Impact of insomnia treatment on mood, brain function and cardiovascular health
| ISRCTN | ISRCTN13983243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13983243 |
| Secondary identifying numbers | Not applicable |
- Submission date
- 06/08/2018
- Registration date
- 13/08/2018
- Last edited
- 27/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Individuals with chronic insomnia have persistent difficulty falling and staying asleep, as well as complaints of difficulty thinking, concentrating, and remembering. Individuals with insomnia have an overactivation of certain bodily systems and increased negative emotional states. The overactivation of bodily systems can be evaluated using heart rate variability, the fluctuations in time differences between heartbeats as well as with sleep spindles, which are specific brain waves produced during sleep. Negative emotional states can be assessed using questionnaires on current mood and stress. The overactivation of certain bodily systems and increased negative emotional states have been proposed as both a cause and consequence of chronic insomnia.
This study aims to look at whether a psychological treatment for insomnia will reduce physiological and emotional overactivation, or whether bodily and emotional overactivation before treatment will reduce the efficacy of the psychological treatment for insomnia. This study also aims to assess whether the psychological treatment for insomnia will improve concentration and memory, and whether bodily overactivation at baseline will be associated with less improvement in sleep quality and thinking abilities after the psychological treatment for insomnia.
Who can participate?
Adults who suffer from chronic insomnia
What does the study involve?
Participants will first complete a pre-treatment assessment of their sleep, mood, stress, and bodily functions. Participants will sleep at our laboratory for one night, where their blood pressure, heart rate, and brain waves will be recorded at night and during the day. Blood and saliva samples will also be collected. Participants will wear a watch-like device to record their activity during 14 days in a row. Participants will also complete questionnaires and interviews about sleep, stress, and mood. After the completion of this initial assessment, participants will be assigned either to an 8-week group cognitive-behavioural therapy for insomnia or an 8-week waiting period. Following the completion of therapy or waiting period, participants will complete the same assessment of sleep, mood, and bodily function that they did before treatment. This assessment will also be repeated 12 months after the completion of the group therapy. Participants initially assigned to the waiting period will receive the group therapy after the completion of the post-waiting period assessment.
What are the possible benefits and risks of participating?
The possible benefit of participating in this study that participants may experience fewer insomnia symptoms and improved sleep quality as a result of the group therapy. The possible risks of participating are that the sensors used for assessment of bodily function may cause minor skin irritation, and the minor risk of pain and infection from taking blood samples.
Where is the study run from?
Concordia University, Montreal, Canada
When is the study starting and how long is it expected to run for?
December 2015 to January 2019
Who is funding the study?
Canadian Institutes for Health Research (Canada)
Who is the main contact?
Florence Pomares
insomnia.concordia@gmail.com
Contact information
Scientific
Concordia University
7141, Sherbrooke St. West, PY170-14
Montreal
H4B 1R6
Canada
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Physiological and emotional hyperarousal in chronic insomnia, and their relationships with insomnia treatment: a randomized controlled trial of cognitive-behavioural therapy for insomnia versus waitlist in participants with chronic insomnia |
| Study hypothesis | Greater physiological arousal at pre-treatment will be associated with less reduction in insomnia symptoms following cognitive-behavioural therapy for insomnia. Participants with higher spindle density will show larger decrease in insomnia symptoms and greater improvement in cognitive functioning after cognitive-behavioural treatment for insomnia. Cognitive-behavioural therapy for insomnia will lead to a significant reduction in emotional arousal. |
| Ethics approval(s) | Concordia University Human Research Ethics Committee, 17/12/2015, 30005506 |
| Condition | Chronic insomnia |
| Intervention | Participants are randomised into 2 groups, either the cognitive-behavioural therapy (CBT) group or a waiting list control group, in a 1:1 allocation ratio. Randomisation is conducted with block sizes of 4 participants. Randomisation results are contained in sealed opaque envelopes that are opened in the presence of the participants after the completion of the pre-treatment assessment. Participants in the cognitive behavioural therapy group will receive manual CBT therapy for insomnia. In groups of 4-8 participants, CBT therapy will involve 8 weekly, 90 minute meetings involving psychoeducation about sleep and circadian rhythms, stimulus control, sleep restriction, relaxation and cognitive therapy. Participants assigned to the waiting list control group will receive CBT therapy 3 months later, after completion of their post-waiting period assessment. A 12 month follow up assessment will be conducted 12 months after the completion of the post-treatment assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | The following are assessed at the baseline, post-treatment/post-waiting period and 12 month follow up: 1. Self-reported insomnia symptoms, assessed using the following, both of which are completed using online questionnaires: 1.1. Insomnia Severity Index (ISI) 1.2. 14-day sleep diary (sleep efficacy measure) based on the Consensus Sleep Diary 2. Physiological hyperarousal, assessed using the following: 2.1. Heart rate variability, measured using electrocardiogram leads 2.2. Sleep spindles, measured using electroencephalography leads during polysomnography 3. Emotional hyperarousal, assessed using the UCLA Life Stress Interview and a daily stress diary, completed conjointly with the sleep diary (1.2.) |
