Post-Concussion Sleep and Brain-heart Functions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ottawa
About this trial
This project is designed as a randomized controlled trial (RCT), with an active control group. Sleep and heart rate will be monitored at home for 1 week before and after the intervention. Questionnaires will be completed from home before, during and 8 weeks after the end of the Intervention. The Cognitive Behavioural Therapy for Insomnia, adapted for post-concussed individuals (CBT-pI) and control interventions, will be delivered on a digital online platform over an 8-week period. Participants in the control arm will be offered CBT-pI after the follow-up period. All intervention arms will be delivered as adjuncts to standard clinical care. All other treatments received during the intervention will be documented.
Eligibility criteria
Qualifiers
Adults 18 years and older
Experiencing persisting post-concussion symptoms > 4 weeks but no more than 12 months post-injury as measured based on home-made screening questions and the Sport Concussion Assessment Tool (SCAT6)
Having a Sleep Condition Indicator score suggestive of insomnia (SCI =/< 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month)
Meeting diagnostic criteria for insomnia disorder on the SCID
Disqualifiers
Having undergone another CBT-I program within the past 6 months
Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I.
Self-reported substance use disorder (i.e., alcohol, cannabis, or illicit drugs) or =/> monthly use of illicit drugs reported on item-2 of the WHO-ASSIST (except tobacco, alcohol, and cannabis)
Body mass index > 45
Trial design
Treatments tested in this trial
- CBT-pI
- Sleep Hygiene
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov