NCT03621488

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 (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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
0mo left

Started Nov 2019

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Nov 2019Jun 2026

First Submitted

Initial submission to the registry

July 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2026

Expected
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

6.2 years

First QC Date

July 25, 2018

Last Update Submit

March 21, 2024

Conditions

Depression

Keywords

Behavioral ActivationVirtual realityDepression

Outcome Measures

Primary Outcomes (1)

  • Evolution of depression

    Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.

    0 and 6 months

Secondary Outcomes (7)

  • Evolution of depressive symptoms

    0, 3 and 6 months

  • Evolution of depression

    0 and 3 months

  • Life quality

    3 and 6 months

  • Physical fatigue

    3 and 6 months

  • Number of activities

    3 and 6 months

  • +2 more secondary outcomes

Study Arms (2)

Efficacy of Behavioral Self-Activation with virtual reality

EXPERIMENTAL

10 individual sessions of the Brief Behavioral Activation Treatment for Depression (BATD) program, lasting one hour, at the start of treatment, then half an hour thereafter, once a week \+ virtual reality activities of the session 4 to 9 lasting half an hour.

Other: Efficacy of Behavioral Self-Activation with virtual reality

Efficacy of Behavioral Self-Activation without virtual reality

SHAM COMPARATOR

10 individual sessions of the Brief Behavioral Activation Treatment for Depression (BATD) program, lasting one hour, at the start of treatment, then half an hour thereafter, once a week.

Other: Efficacy of Behavioral Self-Activation without virtual reality

Interventions

Efficacy of Behavioral Self-Activation with virtual realityOTHER

Efficacy of Behavioral Self-Activation with virtual reality

Efficacy of Behavioral Self-Activation with virtual reality
Efficacy of Behavioral Self-Activation without virtual realityOTHER

Efficacy of Behavioral Self-Activation without virtual reality

Efficacy of Behavioral Self-Activation without virtual reality

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 70,
  • Having a diagnosis of unipolar depressive disorder characterized (diagnostic criteria of depression of DSM-V),
  • Primary depression and not secondary to another disorder (eg social phobia, OCD, severe personality disorder, ASD, TCA, ect.)
  • Showing a score greater than or equal to 17 points on the IDB-II,
  • Followed by a psychiatrist from the University Hospital of Montpellier or a liberal,
  • Can read, understand and speak French,
  • To be affiliated or beneficiary of a social security scheme.
  • Collection of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Delphine CAPDEVIELLE, MD, PhD

    University Hospitals of Montpellier, France

    STUDY DIRECTOR

Central Study Contacts

Alexandre DE CONNOR

CONTACT

+334.67.33.24.26a-deconnor@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 8, 2018

Study Start

November 29, 2019

Primary Completion

February 21, 2026

Study Completion (Estimated)

June 7, 2026

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)