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Posttraumatic Stress Disorder (PTSD)NCT06888336

Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms

A study testing Yoga nidra (full) and Yoga nidra (brief) in people with Posttraumatic Stress Disorder (PTSD) and Insomnia, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
Yoga nidra (full) and Yoga nidra (brief)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
3 Mar 2025to 17 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University College London

    London

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Yoga nidra (full), Yoga nidra (brief)
Keywords
randomized controlled trial, meditation, PTSD, insomnia
Medical subject headings
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Stress, Psychological, Psychological Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga nidra (full)Behavioural

    Also called iRest

    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 (brief)Behavioural

    Also called iRest

    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.

Study groups in NCT06888336
Study groupRoleWhat they receive
Yoga nidra (30 minutes each day)ExperimentalParticipants will listen to ~30-minute yoga nidra meditation recordings every day for 8 weeks.
Receives: Behavioral: Yoga nidra (full)
Yoga nidra (one 30-minute session/week, six 10-minute sessions/week)ExperimentalFor 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.
Receives: Behavioral: Yoga nidra (brief)
Waitlist ControlNo interventionDuring 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Participant Retention

    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.

    Measured: From baseline to follow-up (Weeks 1-10, Week 10, Week 18)

  2. Feasibility: Adherence to Yoga Nidra Protocol

    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.

    Measured: Throughout treatment (Week 2 to 10)

Secondary outcomes (8)
  1. Sleep Characteristics, Assessed in the At-home PSG

    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.

    Measured: Change from baseline to post-treatment (Week 2; Week 10)

  2. Daily Sleep Characteristics

    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.

    Measured: From baseline to end of treatment/waitlist period (Weeks 1 to 10)

  3. Daily PTSD Symptom Severity

    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).

    Measured: From baseline to end of treatment/waitlist period (Weeks 1 to 10)

  4. PTSD Symptoms (PCL-5)

    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).

    Measured: Change from baseline to end of treatment and follow-up (Week 2; 10; 18)

  5. Insomnia Symptoms (ISI)

    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.

    Measured: Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)

  6. Mindfulness (FFMQ-15)

    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.

    Measured: Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)

  7. Acceptability of Intervention (CSQ)

    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.

    Measured: Post-treatment (Week 10)

  8. Acceptability Ratings of Daily Surveys

    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).

    Measured: Post-treatment/waitlist (Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start3 Mar 2025
  3. Primary completion17 Mar 2026
  4. Study completion17 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three-arm parallel assignment
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06888336
Sponsor's protocol ID
26303/002
Other IDs
ZIAMH002962
Status last verified
May 2026
First submitted
6 Mar 2025
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified demographic, questionnaire, and physiological participant data will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Yoga nidra (full) and Yoga nidra (brief) in people with Posttraumatic Stress Disorder (PTSD) and Insomnia, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Participant Retention (time frame: From baseline to follow-up (Weeks 1-10, Week 10, Week 18)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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