Ignite Creation Date:
2024-05-06 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03621488
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2018-07-25
Brief Title:
Behavioral Self-activation and Virtual Reality in Depression
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression
Status:
RECRUITING
Status Verified Date:
2024-03
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:
DEPREVACT
Brief Summary:
Depression is a major handicap in daily life and is often treated by behavioral activation CA including the Brief Behavioral Activation Treatment for Depression BATDThe CA principle is to set up activities in keeping with the values of the individual Other tools associated with the CA deserve to be explored as virtual reality VR which offers scenarios and sensations similar to real life and a sense of life in a safe and controlled environment with the support of the therapistThe main objective is to compare the effectiveness of the program BATD with RV versus BATD without RV on the intensity of the depressive symptomatology and CA in everyday life
Methodology This is a randomized blinded study Inclusion criteria are 18 to 70 years old unipolar depression diagnosis Showing a score of 17 on the BDI-II 80 subjects will be recruited over 24 months and randomized into 2 groups 1 intervention group program BATD in VR 2 BATD program intervention group without RV lasting 45 minutes
Judgment Criteria The effectiveness of the intervention will be evaluated by the BDI-II scale and the Behavioral Activation for Depression Scale BADS
Outcomes A new management of depression AC with RV to improve the quality of life of the patient proof of its effectiveness a generalization of this care and recognition of its effectiveness in the scientific community
Methodology This is a randomized blinded study Inclusion criteria are 18 to 70 years old unipolar depression diagnosis Showing a score of 17 on the BDI-II 80 subjects will be recruited over 24 months and randomized into 2 groups 1 intervention group program BATD in VR 2 BATD program intervention group without RV lasting 45 minutes
Judgment Criteria The effectiveness of the intervention will be evaluated by the BDI-II scale and the Behavioral Activation for Depression Scale BADS
Outcomes A new management of depression AC with RV to improve the quality of life of the patient proof of its effectiveness a generalization of this care and recognition of its effectiveness in the scientific community
Detailed Description:
None
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