Yoga Nidra Meditation for Insomnia and Posttraumatic Stress Symptoms: A Randomized-Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility: Participant Retention
研究概览
简要总结
This randomized feasibility study is designed to investigate the feasibility of recruitment and delivery of two variations (brief; full) of a virtual Integrative Restoration (iRest) yoga nidra meditation intervention in stressor- or trauma-exposed participants with insomnia and posttraumatic stress symptoms, compared to a waitlist control group. Feasibility will also be examined for data collection (daily sleep diaries and PTSD symptom surveys) and at-home polysomnography (PSG) study completion prior to and following the intervention. Feasibility measures will include study retention and-for the two yoga nidra groups-adherence to study protocol, and acceptability of the intervention will be assessed qualitatively, in semi-structured interviews, and quantitatively, with the Client Satisfaction Questionnaire, following the intervention. Acceptability of the daily surveys will also be assessed quantitatively.
Preliminary efficacy of the interventions on the primary treatment outcomes of insomnia and PTSD symptoms and symptom clusters will be assessed. Secondary outcomes include changes in specific sleep architecture assessed in an at-home polysomnogram (sleep stages, including stage N3 percentage, sleep spindles, rapid eye movement (REM) theta, total sleep time, wake after sleep onset time, sleep onset latency, sleep efficiency), daily sleep characteristics (total sleep time, sleep onset latency, wake after sleep onset time, sleep quality), daily PTSD symptoms, and mindfulness. Exploratory outcomes include sleep quality, experiential avoidance, emotion regulation, self-compassion, depression, anxiety, and nightmares.
详细描述
Participants will be randomly assigned to 1 of three groups: two remote yoga nidra interventions will be compared to a waitlist control group. The yoga nidra groups will be as follows: a high-dose condition in which participants will be instructed to engage in yoga nidra practice by listening to ~30-minute recordings every day for 8 weeks, and a low-dose condition in which participants will be instructed to engage in yoga nidra practice by listening to ~10-minute recordings 6 days per week and a ~30-minute recording one day per week for 8 weeks. The yoga nidra recordings are comprised of Integrative Restoration (iRest) yoga nidra scripts. Participants will be given the opportunity to listen to their provided recordings as often as they would like during the intervention. Frequency of practice sessions will be tracked on the website and recorded by participants in their daily surveys. In Week 10, participants in the waitlist control group will be randomly assigned to either low-dose or high-dose yoga nidra and given access to the recordings over the 8 weeks following the second PSG.
Daily PTSD symptoms and sleep will be recorded for two weeks prior to the intervention (baseline weeks) and throughout the intervention. At-home polysomnography will be completed immediately prior to the intervention (Week 2) and immediately following the intervention (Week 10), and questionnaires will be completed during the in-lab electrode application and removal sessions for the at-home polysomnography. During the in-lab sessions, resting state electroencephalography (EEG), heart rate variability (HRV), and skin conductance levels will also be recorded. Follow-up questionnaires will be administered to all participants 8 weeks after the second sleep study (Week 18) to assess primary treatment outcomes and mindfulness in waitlist participants after the intervention and maintenance of primary treatment outcomes and mindfulness following the intervention in yoga nidra high- and low-dose participants.
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
- Single (Participant)
盲法说明
Participants will be blinded to the presence of two different yoga nidra groups (high-dose and low-dose) during their participation in the study.
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
- •Endorses experiencing at least one lifetime very stressful or traumatic event that still causes distress
- •Score of 13 or higher on the 8-item PCL-5
- •Scoring 15 or higher on the Insomnia Severity Index, indicating the presence of moderate to severe insomnia
- •Being able and willing to listen to online yoga nidra audio recordings that may each be up to 35 minutes long daily for 8 weeks
- •Being willing to monitor sleep and PTSD symptoms for 10 weeks
- •Normal or corrected to normal hearing and vision
- •Fluent in English
- •Reliable daily access to the internet
- •Between the ages of 18 and 35
- •Reliable daily access to the internet
- •Willing to refrain from ingesting caffeine, alcohol, and recreational drugs the day of the sleep studies
排除标准
- •History of schizophrenia, psychotic disorder, or bipolar disorder
- •Currently receiving or seeking treatment for alcoholism or a substance abuse disorder
- •Currently taking part in another study intended to treat poor sleep or posttraumatic stress symptoms
- •Current endorsement of suicidality (score of 2 or higher on Item 9 of the BDI-II)
- •Self-harmed or attempted suicide within the past 6 months
- •Currently receiving treatment for any mental health disorder or sleep disorder
- •Current diagnosis of any sleep disorder, excluding insomnia or nightmare disorder
- •Currently taking benzodiazepines, nonbenzodiazepine receptor agonists, orexin agonists or antagonists, antiseizure medication, or any medications for sleep or psychiatric indications
- •Score of 5 or higher on STOP-BANG Questionnaire (indicating likelihood of moderate to severe obstructive sleep apnea)
- •Previous adverse experience with meditation
- •Current regular meditative practice (meditating once or more per month)
研究组 & 干预措施
Waitlist Control
During the intervention period, waitlist participants will not receive an intervention. At the end of Week 10, participants will be randomly assigned to low-dose yoga nidra or high-dose yoga nidra intervention for following the 8-week period.
Yoga nidra (30 minutes each day)
Participants will listen to ~30-minute yoga nidra meditation recordings every day for 8 weeks.
干预措施: Yoga nidra (full) (Behavioral)
Yoga nidra (one 30-minute session/week, six 10-minute sessions/week)
For 8 weeks, participants will be asked to listen to one ~30-minute yoga nidra meditation recording per week and six ~10-minute meditation recordings per week.
干预措施: Yoga nidra (brief) (Behavioral)
结局指标
主要结局
Feasibility: Participant Retention
时间窗: From baseline to follow-up (Weeks 1-10, Week 10, Week 18)
Retention will be quantified as percentage of participants that complete different levels of the acute protocol (i.e. ≤25%, 26-50%, 51-75%, \> 75% of daily questionnaires, and second at-home PSG) and percentage that complete the follow-up questionnaires.
Feasibility: Adherence to Yoga Nidra Protocol
时间窗: Throughout treatment (Week 2 to 10)
Adherence will be quantified as percentage of participants that complete 1-7 sessions in each week. Also, a measure of 'quality of meditation' (assessed using the PQ-M for each reported meditation) will serve as an additional measure of adherence.
次要结局
- Sleep Characteristics, Assessed in the At-home PSG(Change from baseline to post-treatment (Week 2; Week 10))
- Daily Sleep Characteristics(From baseline to end of treatment/waitlist period (Weeks 1 to 10))
- Daily PTSD Symptom Severity(From baseline to end of treatment/waitlist period (Weeks 1 to 10))
- PTSD Symptoms (PCL-5)(Change from baseline to end of treatment and follow-up (Week 2; 10; 18))
- Insomnia Symptoms (ISI)(Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18))
- Mindfulness (FFMQ-15)(Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18))
- Acceptability of Intervention (CSQ)(Post-treatment (Week 10))
- Acceptability Ratings of Daily Surveys(Post-treatment/waitlist (Week 10))