Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT03621488

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Hospital of Montpellier

Montpellier, France, 34295

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here