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Psychological Treatments for Scleroderma

Primary Purpose

Pain, Depression, Scleroderma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Disease/health education
Self-help cognitive behavioral intervention facilitated by a psychologist
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Scleroderma, Systemic sclerosis, Depression, Pain, Disfigurement, Body image dissatisfaction, Cognitive-behavioral therapy, Self-help, Psychological intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will receive individual cognitive behavioral therapy

Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist

Participants will receive a disease/health education intervention

Outcomes

Primary Outcome Measures

Depressive symptoms

Secondary Outcome Measures

Body image dissatisfaction
Pain

Full Information

First Posted
December 16, 2000
Last Updated
August 8, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00007267
Brief Title
Psychological Treatments for Scleroderma
Official Title
Psychosocial Interventions for Scleroderma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Depression, Scleroderma, Systemic Sclerosis
Keywords
Scleroderma, Systemic sclerosis, Depression, Pain, Disfigurement, Body image dissatisfaction, Cognitive-behavioral therapy, Self-help, Psychological intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive individual cognitive behavioral therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants will receive a disease/health education intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Disease/health education
Intervention Type
Behavioral
Intervention Name(s)
Self-help cognitive behavioral intervention facilitated by a psychologist
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
Measured at Week 8
Secondary Outcome Measure Information:
Title
Body image dissatisfaction
Time Frame
Measured at Week 8
Title
Pain
Time Frame
Measured at Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A. Haythornthwaite
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12841303
Citation
Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):427-39. doi: 10.1016/s0889-857x(03)00020-6.
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Psychological Treatments for Scleroderma

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