Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00007267
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2000-12-16
Brief Title:
Psychological Treatments for Scleroderma
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Psychosocial Interventions for Scleroderma
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 diseasehealth 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
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 diseasehealth 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-056 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR047219 |
| R01AR047219 | NIH | None | None |