DepressionDEPREVACTNCT03621488
Behavioral Self-activation and Virtual Reality in Depression
A study testing Efficacy of Behavioral Self-Activation with virtual reality and Efficacy of Behavioral Self-Activation without virtual reality in people with Depression, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Efficacy of Behavioral Self-Activation with virtual reality and Efficacy of Behavioral Self-Activation without virtual reality
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2019to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34295
Jérôme ATTAL, MD
Delphine CAPDEVIELLE, MD, PhD
About this study
Official title: 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.
Read more
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
- Depression
- Being tested
- Efficacy of Behavioral Self-Activation with virtual reality, Efficacy of Behavioral Self-Activation without virtual reality
- Keywords
- Behavioral Activation, Virtual reality, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of Behavioral Self-Activation with virtual realityOther
Efficacy of Behavioral Self-Activation with virtual reality
Efficacy of Behavioral Self-Activation without virtual realityOther
Efficacy of Behavioral Self-Activation without virtual reality
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Efficacy of Behavioral Self-Activation without virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of depression
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.
Measured: 0 and 6 months
Secondary outcomes (7)
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.
Measured: 0, 3 and 6 months
Evolution of depression
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months.
Measured: 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.
Measured: 3 and 6 months
Physical fatigue
Multidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
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.
Measured: 3 and 6 months
Therapeutic alliance
Attendance at sessions and visits during all the study.
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start29 Nov 2019
- Primary completion21 Feb 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- C2care
- Responsible party
- Sponsor
- Investigators
- Delphine CAPDEVIELLE, MD, PhD, Study director, University Hospitals of Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621488
- Sponsor's protocol ID
- RECHMPL17_0215
- Acronym
- DEPREVACT
- Status last verified
- Mar 2024
- First submitted
- 25 Jul 2018
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT03621488
- Acronym / sponsor ID
- DEPREVACT / RECHMPL17_0215
- Conditions
- Depression
- Keywords
- Behavioral Activation, Virtual reality, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- C2care
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 21 Feb 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Behavioral Self-Activation with virtual reality | Experimental | Other: Efficacy of Behavioral Self-Activation with virtual reality10 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. |
| Efficacy of Behavioral Self-Activation without virtual reality | Sham comparator | Other: Efficacy of Behavioral Self-Activation without virtual reality10 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy of Behavioral Self-Activation with virtual realityEfficacy of Behavioral Self-Activation with virtual reality | Other | Efficacy of Behavioral Self-Activation with virtual reality |
| Efficacy of Behavioral Self-Activation without virtual realityEfficacy of Behavioral Self-Activation without virtual reality | Other | Efficacy of Behavioral Self-Activation without virtual reality |
Primary outcome
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.
7 secondary outcomes
Evolution of depressive symptoms
Time frame: 0, 3 and 6 months
Evolution of depression
Time frame: 0 and 3 months
Life quality
Time frame: 3 and 6 months
Physical fatigue
Time frame: 3 and 6 months
Number of activities
Time frame: 3 and 6 months
Hopelessness
Time frame: 3 and 6 months
Therapeutic alliance
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine CAPDEVIELLE, MD, PhD study director
University Hospitals of Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy of Behavioral Self-Activation with virtual reality and Efficacy of Behavioral Self-Activation without virtual reality in people with Depression, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre DE CONNOR (+334.67.33.24.26, a-deconnor@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of depression (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.