Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497101
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-04
Brief Title:
Effectiveness Trial of Temperament Based Therapy With Support TBT-S
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Effectiveness of Temperament Based Therapy With Support TBT-S A Novel 5-day Treatment for Anorexia Nervosa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa Specifically we will measure whether TBT-S in addition to treatment as usual TAU will be more effective than TAU alone in reducing eating disorder psychopathology Assessments will be conducted at four timepoints pre and post TBT-S and at 3 and 12 months follow-up Primary outcome measure is eating disorder psychopathology with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up compared to controls
Detailed Description:
Participants in the intervention arm will receive five days of TBT-S in addition to treatment as usual TBT-S is administered to three to six adult anorexia nervosa patients with up to four supports per patient The treatment structure consists of five consecutive days of treatment up to 75 hours each day Staff requirements for TBT-S are three clinicians one dietician and one medical staff Adults referred to a local psychiatric centre DPS for out-patient anorexia nervosa treatment and their supports will be eligible to participate in the study
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None