Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms

NCT ID: NCT06888336

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-11-30

Brief 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

Posttraumatic Stress Disorder (PTSD); Insomnia; Stressor, Psychological; Psychological Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga nidra (30 minutes each day)

Participants will listen to \~30-minute yoga nidra meditation recordings every day for 8 weeks.

Group Type: EXPERIMENTAL

Yoga nidra (full)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Yoga nidra (brief)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Yoga 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.

Intervention Type: BEHAVIORAL

Yoga 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

iRest; iRest

Eligibility Criteria

Inclusion Criteria

• Endorses experiencing at least one lifetime very stressful or traumatic event that still distresses them
• 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
• 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
• Currently receiving or seeking treatment for alcoholism or a substance abuse disorder

Exclusion Criteria

• History of schizophrenia, psychotic disorder, or bipolar disorder
• Current endorsement of suicidality (score of 2 or higher on Item 9 of the BDI-II)
• Currently receiving psychological treatment for any mental health disorder
• Current diagnosis of any sleep disorder, excluding insomnia or nightmare disorder
• Currently taking benzodiazepines, nonbenzodiazepine receptor agonists, orexin agonists or antagonists, antiseizure medication, any medications for sleep
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunjeev Kamboj, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

University College London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Emily Mantaro

Role: CONTACT

emily.mantaro.23@ucl.ac.uk

+44 203-108-7007

Facility Contacts

Emily Mantaro

Role: primary

emily.mantaro.23@ucl.ac.uk

Other Identifiers

ZIAMH002962

Identifier Type: NIH

Identifier Source: secondary_id

View Link

26303/002

Identifier Type: -

Identifier Source: org_study_id