Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567210
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Parallel-group Randomized Controlled Trial Comparing the Effects of Online Therapist-guided Cognitive Behavioural and Circadian Therapy for Insomnia Versus Control on Emotional Regulation and Risk for Mental Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Restless
Brief Summary:
This project aims to understand and treat insomnia disorder to prevent depression and anxiety The investigators will use an experimental parallel two-arm repeated measures randomized controlled trial in a cohort of individuals with insomnia to compare the effects of online therapist-guided cognitive behavioural and circadian therapy for insomnia CBCTi N82 versus control N27 on subjective and objective sleep and circadian measures as well as symptom and severity of depression and anxiety The project will involve at-home assessmentsParticipants from the CBCTi group will also be invited for two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress
Detailed Description:
This study is a parallel-group randomized controlled trial comparing the effects of online therapist-guided cognitive behavioural and circadian therapy for insomnia CBCTi versus control on emotional regulation and risk for mental disorders
To be enrolled in the study the participants are required to complete an online prescreening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study After an interview screening the participants will receive a finger-pulse oximeter by mail to screen for the presence of obstructive sleep apnoea 3 nights at-home The device is then returned by pre-paid mail and the recording is analysed to screen for moderate to severe sleep apnoea oxygen desaturation index 10 If eligible the participant will be invited to the Woolcock Institute for a screening visit
The screening visit starts with a consult with a clinicianphysician who performs a medical screening explains the study answers questions and addresses concerns and obtains written informed consent At the end of the consult all eligibility criteria have been evaluated and eligible participants are assigned a randomization number ie allocated to either the CBCTi-arm or the control-arm The treatment arm consists of an online therapist-guided CBCTi intervention which comprises online sessions to be completed in 8 weeks The control arm in this study will consist of providing general sleep health information and access to daily sleep diaries
During the screening visit participants assigned to the CBCTi-arm will be asked to perform in an audio-visual recording while singing along to Waltzing Matilda karaoke style and asked to give keywords that relate to at least five negative distressing experiences and an equal number of neutral experiences from the same period The recording and the keywords will be used to derive the stimuli that are used in the functional MRI tasks T1 and T2 For both groups the screening visit is concluded with a demonstration on how to collect data at-home
Both groups will be asked to perform a week of at-home assessment during 4 timepoints T1 baseline T2 8-weeks post-baseline T3 8 months post-baseline and T4 20 months post-baseline During the week of at-home assessments the participants complete questionnaires keep a sleep diary and wear an actigraphy-watch and light and temperature sensor across 7 days They are also asked to complete at least four overnight polysomnographic recordings At T1 and T2 only they also complete a salivary melatonin collection protocol
Only the participants in the CBCTi arm complete additional in-lab assessments at T1 and T2 They are invited to Macquarie UniversityWoolcock Institute to undergo overnight sleep studies and neuroimaging sessions
The CBCTi program will be given online via secure platforms and recruitment will primarily be through social media advertisements The study will be coordinated from the Woolcock Institute of Medical Research Sydney Macquarie Park New South Wales 2109 Australia
To be enrolled in the study the participants are required to complete an online prescreening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study After an interview screening the participants will receive a finger-pulse oximeter by mail to screen for the presence of obstructive sleep apnoea 3 nights at-home The device is then returned by pre-paid mail and the recording is analysed to screen for moderate to severe sleep apnoea oxygen desaturation index 10 If eligible the participant will be invited to the Woolcock Institute for a screening visit
The screening visit starts with a consult with a clinicianphysician who performs a medical screening explains the study answers questions and addresses concerns and obtains written informed consent At the end of the consult all eligibility criteria have been evaluated and eligible participants are assigned a randomization number ie allocated to either the CBCTi-arm or the control-arm The treatment arm consists of an online therapist-guided CBCTi intervention which comprises online sessions to be completed in 8 weeks The control arm in this study will consist of providing general sleep health information and access to daily sleep diaries
During the screening visit participants assigned to the CBCTi-arm will be asked to perform in an audio-visual recording while singing along to Waltzing Matilda karaoke style and asked to give keywords that relate to at least five negative distressing experiences and an equal number of neutral experiences from the same period The recording and the keywords will be used to derive the stimuli that are used in the functional MRI tasks T1 and T2 For both groups the screening visit is concluded with a demonstration on how to collect data at-home
Both groups will be asked to perform a week of at-home assessment during 4 timepoints T1 baseline T2 8-weeks post-baseline T3 8 months post-baseline and T4 20 months post-baseline During the week of at-home assessments the participants complete questionnaires keep a sleep diary and wear an actigraphy-watch and light and temperature sensor across 7 days They are also asked to complete at least four overnight polysomnographic recordings At T1 and T2 only they also complete a salivary melatonin collection protocol
Only the participants in the CBCTi arm complete additional in-lab assessments at T1 and T2 They are invited to Macquarie UniversityWoolcock Institute to undergo overnight sleep studies and neuroimaging sessions
The CBCTi program will be given online via secure platforms and recruitment will primarily be through social media advertisements The study will be coordinated from the Woolcock Institute of Medical Research Sydney Macquarie Park New South Wales 2109 Australia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None