Behavioral Self-activation and Virtual Reality in Depression (DEPREVACT)
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|ClinicalTrials.gov Identifier: NCT03621488|
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : October 11, 2018
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 59 years old; unipolar depression diagnosis; Showing a score of ≥ 17 on the BDI-II. 70 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|
|Depression||Other: Efficacy of Behavioral Self-Activation with virtual reality Other: Efficacy of Behavioral Self-Activation without virtual reality||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression|
|Estimated Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||December 3, 2020|
|Estimated Study Completion Date :||December 3, 2020|
|Experimental: Efficacy of Behavioral Self-Activation with virtual reality||
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||
Other: Efficacy of Behavioral Self-Activation without virtual reality
Efficacy of Behavioral Self-Activation without virtual reality
- Depression [ Time Frame: 6 months ]Beck Depression Inventory version II (BDI-II; depression)
- physical fatigue [ Time Frame: 3,6 months ]Multidimensional Fatigue Inventory (physical fatigue); Reduce the level of physical fatigue, in the end of the treatment and three months later.
- Hopelessness [ Time Frame: 3,6 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.
- life quality [ Time Frame: 3,6 months ]SF36 Quality of Life ; increase quality of life in the end of the treatment and three months later.
- number of activities [ Time Frame: 3,6 months ]Number of activities performed during the week. increase the number of activites in daily life in the end of the treatment and three months later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621488
|Contact: Hanan Yazbekfirstname.lastname@example.org|
|Contact: Catherine Bortolonemail@example.com|
|University Hospital of Montpellier||Not yet recruiting|
|Contact: Hanan Yazbek|