DEPREVACT: Behavioral Self-activation and Virtual Reality in Depression
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Efficacy of Behavioral Self-Activation with virtual reality 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
Efficacy of Behavioral Self-Activation with virtual reality
|
| Sham Comparator: Efficacy of Behavioral Self-Activation without virtual reality 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
Efficacy of Behavioral Self-Activation without virtual reality
|
Outcome Measures
Primary Outcome Measures
- Evolution of depression [0 and 6 months]
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.
Secondary Outcome Measures
- Evolution of depressive symptoms [0, 3 and 6 months]
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 [0 and 3 months]
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 3 months.
- Life quality [3 and 6 months]
The Short Form (36) Health Survey (SF36) ; increase quality of life in the end of the treatment and three months later.
- Physical fatigue [3 and 6 months]
Multidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
- Number of activities [3 and 6 months]
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 [3 and 6 months]
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 [0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months]
Attendance at sessions and visits during all the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18 to 70,
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Having a diagnosis of unipolar depressive disorder characterized (diagnostic criteria of depression of DSM-V),
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Primary depression and not secondary to another disorder (eg social phobia, OCD, severe personality disorder, ASD, TCA, ect.)
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Showing a score greater than or equal to 17 points on the IDB-II,
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Followed by a psychiatrist from the University Hospital of Montpellier or a liberal,
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Can read, understand and speak French,
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To be affiliated or beneficiary of a social security scheme.
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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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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Montpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
- C2care
Investigators
- Study Director: Delphine CAPDEVIELLE, MD, PhD, University Hospitals of Montpellier, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL17_0215