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RecruitingNCT06888336

Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms

Yoga Nidra Meditation for Insomnia and Posttraumatic Stress Symptoms: A Randomized-Controlled Feasibility Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University College, London · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALYoga nidra (full)The intervention consists of remotely delivered audio recordings (\~30 minute length) of iRest yoga nidra meditation instructions that participants will be asked to listen to daily for 8 weeks, for a total listening time of about 3.5 hours each week. The yoga nidra practices will be in the tradition of iRest. They will include the following sections: intention setting, articulating a heartfelt desire, inner resource, body sensing, breath sensing, emotion and cognition sensing and opposites, welcoming joy, witnessing awareness, and integration. Each week includes an additional brief (\~2-5 minute) introduction to one of the iRest yoga nidra sections. Participants will be asked to lie on a lightly cushioned surface when listening to the practices. Participants are informed that they may opt to listen to the recordings more often but are instructed to listen to the recordings at least once per day.
BEHAVIORALYoga nidra (brief)The intervention will consist of remotely delivered audio recordings of yoga nidra meditation instructions. Participants will be asked to listen to one \~30-minute practice and six \~10-minute practices per week (total listening time of \~1.5 hours each week) for 8 weeks. The yoga nidra practices will be in the tradition of iRest. They will include the following sections: intention setting, articulating a heartfelt desire, inner resource, body sensing, breath sensing, emotion and cognition sensing and opposites, welcoming joy, witnessing awareness, and integration. Each week includes an additional brief (2-5 minute) introduction to one of the iRest yoga nidra sections. Participants will be asked to lie on a lightly cushioned surface when listening to the practices. Participants are informed that they may opt to listen to the recordings more than once a day but are instructed to listen to the 30-minute recording once per week and the 10-minute meditations the other 6 days of the week.

Timeline

Start date
2025-03-03
Primary completion
2025-10-01
Completion
2025-11-01
First posted
2025-03-21
Last updated
2025-03-21

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT06888336. Inclusion in this directory is not an endorsement.