None listed
Conditions
Brief summary
This feasibility study aims investigate the value of a sleep quality program in people with low back pain and insomnia. The specific aims of this study are to investigate: (1) the rate of recruitment of adult twins registered at the Australian Twin Registry (ATR) with LBP to participate in the trial, (2) the feasibility of data collection and outcome measure completion, (3) contamination of intervention among twins, (4) acceptability and experience of the intervention, and (5) the sample size required for the full trial.
Interventions
Participants allocated to the intervention group will receive a web-based cognitive behavioral therapy (CBT) course comprised of six online sessions, once per week, delivered by an animated personal therapist (avatar), with automated web and email support developed by Sleepio limited (see www.sleepio.com/research). Each session has a minimum duration of 20 minutes. In this web-based program, underlying algorithms feed the delivery of information, support, and advice in a personally tailored mann
Participants allocated to the intervention group will receive a web-based cognitive behavioral therapy (CBT) course comprised of six online sessions, once per week, delivered by an animated personal therapist (avatar), with automated web and email support developed by Sleepio limited (see www.sleepio.com/research). Each session has a minimum duration of 20 minutes. In this web-based program, underlying algorithms feed the delivery of information, support, and advice in a personally tailored manner. The CBT content is consistent with the literature and covers behavioural (eg sleep restriction, stimulus control) and cognitive (eg thought re-structuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies. It also includes additional relaxation strategies and advice on lifestyle and bedroom factors (sleep hygiene). Participants will have access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users will also be able to participate in a moderated social network/community of users. All web-based interactions from the participants in the web-based CBT course will be electronically stored and participation activity will be assessed. We will record the following information: diary entries, session activities, engagement with the community, adherence to tasks.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Twin Population: Complete monozygotic or dizygotic twin pairs, with current email address in the Australian Twin Registry (ATR) database, with concomitant chronic low back pain (longer than 6 weeks) and symptoms of insomnia, and having current access to the internet with a device with speaker, such as computer or tablet. General Population People with concomitant chronic low back pain (longer than 6 weeks) and symptoms of insomnia, and having current access to the internet with a device with speaker, such as computer or tablet.
Exclusion criteria
Known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder), spinal surgery in past 12 months, current use of medication or any other treatment for insomnia or for depression, pregnant or lactating women, severe or extremely severe symptoms of depression, being in “poor” or “very poor” physical or mental health (self-report), presence of substance use disorder (self-report), shift worker, exceeding a threshold for other sleep disorder, unknown zygosity.
Outcome results
None listed