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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Efficacy of Behavioral Self-Activation with virtual reality
Efficacy of Behavioral Self-Activation without virtual reality
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Behavioral Activation, Virtual reality, Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • University Hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Efficacy of Behavioral Self-Activation with virtual reality

Efficacy of Behavioral Self-Activation without virtual reality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evolution of depressive symptoms
Inventory of Depressive Symptomatology by the clinician (IDS-C) ; decrease IDS-C score between 0 and 3 months ; and between 0 and 6 months.
Evolution of depression
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months.
Life quality
The Short Form (36) Health Survey (SF36) ; increase quality of life in the end of the treatment and three months later.
Physical fatigue
Multidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
Number of activities
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.
Hopelessness
Beck Hopelessness scale (feelings about the future, loss of motivation, and expectations); increase hope, in the end of the treatment and three months later.
Therapeutic alliance
Attendance at sessions and visits during all the study.

Full Information

First Posted
July 25, 2018
Last Updated
December 24, 2021
Sponsor
University Hospital, Montpellier
Collaborators
C2care
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1. Study Identification

Unique Protocol Identification Number
NCT03621488
Brief Title
Behavioral Self-activation and Virtual Reality in Depression
Acronym
DEPREVACT
Official Title
Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
C2care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Behavioral Activation, Virtual reality, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efficacy of Behavioral Self-Activation with virtual reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Efficacy of Behavioral Self-Activation without virtual reality
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Efficacy of Behavioral Self-Activation with virtual reality
Intervention Description
Efficacy of Behavioral Self-Activation with virtual reality
Intervention Type
Other
Intervention Name(s)
Efficacy of Behavioral Self-Activation without virtual reality
Intervention Description
Efficacy of Behavioral Self-Activation without virtual reality
Primary Outcome Measure Information:
Title
Evolution of depression
Description
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.
Time Frame
0 and 6 months
Secondary Outcome Measure Information:
Title
Evolution of depressive symptoms
Description
Inventory of Depressive Symptomatology by the clinician (IDS-C) ; decrease IDS-C score between 0 and 3 months ; and between 0 and 6 months.
Time Frame
0, 3 and 6 months
Title
Evolution of depression
Description
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months.
Time Frame
0 and 3 months
Title
Life quality
Description
The Short Form (36) Health Survey (SF36) ; increase quality of life in the end of the treatment and three months later.
Time Frame
3 and 6 months
Title
Physical fatigue
Description
Multidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
Time Frame
3 and 6 months
Title
Number of activities
Description
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.
Time Frame
3 and 6 months
Title
Hopelessness
Description
Beck Hopelessness scale (feelings about the future, loss of motivation, and expectations); increase hope, in the end of the treatment and three months later.
Time Frame
3 and 6 months
Title
Therapeutic alliance
Description
Attendance at sessions and visits during all the study.
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre DE CONNOR
Phone
+334.67.33.24.26
Email
a-deconnor@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE, MD, PhD
Organizational Affiliation
University Hospitals of Montpellier, France
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme ATTAL, MD
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Self-activation and Virtual Reality in Depression

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