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临床试验/NCT07112261
NCT07112261进行中(未招募)不适用

Thérapie Avatar Pour le Traitement du Trouble dépressif caractérisé réfractaire : Une étude Pilote

Ciusss de L'Est de l'Île de Montréal2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年8月1日最近更新:

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

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

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Dumais

MD, PhD

Ciusss de L'Est de l'Île de Montréal

研究点 (2)

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