Behavioral Self-activation and Virtual Reality in Depression (DEPREVACT)

March 21, 2024 updated by: University Hospital, Montpellier

Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • University hospital of Montpellier
        • Principal Investigator:
          • Jérôme ATTAL, MD
        • Sub-Investigator:
          • Delphine CAPDEVIELLE, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

(1) History of head trauma or recent central neurological conditions only (2) Current treatment by seismotherapy or rTMS or CBT. (3) Exclusion from all substance-related disorders except tobacco-related disorder (DSM-V)

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efficacy of Behavioral Self-Activation with virtual reality

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 with virtual reality
Sham Comparator: Efficacy of Behavioral Self-Activation without virtual reality
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
Efficacy of Behavioral Self-Activation without virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of depression
Time Frame: 0 and 6 months
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.
0 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of depressive symptoms
Time Frame: 0, 3 and 6 months
Inventory of Depressive Symptomatology by the clinician (IDS-C) ; decrease IDS-C score between 0 and 3 months ; and between 0 and 6 months.
0, 3 and 6 months
Evolution of depression
Time Frame: 0 and 3 months
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months.
0 and 3 months
Life quality
Time Frame: 3 and 6 months
The Short Form (36) Health Survey (SF36) ; increase quality of life in the end of the treatment and three months later.
3 and 6 months
Physical fatigue
Time Frame: 3 and 6 months
Multidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
3 and 6 months
Number of activities
Time Frame: 3 and 6 months
Number of spontaneous activities performed during the week. Increase the number of activites in daily life in the end of the treatment and three months later.
3 and 6 months
Hopelessness
Time Frame: 3 and 6 months
Beck Hopelessness scale (feelings about the future, loss of motivation, and expectations); increase hope, in the end of the treatment and three months later.
3 and 6 months
Therapeutic alliance
Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months
Attendance at sessions and visits during all the study.
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

C2care

Investigators

  • Study Director: Delphine CAPDEVIELLE, MD, PhD, University Hospitals of Montpellier, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2019

Primary Completion (Estimated)

February 21, 2026

Study Completion (Estimated)

June 7, 2026

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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