- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00007267
Psychological Treatments for Scleroderma
Psychosocial Interventions for Scleroderma
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21224
- Johns Hopkins Bayview Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 1
Participants will receive individual cognitive behavioral therapy
|
|
|
Experimentell: 2
Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
|
|
|
Aktiv komparator: 3
Participants will receive a disease/health education intervention
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Depressive symptoms
Tidsram: Measured at Week 8
|
Measured at Week 8
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Body image dissatisfaction
Tidsram: Measured at Week 8
|
Measured at Week 8
|
|
Pain
Tidsram: Measured at Week 8
|
Measured at Week 8
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jennifer A. Haythornthwaite, Johns Hopkins University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01AR047219 (U.S.S. NIH-anslag/kontrakt)
- NIAMS-056
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