaite, Principal Investigator, Johns Hopkins University
Johns Hopkins Bayview Medical Center *Recruiting*
Baltimore, Maryland,
United States
Recruiting Keya Medley 410-614-3396
Additional Information:
Study ID Numbers: NIAMS-056; R01 AR47219
Study Start Date: June 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007267
Other Scleroderma Studies:
1. Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
2. Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients with Systemic Sclerosis
3. Psychological Treatments for Scleroderma
4. Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
5. Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
Related Studies:
Other Scleroderma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Psychological Treatments for Scleroderma
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