Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT03630718
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2018-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With Primary Biliary Cholangitis in Women (CBP-HOPE)
Status:
COMPLETED
Status Verified Date:
2025-06
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:
CBP-HOPE
Brief Summary:
Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk. To treat fatigue in PBC, only medical treatments have been tested with limited efficacy or serious sides' effects. In other diseases, mostly cancer, psychological interventions showed efficacy on fatigue decrease. Most interventions consist in psychoeducation with: education about fatigue, development of self-care or coping techniques, activity management and learning to balance between activities and rest. Hypnosis, which consists in a body work for psycho-therapeutic use (e.g., through imagination), has also shown promising results. Moreover, psychological intervention efficacy seems to be influenced by patients' characteristics, such as personality. Therefore, the first aim of the present single-center randomized controlled phase 2 trial is to assess the efficacy of a psycho educational intervention and a hypnosis intervention on PBC patients' fatigue to demonstrate that both psychoeducational and hypnosis interventions decrease patient fatigue.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: