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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
Sponsor:
Collaborator:
C2care
Information provided by (Responsible Party):
University Hospital, Montpellier

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Depression [ Time Frame: 6 months ]
    Beck Depression Inventory version II (BDI-II; depression)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 18 to 59,
  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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Information from the National Library of Medicine

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


Contacts
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Contact: Hanan Yazbek +334.67.33.95.97 h-yazbek@chu-montpellier.fr
Contact: Catherine Bortolon c-bortolon@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Not yet recruiting
Montpellier, France
Contact: Hanan Yazbek         
Sponsors and Collaborators
University Hospital, Montpellier
C2care

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03621488     History of Changes
Other Study ID Numbers: RECHMPL17_0215
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Behavioral Activation
Virtual reality
Depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders