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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CBT-pI
BehavioralA digital CBT-pI program co-developed with lived experts with a history of post-concussion insomnia and inspired from published recommendations and existing evidence-based CBT-pI programs.
Sleep Hygiene
BehavioralThis condition will leverage a digital sleep hygiene program that will mirror the CBT-I intervention
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioural Therapy for InsomniaActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in insomnia symptoms
Changes in insomnia symptoms as indicated by the Insomnia Severity Index-7 (ISI-7) total score from pre-intervention to post-intervention. The ISI-7 is a 7 item questionnaire with total scores ranging from 0 to 28, with higher scores indicating more severe insomnia symptoms.
Time frame
From baseline (week 0) to post-intervention (week 10)Secondary outcomes
1
Satisfaction with treatment effectiveness as measured with the Modified Treatment Satisfaction Questionnaire for Medication
Satisfaction with treatment effectiveness, side effects, and convenience as rated on the Modified Treatment Satisfaction Questionnaire for Medication (mTSQM). The TSQM is a 14-item self-report scale with total scores ranging from 14-98, higher scores indicating greater treatment satisfaction. This questionnaire has been adapted for the purpose of this study: the term "medication" has been replaced by "intervention", and the term "condition" had been replaced by "symptoms of insomnia or depression".
Time frame
10 weeks2
Satisfaction with treatment effectiveness as measured by the Modified Treatment Satisfaction Scale
Perceived perceived symptom improvements as well as overall treatment satisfaction as measured by the Modified Treatment Satisfaction Scale (TSS). The TSS is a 7 item questionnaire with total scores ranging from 7 to 35, with higher scores indicating greater treatment satisfaction. In the present study, the TSS was adapted for insomnia to measure symptom improvement in key areas including insomnia, energy level, work productivity, coping, life enjoyment, hopefulness, self-esteem, and mood.
Time frame
10 weeks3
Changes in insomnia symptoms
Changes in insomnia symptoms as indicated by the Insomnia Severity Index-7 (ISI-7) total score from pre-intervention to the first follow-up time point after the end of the intervention. The ISI-7 is a 7 item questionnaire with total scores ranging from 0 to 28, with higher scores indicating more severe insomnia symptoms.
Time frame
From baseline (week 0) to the first follow-up (week 14)4
Changes in insomnia symptoms
Changes in insomnia symptoms as indicated by the Insomnia Severity Index-7 (ISI-7) total score from pre-intervention to the last follow-up time point after the end of the intervention. The ISI-7 is a 7 item questionnaire with total scores ranging from 0 to 28, with higher scores indicating more severe insomnia symptoms.
Time frame
From baseline (week 0) to the last follow-up (week 34)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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