NCT00007267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2000

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2001

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

5 years

First QC Date

December 16, 2000

Last Update Submit

August 8, 2017

Conditions

PainDepressionSclerodermaSystemic Sclerosis

Keywords

SclerodermaSystemic sclerosisDepressionPainDisfigurementBody image dissatisfactionCognitive-behavioral therapySelf-helpPsychological intervention

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    Measured at Week 8

Secondary Outcomes (2)

  • Body image dissatisfaction

    Measured at Week 8

  • Pain

    Measured at Week 8

Study Arms (3)

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

Interventions

Cognitive behavioral therapyBEHAVIORAL
1
Disease/health educationBEHAVIORAL
3
Self-help cognitive behavioral intervention facilitated by a psychologistBEHAVIORAL
2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

    PMID: 12841303BACKGROUND

MeSH Terms

Conditions

PainDepressionScleroderma, DiffuseScleroderma, Systemic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jennifer A. Haythornthwaite

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2000

First Posted

December 18, 2000

Study Start

June 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

US(1)