- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00007267
Psychological Treatments for Scleroderma
Psychosocial Interventions for Scleroderma
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins Bayview Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Participants will receive individual cognitive behavioral therapy
|
|
|
Eksperimentel: 2
Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
|
|
|
Aktiv komparator: 3
Participants will receive a disease/health education intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Depressive symptoms
Tidsramme: Measured at Week 8
|
Measured at Week 8
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Body image dissatisfaction
Tidsramme: Measured at Week 8
|
Measured at Week 8
|
|
Pain
Tidsramme: Measured at Week 8
|
Measured at Week 8
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jennifer A. Haythornthwaite, Johns Hopkins University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01AR047219 (U.S. NIH-bevilling/kontrakt)
- NIAMS-056
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