Randomized Controlled Study of the Efficacy of Behavioral Self-Activation Through Virtual Reality in the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evolution of depression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •(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)
研究组 & 干预措施
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.
干预措施: Efficacy of Behavioral Self-Activation with virtual reality (Other)
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.
干预措施: Efficacy of Behavioral Self-Activation without virtual reality (Other)
结局指标
主要结局
Evolution of depression
时间窗: 0 and 6 months
Beck Depression Inventory version II (BDI-II; depression) ; decrease BDI-II score between 0 and 6 months.
次要结局
- Evolution of depression(0 and 3 months)
- Life quality(3 and 6 months)
- Therapeutic alliance(0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks; 13 and 6 months)
- Number of activities(3 and 6 months)
- Evolution of depressive symptoms(0, 3 and 6 months)
- Hopelessness(3 and 6 months)
- Physical fatigue(3 and 6 months)