Psychological Treatments for Scleroderma - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Johns Hopkins University
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00007267

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Psychosocial Interventions for Scleroderma

Resource links provided by NLM:

MedlinePlus related topics: Depression Scleroderma

U.S. FDA Resources

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
1: Experimental Participants will receive individual cognitive behavioral therapy	Behavioral: Cognitive behavioral therapy
2: Experimental Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist	Behavioral: Self-help cognitive behavioral intervention facilitated by a psychologist
3: Active Comparator 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

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

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Johns Hopkins University

Investigators

Principal Investigator:

Jennifer A. Haythornthwaite

Johns Hopkins University

More Information

Publications:

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

Responsible Party:	Department of Psychiatry & Behavioral Sciences ( Jennifer Haythornthwaite )
Study ID Numbers:	R01 AR47219, NIAMS-056
Study First Received:	December 16, 2000
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00007267 History of Changes
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

Study placed in the following topic categories:

Depression
Skin Diseases
Pain
Sclerosis
Depressive Disorder
Behavioral Symptoms
Mental Disorders

Mood Disorders
Connective Tissue Diseases
Scleroderma, Diffuse
Scleroderma
Scleroderma, Systemic
Scleroderma, Localized

Additional relevant MeSH terms:

Pathologic Processes
Depression
Skin Diseases
Mental Disorders
Connective Tissue Diseases
Mood Disorders

Scleroderma, Diffuse
Sclerosis
Scleroderma, Systemic
Depressive Disorder
Scleroderma, Localized
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 02, 2009