Actively Recruiting
Behavioral Self-activation and Virtual Reality in Depression
Led by University Hospital, Montpellier · Updated on 2024-03-22
80
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
C
C2care
Collaborating Sponsor
AI-Summary
What this Trial Is About
Depression is a major handicap in daily life and is often treated by behavioral activation (CA), including the Brief Behavioral Activation Treatment for Depression (BATD).The 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 therapist.The 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.
CONDITIONS
Official Title
Behavioral Self-activation and Virtual Reality in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70
- Diagnosis of unipolar depressive disorder based on DSM-V criteria
- Primary depression, not secondary to other disorders such as social phobia, OCD, severe personality disorder, ASD, or eating disorders
- Score of 17 or higher on the Beck Depression Inventory-II
- Currently followed by a psychiatrist at the University Hospital of Montpellier or in private practice
- Ability to read, understand, and speak French
- Affiliated with or beneficiary of a social security scheme
- Provided informed consent
You will not qualify if you...
- History of head trauma or recent central neurological conditions
- Currently receiving treatment with seismotherapy, rTMS, or cognitive behavioral therapy
- Substance-related disorders, except tobacco-related disorder
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Montpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
A
Alexandre DE CONNOR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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