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Completed

NCT Number: NCT00007267

Psychological Treatments for Scleroderma

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Disease/health education

Behavioral

Self-help cognitive behavioral intervention facilitated by a psychologist

Behavioral

Primary outcomes

  1. Depressive symptoms

    Time frame: Measured at Week 8

Secondary outcomes

  1. Body image dissatisfaction

    Time frame: Measured at Week 8

  2. Pain

    Time frame: Measured at Week 8

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

Psychosocial Interventions for Scleroderma

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Dec 18, 2000
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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