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Behavioral Self-activation and Virtual Reality in Depression

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03621488
Acronym
DEPREVACT
Enrollment
80
Registered
2018-08-08
Start date
2019-11-29
Completion date
2026-06-07
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Behavioral Activation, Virtual reality, Depression

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.

Interventions

OTHEREfficacy of Behavioral Self-Activation with virtual reality

Efficacy of Behavioral Self-Activation with virtual reality

OTHEREfficacy of Behavioral Self-Activation without virtual reality

Efficacy of Behavioral Self-Activation without virtual reality

Sponsors

C2care
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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) \-

Design outcomes

Primary

MeasureTime frameDescription
Evolution of depression0 and 6 monthsBeck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.

Secondary

MeasureTime frameDescription
Evolution of depression0 and 3 monthsBeck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months.
Life quality3 and 6 monthsThe Short Form (36) Health Survey (SF36) ; increase quality of life in the end of the treatment and three months later.
Physical fatigue3 and 6 monthsMultidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
Evolution of depressive symptoms0, 3 and 6 monthsInventory of Depressive Symptomatology by the clinician (IDS-C) ; decrease IDS-C score between 0 and 3 months ; and between 0 and 6 months.
Hopelessness3 and 6 monthsBeck Hopelessness scale (feelings about the future, loss of motivation, and expectations); increase hope, in the end of the treatment and three months later.
Therapeutic alliance0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 monthsAttendance at sessions and visits during all the study.
Number of activities3 and 6 monthsNumber 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.

Countries

France

Contacts

Primary ContactAlexandre DE CONNOR
a-deconnor@chu-montpellier.fr+334.67.33.24.26

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026