Clinical trial NCT06888336: Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms
Official title: Yoga Nidra Meditation for Insomnia and Posttraumatic Stress Symptoms: A Randomized-Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Insomnia
Stressor, Psychological
Psychological Trauma
Keywords: randomized controlled trial
meditation
PTSD
insomnia
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm parallel assignment
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility: Participant Retention
timeFrame: From baseline to follow-up (Weeks 1-10, Week 10, Week 18)
measure: Feasibility: Adherence to Yoga Nidra Protocol
timeFrame: Throughout treatment (Week 2 to 10)
Secondary outcomes:
measure: Sleep Characteristics, Assessed in the At-home PSG
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Daily Sleep Characteristics
timeFrame: From baseline to end of treatment/waitlist period (Weeks 1 to 10)
measure: Daily PTSD Symptom Severity
timeFrame: From baseline to end of treatment/waitlist period (Weeks 1 to 10)
measure: PTSD Symptoms (PCL-5)
timeFrame: Change from baseline to end of treatment and follow-up (Week 2; 10; 18)
measure: Insomnia Symptoms (ISI)
timeFrame: Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)
measure: Mindfulness (FFMQ-15)
timeFrame: Change from baseline to end of treatment and follow-up (Week 2; Week 10; Week 18)
measure: Acceptability of Intervention (CSQ)
timeFrame: Post-treatment (Week 10)
measure: Acceptability Ratings of Daily Surveys
timeFrame: Post-treatment/waitlist (Week 10)
Other outcomes:
measure: Experiential Avoidance (BEAQ)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Nightmare Disorder Symptom Severity (NDI)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Sleep Quality (PSQI)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Emotion Regulation (ERQ-9)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Self-Compassion (SOCS-S)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Depressive Symptoms (BDI-II)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Anxiety Symptoms (STAI)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Qualitative Feedback
timeFrame: Post-treatment (Week 10)
measure: Daily Intrusive Memories
timeFrame: From baseline to end of treatment/waitlist period (Weeks 1 to 10)
measure: Mindfulness Practice Quality (PQ-M)
timeFrame: Throughout treatment (Weeks 2 to 10)
measure: Heart Rate Variability (HRV)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
measure: Skin Conductance Level (SCL)
timeFrame: Change from baseline to post-treatment (Week 2; Week 10)
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Sunjeev Kamboj, PhD
role: PRINCIPAL_INVESTIGATOR
References: