Baltimore, Maryland 21224

  • Systemic Sclerosis

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.


Study summary:

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.


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


Study is Available At:


Original ID:

R01AR047219


NCT ID:

NCT00007267


Secondary ID:

R01AR047219


Study Acronym:


Brief Title:

Psychological Treatments for Scleroderma


Official Title:

Psychosocial Interventions for Scleroderma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

89


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jennifer A. Haythornthwaite
Principal Investigator
Johns Hopkins University

Study Dates

Start Date:June 2001
Completion Date:June 2006
Completion Type:Actual
Primary Completion Date:June 2006
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 8, 2017
First Received Date:December 16, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Depressive symptoms
Time Frame:Measured at Week 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Body image dissatisfaction
Time Frame:Measured at Week 8
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pain
Time Frame:Measured at Week 8
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Self-help cognitive behavioral intervention facili
Arm Name:2
Intervention Type:Behavioral
Name:Disease/health education
Arm Name:3
Intervention Type:Behavioral
Name:Cognitive behavioral therapy
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:3
Description:Participants will receive a disease/health education intervention
Study Arm Type:Experimental
Arm Name:2
Description:Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
Study Arm Type:Experimental
Arm Name:1
Description:Participants will receive individual cognitive behavioral therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):427-39. Review.
PMID:12841303

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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