Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms

Not Applicable

Recruiting

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

• Registration Number: NCT06888336
• Lead Sponsor: University College, London

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: Participant Retention	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	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Characteristics, Assessed in the At-home PSG	Change from baseline to post-treatment (Week 2; Week 10)	At-home polysomnography will be used to measure sleep architecture. Sleep characteristics of interest include N3 percentage, Sleep onset latency, Wake after sleep onset time, Total sleep time, Sleep spindles, and REM theta.
Daily Sleep Characteristics	From baseline to end of treatment/waitlist period (Weeks 1 to 10)	This will be assessed using the Consensus Sleep Diary - E, with an additional question administered in the morning to record number of nightmares experienced. Daily sleep characteristics will include: total sleep time, sleep onset latency, wake after sleep onset time, and number of nightmares.
Daily PTSD Symptom Severity	From baseline to end of treatment/waitlist period (Weeks 1 to 10)	A daily version of the PCL-5 8-item version will be administered each day, for participants to complete shortly before going to bed. The PCL-5 8-item version is an abbreviated version of the full-length PCL-5, with 2 symptoms assessed for each symptom cluster and ratings on a 5-point Likert scale (0 = Not at all bothered, 4 = Very bothered).
PTSD Symptoms (PCL-5)	Change from baseline to end of treatment and follow-up (Week 2; 10; 18)	The PTSD Checklist for the DSM-5 (PCL-5) is a self-report questionnaire used to assess severity of DSM-5 PTSD symptoms over the past month. It includes 20 items (5 per symptom cluster), each rated on a 5-point Likert scale (0 = Not at all bothered by, 4 = Extremely bothered by).
Insomnia Symptoms (ISI)	Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)	The Insomnia Severity Index (ISI) is a 7-item questionnaires that assesses the severity of daytime and nighttime components of insomnia over the past two weeks. A 5-point Likert scale (0 = No problem, 4 = Very severe problem) is provided for each item, and scores range from 0 to 28, with higher scores indicating greater insomnia severity.
Mindfulness (FFMQ-15)	Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)	The Five Facet Mindfulness Questionnaire, 15-item version (FFMQ-15) assesses five facets of mindfulness (Observing, Describing, Acting with Awareness, Nonjudging of Inner Experience, Nonreactivity to Inner Experience). Each item is rated from 1 to 5 ( 1 = Never or very rarely true; 5 = Very often or always true) according to what is generally true for the respondent, and there are 7 reverse-scored items. For all FFMQ-15 subscales, scores range from 3 to 15, with higher scores indicating greater mindfulness.
Acceptability of Intervention (CSQ)	Post-treatment (Week 10)	The Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item measure of satisfaction with a treatment. Each item is rated on a 4-point Likert scale, in which "1" indicates the lowest level of satisfaction and "4" indicates the highest level of satisfaction.
Acceptability Ratings of Daily Surveys	Post-treatment/waitlist (Week 10)	At conclusion of the daily monitoring period (Post-treatment/waitlist or Dropout), participants will respond to 10 questions intended to assess daily survey acceptability on a 7-point Likert scale (1 = Strongly Disagree; 7 = Strongly Agree) (adapted from Mintz et al., 2024).

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom