Clinical trial NCT03621488: Behavioral Self-activation and Virtual Reality in Depression
Official title: Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Behavioral Activation
Virtual reality
Depression
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: C2care
First posted: 2018-08-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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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Primary outcomes:
measure: Evolution of depression
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Evolution of depressive symptoms
timeFrame: 0, 3 and 6 months
measure: Evolution of depression
timeFrame: 0 and 3 months
measure: Life quality
timeFrame: 3 and 6 months
measure: Physical fatigue
timeFrame: 3 and 6 months
measure: Number of activities
timeFrame: 3 and 6 months
measure: Hopelessness
timeFrame: 3 and 6 months
measure: Therapeutic alliance
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospitals of Montpellier, France
name: Delphine CAPDEVIELLE, MD, PhD
role: STUDY_DIRECTOR
References: