MedTrace Logo

Behavioral Self-activation and Virtual Reality in Depression

NCT03621488 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-22

No results posted yet for this study

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 (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

Interventions

OTHER

Efficacy of Behavioral Self-Activation with virtual reality

Efficacy of Behavioral Self-Activation with virtual reality

OTHER

Efficacy of Behavioral Self-Activation without virtual reality

Efficacy of Behavioral Self-Activation without virtual reality

Sponsors & Collaborators

  • C2care

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Delphine CAPDEVIELLE, MD, PhD · University Hospitals of Montpellier, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2026-02-21
Completion
2026-06-07

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621488 on ClinicalTrials.gov