| Secondary outcome measures | 1. Total sleep time, assessed using the Consensus Sleep Diary and actigraphy with an accelerometer over 14 consecutive days at the baseline, post-treatment/post-waiting period and 12 month follow up 2. Sleep latency, assessed using the Consensus Sleep Diary and actigraphy with an accelerometer over 14 consecutive days at the baseline, post-treatment/post-waiting period and 12 month follow up 3. Duration of wake-after-sleep-onset (WASO), assessed using the Consensus Sleep Diary and actigraphy with an accelerometer over 14 consecutive days at the baseline, post-treatment/post-waiting period and 12 month follow up 4. Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) at the baseline, post-treatment/post-waiting period and 12 month follow up 5. Fatigue severity, assessed using the Fatigue Symptoms Inventory at the baseline, post-treatment/post-waiting period and 12 month follow up 6. Health-related quality of life, assessed using the 36-Item Short Form Survey (SF-36) at the baseline, post-treatment/post-waiting period and 12 month follow up 7. Presence of an insomnia disorder, assessed through a diagnostic interview with a trained interviewer using the Structured Clinical Interview for DSM-5 (SCID-V) at the baseline, post-treatment/post-waiting period and 12 month follow up 8. Polysomnography (PSG) measures, assessed at the baseline, post-treatment/post-waiting period and 12 month follow up: 8.1. PSG-derived sleep efficacy 8.2. Total sleep time 8.3. WASO 8.4. Sleep latency 8.5. Durations of sleep stages N1, N2, N3 and REM 9. Markers of physiological arousal: 9.1. Blood pressure, assessed using oscillometer measurements of systolic and diastolic blood pressure in the morning following overnight polysomnography 9.2. Cortisol levels, assessed using salivary samples collected at awakening, 30 minutes after awakening, at 4pm, and at bedtime for 2 consecutive days following overnight polysomnography 9.3. Plasma inflammatory markers, collected using antecubital venipuncture at the baseline, post-treatment/post-waiting period and 12 month follow up: 9.3.1. Interleukin-6 (IL-6) 9.3.2. Tumour necrosis factor alpha (TNFα) 9.3.3. C-reactive protein (CRP) 10. Markers of emotional arousal, assessed using online self-reported questionnaires at the baseline, post-treatment/post-waiting period and 12 month follow up: 10.1. Beck Depression Inventory (BDI) 10.2. State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) 10.3. Impact of Events Scale (IES-R) 10.4. Penn State Worry Questionnaire (PSWQ) 10.5. Gross Emotion Regulation Questionnaire (GERQ) 10.6. Behavioural Avoidance and Inhibition Scale (BIS/BAS) 11. Cognitive functioning, assessed using computerised N-back and Attention Network Tasks the morning following the overnight polysomnography at the baseline, post-treatment/post-waiting period and 12 month follow up |
| Overall study start date | 17/12/2015 |
| Overall study end date | 14/07/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Meeting diagnostic criteria for chronic insomnia for at least 6 months 2. Aged 18 years or older |
| Participant exclusion criteria | 1. Current neurological disorder 2. Past history of brain lesion 3. Major surgery requiring general anaesthesia in the past 3 months 4. Untreated thyroid disorder 5. Chronic pain syndrome self-reported as interfering with sleep 6. Recent and severe infection in the past 3 months (e.g. pneumonia, kidney infection) 7. Active cancer or treated cancer with post-cancer treatment for less than 2 years 8. Stroke 9. Myocardial infarction 10. Arterial bypass or angioplasty (e.g. coronary, carotid, femoral) 11. Pacemaker 12. Heart failure causing limitation of ordinary physical activity 13. Renal insufficiency 14. Sleep apnea with an apnea-hypopnea index greater than 15/h 15. Restless legs syndrome with symptoms occurring on 3 or more days per week (based on Restless Legs Syndrome Rating Scale) 16. Periodic limb movements during sleep with index greater than 15/h during polysomnography 17. REM sleep behaviour disorder with more than 1 episode per month (based on polysomnography) 18. Narcolepsy with cataplexy (based on Ullanlinna Narcolepsy Scale) 19. Sleepwalking more than once per month 20. Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months, or expecting to do so during the study period 21. Poor cognitive function (diagnosed with dementia and/or Montreal Cognitive Assessment (MoCA) less than 26) 22. Severe mental disorders: 22.1. Type I bipolar disorder 22.2. Schizophrenia 22.3. Anxiety disorders other than generalised anxiety disorder, except if associated with major depressive disorder (MDD) 22.4. Current substance use disorder 22.5. Current post-traumatic stress disorder 23. Current suicidality 24. Frequency alcohol consumption (more than 10 glasses per week) 25. Use of illicit drugs (more than once per month) 26. Pregnant or breastfeeding 27. Current psychotherapy or past cognitive behavioural therapy for insomnia 28. Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment |
| Recruitment start date | 02/11/2016 |
| Recruitment end date | 15/10/2018 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal
H4B 1R6
Canada
Sponsor information
University/education
Concordia University
7141, Sherbrooke St. West
Montreal
H4B 1R6
Canada
"ROR" |
https://ror.org/0420zvk78 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 15/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results of the main study hypotheses will be published in sleep and psychology journals in the two years following the completion of the trial. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Jean-Philippe Gouin, Ph.D. (jp.gouin@concordia.ca). Anonymized, processed data will be available on 01/01/2021 for replication analysis and meta-analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2022 | 27/09/2022 | Yes | No |
Editorial Notes
27/09/2022: Publication reference added.
21/01/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/12/2019 to 14/07/2020 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/03/2020 to 15/09/2022.
