Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.
研究概览
简要总结
This study is a randomized controlled trial (comparing "occupational activities" versus "dog-assisted therapy" arms) investigating the effectiveness of animal-assisted therapy with dogs in small groups of participants with depression. Patients in the "dog-assisted therapy" arm will participate in two group sessions (groups of 3 to 7 participants) of canine-assisted therapy, supervised by a healthcare professional certified in animal-assisted therapy alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks. Patients in the "occupational activities" arm will participate in two group sessions (groups of 3 to 7 participants) of occupational activities, supervised by a healthcare professional experienced in group occupational activities alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 65
- •Patient affiliated with a social security scheme
- •Patient hospitalized under voluntary psychiatric care
- •Diagnosis of depression according to DSM-5-TR criteria
- •QIDS-C16 score ≥11 at screening
- •QIDS-SR16 score ≥11 at screening and inclusion
排除标准
- •Severe comorbid psychiatric disorder
- •Imminent risk of suicidal behavior
- •Unstable comorbid somatic condition
- •Vulnerable patients (under guardianship, curatorship, or judicial protection)
- •Known fear of dogs
- •Known allergy to dog fur
结局指标
主要结局
Change in the 17-item Hamilton Depression Rating Scale (HDRS) score from baseline to 6 weeks.
时间窗: Baseline and week 6
The 17-item Hamilton Depression Rating Scale (HDRS) is a validated scale for depression assessment, its score is rated between 0 and 52 and a higher score means a more depressed state
次要结局
- Evolution of the 17-item Hamilton scale score between 0 and 3 weeks.(Baseline and week 3)
- Evolution of the quality of life scale score (WHOQOL-BREF) at 3 and 6 weeks, compared to the initial score at W0.(Baseline and weeks 3 and 6)
- Evaluation of the number of adverse events and serious adverse events related to the therapy under study.(From baseline up to 6 weeks)