Behavioral Self-activation and Virtual Reality in Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Other: Efficacy of Behavioral Self-Activation with virtual reality
* Other: Efficacy of Behavioral Self-Activation without virtual reality


Participation Criteria
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Eligibility Criteria
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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) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efficacy of Behavioral Self-Activation with virtual reality<br>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<br>* Efficacy of Behavioral Self-Activation with virtual reality<br>|
| Sham Comparator: Efficacy of Behavioral Self-Activation without virtual reality<br>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<br>* Efficacy of Behavioral Self-Activation without virtual reality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of depression | 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 | 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 | Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months. | 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. | 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. | 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. | 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. | 3 and 6 months | 
| Therapeutic alliance | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Activation, Virtual reality, Depression