Trial record 6 of 203 for:    "systemic scleroderma"

Psychological Treatments for Scleroderma

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00007267
First received: December 16, 2000
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychosocial Interventions for Scleroderma

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 89
Study Start Date: June 2001
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive individual cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy
Experimental: 2
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007267

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Jennifer A. Haythornthwaite Johns Hopkins University
  More Information

Publications:
Responsible Party: Jennifer Haythornthwaite, Department of Psychiatry & Behavioral Sciences
ClinicalTrials.gov Identifier: NCT00007267     History of Changes
Other Study ID Numbers: R01 AR47219, NIAMS-056
Study First Received: December 16, 2000
Last Updated: February 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Scleroderma
Systemic sclerosis
Depression
Pain
Disfigurement
Body image dissatisfaction
Cognitive-behavioral therapy
Self-help
Psychological intervention

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Depression
Depressive Disorder
Sclerosis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014