The Efficacy of Group-based Unified Protocol (UP) Programme for Improving Sleep and Mental Health
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Positive affect
研究概览
简要总结
Common mental disorders can be disabling and lead to a large burden of disease. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders was developed to address emotional disorders with evidence-based emotional-focused cognitive-behavioural techniques and is efficacious in reducing anxiety symptoms and depressive symptoms in adults. Previous research has demonstrated comparable effect of UP on reducing anxiety symptoms compared with the single-disorder protocol (SDP) for anxiety. Group-based UP was also implemented and tested. Given the fact that working populations are at a high risk of poor mental health, especially in light of the COVID pandemic with new unprecedented work situations and increased uncertainties, the present study aims to investigate the efficacy of Unified protocol on sleep and mental health in high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Working in local schools or education institutions
- •aged 18 or above
- •no severe or unstable mental health conditions at recruitment
- •no extensive prior training/practice with mindfulness
排除标准
- •psychotic disorders, bipolar disorder, severe alcohol disorder and substance abuse, acute and high suicidal risk
- •currently receiving taking other psychosocial interventions
结局指标
主要结局
Change in Positive affect
时间窗: week 1, week 5, week 9, 12 weeks after completion of intervention
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change in Negative affect
时间窗: week 1, week 5, week 9, 12 weeks after completion of intervention
Positive and Negative Affect Schedule (PANAS), 4 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
Change of insomnia symptoms
时间窗: week 1, week 5, week 9, 12 weeks after completion of intervention
Insomnia symptoms are measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
次要结局
- Change of Sleep Diary Measure - Time in Bed (TIB)(week 1, week 9, 12 weeks after completion of intervention)
- Change of Sleep Diary Measure - Wake After Sleep Onset (WASO)(week 1, week 9, 12 weeks after completion of intervention)
- Change in Mindfulness(week 1, week 9, 12 weeks after completion of intervention)
- Change of clinically anxiety symptoms(week 1, week 5, week 9, 12 weeks after completion of intervention)
- Change in Objective Sleep Measures - Sleep Efficiency (SE)(week 1, week 9, 12 weeks after completion of intervention)
- Change in General Health(week 1, week 5, week 9, 12 weeks after completion of intervention)
- Change in Common humanity(week 1, week 9, 12weeks after completion of intervention)
- Change in Decentering(week 1, week 9, 12 weeks after completion of intervention)
- Change of subjective mental well-being(week 1, week 5, week 9, 12 weeks after completion of intervention)
- Change of quality of life(week 1, week 5, week 9, 12weeks after completion of intervention)
- Change of Sleep Diary Measure - Sleep Efficiency (SE)(week 1, week 9, 12 weeks after completion of intervention)
- Change in Objective Sleep Measures - Total Sleep Time (TST)(week 1, week 9, 12 weeks after completion of intervention)
- Change in Self-compassion(week 1, week 9, 12 weeks after completion of intervention)
- TMSS-repair(week 1, week 9, 12 weeks after completion of intervention)
- RRS(week 1, week 5, week 9, 12 weeks after completion of intervention)
- Change in Emotion Regulation(week 1, week 5, week 9,12 weeks after completion of intervention)
- Change of pre-sleep arousal(week 1, week 9, 12 weeks after completion of intervention)
- Change of sleep reactivity(week 1, week 9, 12 weeks after completion of intervention)
- Change of Sleep Diary Measure - Total Sleep Time (TST)(week 1, week 9, 12 weeks after completion of intervention)
- Change of Sleep Diary Measure - Sleep Onset Latency (SOL)(week 1, week 9, 12 weeks after completion of intervention)
- Change in Objective Sleep Measures - Time in Bed (TIB)(week 1, week 9, 12 weeks after completion of intervention)
- Change of objective sleep measure (sleep onset latency, SOL)(week 1, week 9, 12 weeks after completion of intervention)
- Change in Objective Sleep Measures - Wake After Sleep Onset (WASO)(week 1, week 9, 12 weeks after completion of intervention)
- Change in Stress(week 1, week 5, week 9, 12 weeks after completion of intervention)
- Change in Compassion(week 1, week 9, 12 weeks after completion of intervention)
- Change of clinically depressive symptoms(week 1, week 5, week 9, 12 weeks after completion of intervention)
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong