Mindfulness-Based Stress Reduction Compared With Cognitive Behavioral Therapy to Improve Sleep and Mental Health in University Students With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
This study looked at university students who had trouble sleeping and compared two different programs designed to help with insomnia. One program was mindfulness-based stress reduction (MBSR), which focuses on meditation and awareness techniques, and the other was cognitive-behavioral therapy for insomnia (CBT-I), a structured approach that teaches strategies to change thoughts and habits around sleep. Participants were randomly assigned to one of the two programs. The researchers wanted to see how each program affected insomnia symptoms and related factors like stress, anxiety, mood, and overall quality of life. The researchers expected that CBT-I would lead to faster improvements right after the program, but they also believed that the mindfulness program would work just as well in the longer term, notably, three months after treatment.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female students aged 18 to 35 years from Université Laval;
- •Meet the Diagnostic and Statistical Manual of Mental Disorders 5th Version (DSM-5) criteria for insomnia disorder;
- •Report at least one consequence of insomnia on daytime functioning;
- •Are available and committed to attending group therapy sessions of approximately 1.5 hours each, held over 8 consecutive weeks.
排除标准
- •Presence of another major psychiatric disorder or other sleep disorder that could explain the insomnia symptoms;
- •Presence of a serious medical condition (e.g., chronic pain);
- •Previous participation in cognitive-behavioral therapy for insomnia (CBT-I) or prior completion of a mindfulness-based program (e.g., mindfulness-based stress reduction [MBSR], mindfulness-based cognitive therapy [MBCT]);
- •Refusal to discontinue the use of substances (e.g., over-the-counter sleep aids, marijuana, alcohol) for the sole purpose of sleep aids for the duration of the study;
- •Having a highly irregular sleep schedule (e.g., going to bed almost every night after 1:00 a.m. and waking up after 10:00 a.m.).
研究组 & 干预措施
Mindfulness based stress reduction (MBSR)
The participants randomized to this arm received the 8-week MBSR program.
干预措施: Mindfulness-based stress reduction (MBSR) (Behavioral)
Cognitive Behaviour Therapy for Insomnia (CBT-I)
The participants randomized to this arm received the 8-week CBT-I treatment.
干预措施: Cognitive Behaviour Therapy for Insomnia (CBT-I) (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire used to evaluate the severity of insomnia symptoms (e.g., difficulties falling asleep). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). Score interpretation: 0-7 = no clinically significant insomnia; 8-14 = subthreshold insomnia; 15-21 = clinical insomnia (moderate severity); 22-28 = clinical insomnia (severe).
Insomnia Severity Index (ISI)
时间窗: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire used to evaluate the severity of insomnia symptoms (e.g., difficulties falling asleep). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). Score interpretation: 0-7 = no clinically significant insomnia; 8-14 = subthreshold insomnia; 15-21 = clinical insomnia (moderate severity); 22-28 = clinical insomnia (severe).
次要结局
- The Patient Health Questionnaire-9 (PHQ-9)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Generalized Anxiety Disorder-7 (GAD-7)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Perceived Stress Scale (PSS-14)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Patient Health Questionnaire-9 (PHQ-9)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Generalized Anxiety Disorder-7 (GAD-7)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Perceived Stress Scale (PSS-14)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
- The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program)
研究者
Amélie Vézina
Principal Investigator
Laval University