Completed

Psychosocial Interventions for Scleroderma

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What is being tested

Cognitive behavioral therapy

+ Disease/health education

+ Self-help cognitive behavioral intervention facilitated by a psychologist

Behavioral
Who is being recruted

Behavior+9

+ Behavioral Symptoms

+ Connective Tissue Diseases

From 18 to 85 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2001
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitlePsychosocial Interventions for Scleroderma
NCT00007267
Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

89 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsConnective Tissue DiseasesDepressionNeurologic ManifestationsPainScleroderma, SystemicSigns and SymptomsSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesScleroderma, Diffuse

Criteria

4 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive individual cognitive behavioral therapy

Group II

Active Comparator
Participants will receive a disease/health education intervention

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Johns Hopkins Bayview Medical Center

Baltimore, United StatesOpen Johns Hopkins Bayview Medical Center in Google Maps
CompletedOne Study Center