Thérapie Avatar Pour le Traitement du Trouble dépressif caractérisé réfractaire : Une étude Pilote
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in depressive symptoms (Modified Hamilton Depression Rating Scale)
研究概览
简要总结
This pilot clinical trial aimed to evaluate the short-term efficacy of Avatar therapy for treatment-resistant major depressive disorder
详细描述
Major depressive disorder (MDD) is among the most common and disabling mental health conditions worldwide. However, treatment-resistant major depressive disorder (TR-MDD) is a prevalent clinical challenge and public health concern. While various pharmacological and psychotherapeutic treatments are available, a significant proportion of individuals do not achieve adequate symptom relief. Indeed, approximately 30% to 55% of individuals with MDD remain symptomatic after two adequate antidepressant trials, and psychotherapy has shown only modest efficacy in treatment-resistant cases. In this context, our research team developed Avatar therapy, an approach using virtual reality as a therapeutic tool to treat TR-MDD. The Avatar Therapy for TR-MDD displays strong experiential and relational components that are crucially missing in conventional interventions.
Throughout the 10 therapy sessions, participants were allowed to engage in a dialogue in virtual reality with an avatar representing a person who played a significant role in their depressive symptoms, which was animated in real-time by a therapist. The primary outcomes was severity of depressive symptoms. Secondary outcomes included severity of anxiety symptoms, self-esteem, quality of life and functioning. The investigators will also explore whether the greater improvements attributable to the Avatar Therapy persist in time.
Given the high prevalence of individuals with TR-MDD and the negative repercussions for individuals, their entourage, and society, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females over 18 years of age who meet the DSM-5 criteria for diagnosis of major depression with persistent depressive symptoms following inadequate response to two or more pharmacological treatment trials.
排除标准
- •Current SUD for a substance
- •Presence of neurological disorders ;
- •Presence of a severe and unstable physical illness ;
- •Inability to provide consent.
结局指标
主要结局
Change in depressive symptoms (Modified Hamilton Depression Rating Scale)
时间窗: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Depressive symptom severity was assessed using a clinician-rated scale composed of 25 items, derived from an unstructured clinical interview. Range 0-72, higher values indicating a more severe depressive symptoms.
Change in depressive symptoms (Patient Health Questionnaire-9)
时间窗: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Depressive symptom severity was also assessed using a 9-item self-report instrument. Range 0-27, higher values indicating a more severe depressive symptoms.
次要结局
- Change in anxiety symptoms (Generalized Anxiety Disorder-7)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in self-esteem (Rosenberg Self-Esteem Scale)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
- Deficit in functioning and disability (World Health Organization Disability Assessment Schedule 2.0)(Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months)
研究者
Alexandre Dumais
MD, PhD
Ciusss de L'Est de l'Île de Montréal
