Chronic Insomnia Treatment Using Virtual Reality (VR) Delivered Mindfulness

Not Applicable

Recruiting

Conditions: chronic insomnia
Mental Health - Other mental health disorders
Neurological - Other neurological disorders

Registration Number: ACTRN12623000892617

Lead Sponsor: niversity of Newcastle

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 43

Inclusion Criteria

1. Aged 18 - 80 years.
2. Proficient in reading, writing, and communicating in English.
3. Insomnia symptoms (difficulty falling asleep, staying asleep, or waking too early) at least 3 times per week for a minimum of 3 months and an Insomnia Severity Index (ISI) score greater than or equal to 10.
4. Able to attend an in-person baseline appointment.
5. Be willing to be randomised to VR or 2D (computer) delivered mindfulness.
6. Willing to use a VR headset to complete the twice weekly VR-delivered mindfulness sessions if randomised to the VR condition.

Exclusion Criteria

1. Unable to move the head in all directions and wear a VR head-mounted display
2. Vertigo or related conditions (e.g., Meniere's disease)
3. Unstable medication regimen, defined as having commenced, discontinued, or changed medication or its dosage within < 2 weeks
4. Substance use at a level or of a type likely to cause significant impairment, defined as a high score on the Alcohol Use Disorders Identification Test (AUDIT-C).
5. Admission to a psychiatric hospital within the last 12 months
6. Diagnosed severe psychiatric illness (e.g., Schizophrenia)
7. Thoughts of self-harm in the last 2 weeks, defined as Patient Health Questionnaire (PHQ -9) score >1 on question 9
8. Sleep disorder (other than insomnia) due to neurological or medical cause (e.g., parasomnias, OSA, narcolepsy, seizure) or prescribed sleep aid (e.g., CPAP)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion<br>% mindfulness sessions completed in 4 weeks of treatment<br>Participant mindfulness practice log.[ At the conclusion of 4 weeks of treatment from the completion of baseline measures. ]

Secondary Outcome Measures

Name	Time	Method
Treatment Satisfaction: Questionnaire<br>Treatment satisfaction is measured using a modified/adapted version of the Multi-Dimensional Treatment Satisfaction Measure (MDTSM) for insomnia.<br><br>The MDTSM consists of 11 subscales assessing the treatment process and outcome attributes. Each subscale has 1-8 items. Each question except the Discomfort subscale is rated on a five-point scale ranging from zero (Not at all”) to 4 (Very much”). The 33-item instrument was developed for behavioural interventions and is designed to provide a comprehensive set of treatment attributes.<br><br>Participant mean scores across all 33 ratings are calculated, resulting in a score ranging from zero (Not at all satisfied) to 4 (Very satisfied).[ Within 2 days after the final treatment session.]