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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06567210




Registration number
NCT06567210
Ethics application status
Date submitted
18/07/2024
Date registered
22/08/2024
Date last updated
22/08/2024

Titles & IDs
Public title
The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
Scientific 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
Secondary ID [1] 0 0
14308
Universal Trial Number (UTN)
Trial acronym
Restless
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Chronic 0 0
Depression, Anxiety 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - CBCTi
BEHAVIORAL - General sleep information

Experimental: CBCTi - 8-weeks online therapist-guided CBCTi including weekly online modules. Guidance is provided via scheduled and ad hoc communications (e.g., email, messaging, telehealth) between the participant and a clinician/physician

Active comparator: General sleep information - For 8 weeks, participants will receive assess to general sleep health information and perform daily sleep diaries.


BEHAVIORAL: CBCTi
The program is composed of weekly online modules that include written information and interactive components such as schematics, images, videos, and questions. The content of the modules follows traditional and validated cognitive-behavioural therapy for insomnia protocols including sleep education, behavioural strategies (e.g., stimulus control, bedtime retraining, sleep hygiene), cognitive restructuration approaches (e.g., thought reappraisal, imagery, mindfulness), and relaxation practices (progressive muscle relaxation and autogenic training). In addition, further content aims to stabilize and amplify circadian rhythmicity through light exposure in the morning, daytime moderate physical activity, and evening time warm baths. Participants complete daily sleep diaries throughout the intervention.

BEHAVIORAL: General sleep information
General sleep health information and access to daily sleep diaries during 8 weeks
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insomnia Severity Index (ISI) score
Timepoint [1] 0 0
8 weeks, 8 months, 20 months
Primary outcome [2] 0 0
Patient Health Questionnaire-9 (PHQ-9) score
Timepoint [2] 0 0
8 weeks, 8 months, 20 months
Primary outcome [3] 0 0
General Anxiety Disorder-7 (GAD-7) score
Timepoint [3] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [1] 0 0
EEG sleep efficiency (SE - %)
Timepoint [1] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [2] 0 0
EEG total sleep time (TST - minutes)
Timepoint [2] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [3] 0 0
EEG wake duration (minutes)
Timepoint [3] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [4] 0 0
EEG sleep onset latency (SOL - minutes)
Timepoint [4] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [5] 0 0
EEG sleep stages (%)
Timepoint [5] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [6] 0 0
Actigraphy sleep efficiency (%)
Timepoint [6] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [7] 0 0
Actigraphy total sleep duration (minutes)
Timepoint [7] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [8] 0 0
Actigraphy wake duration (minutes)
Timepoint [8] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [9] 0 0
Actigraphy sleep onset latency (minutes)
Timepoint [9] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [10] 0 0
7-days light exposure (lux)
Timepoint [10] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [11] 0 0
Hour of Dim-Light Melatonin Onset (HDLMO - hour)
Timepoint [11] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [12] 0 0
3-days distal-proximal skin-temperature gradients (DPG)
Timepoint [12] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [13] 0 0
Self-reported sleep duration (min)
Timepoint [13] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [14] 0 0
Self-reported wake duration (min)
Timepoint [14] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [15] 0 0
Self-reported sleep onset latency (min)
Timepoint [15] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [16] 0 0
Self-reported sleep quality (out of 5)
Timepoint [16] 0 0
8 weeks, 8 months, 20 months
Secondary outcome [17] 0 0
Sleep misperception index (SPI - %)
Timepoint [17] 0 0
8 weeks, 8 months, 20 months

Eligibility
Key inclusion criteria
* Diagnosis of insomnia disorder (DSM-V-TR) or ISI score = 10.
* All sexes and genders.
* Between 25 and 45 years of age.
* Able to provide informed consent.
* Proficient in English.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder, moderate to severe sleep apnoea disorder based on previous sleep study with an apnea-hypopnea index = 15 and/or STOP-BANG high-risk score and/or finger-pulse oximetry oxygen desaturation index (ODI) = 10).
* Any contradictions for MRI (e.g., claustrophobia, presence of metal in body, cochlear implants).
* Current or history of neurological disorders (e.g., stroke, brain injury).
* Current or history of any disorder listed in DSM-V other than major depression and anxiety disorders (post-traumatic stress disorder is excluded).
* Centrally active agents or presence of medical condition that may affect participation.
* Pregnancy or actively trying to conceive, or lactating.
* Shift work for at least 2 shifts per week in the past 3 months (i.e., work between 21:00 and 6:00).
* Travel across time zones over 3 hours difference in the previous 30 days (will require a 1-week adjustment period per hour of time zone travelled).
* Unwilling to know about potential incidental findings.
* No consent or adherence to instructions for any part of the study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2029
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Macquarie University, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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; N=82) versus control (N=27) on subjective and objective sleep and circadian measures as well as symptom and severity of depression and anxiety. The project will involve at-home assessments.Participants 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.
Trial website
https://clinicaltrials.gov/study/NCT06567210
Trial related presentations / publications
Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry. 2014 Apr;26(2):205-13. doi: 10.3109/09540261.2014.902808.
Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
Leerssen J, Lakbila-Kamal O, Dekkers LMS, Ikelaar SLC, Albers ACW, Blanken TF, Lancee J, van der Lande GJM, Maksimovic T, Mastenbroek SE, Reesen JE, van de Ven S, van der Zweerde T, Foster-Dingley JC, Van Someren EJW. Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial. Psychother Psychosom. 2022;91(3):168-179. doi: 10.1159/000520282. Epub 2021 Dec 6.
Christensen H, Batterham PJ, Gosling JA, Ritterband LM, Griffiths KM, Thorndike FP, Glozier N, O'Dea B, Hickie IB, Mackinnon AJ. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016 Apr;3(4):333-41. doi: 10.1016/S2215-0366(15)00536-2. Epub 2016 Jan 28. Erratum In: Lancet Psychiatry. 2016 Apr;3(4):320. doi: 10.1016/S2215-0366(16)30003-7.
Wassing R, Lakbila-Kamal O, Ramautar JR, Stoffers D, Schalkwijk F, Van Someren EJW. Restless REM Sleep Impedes Overnight Amygdala Adaptation. Curr Biol. 2019 Jul 22;29(14):2351-2358.e4. doi: 10.1016/j.cub.2019.06.034. Epub 2019 Jul 11.
Wassing R, Schalkwijk F, Lakbila-Kamal O, Ramautar JR, Stoffers D, Mutsaerts HJMM, Talamini LM, Van Someren EJW. Haunted by the past: old emotions remain salient in insomnia disorder. Brain. 2019 Jun 1;142(6):1783-1796. doi: 10.1093/brain/awz089.
Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344.
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
Berntsen D, Hoyle RH, Rubin DC. The Autobiographical Recollection Test (ART): A Measure of Individual Differences in Autobiographical Memory. J Appl Res Mem Cogn. 2019 Sep;8(3):305-318. doi: 10.1016/j.jarmac.2019.06.005. Epub 2019 Jul 26.
Public notes

Contacts
Principal investigator
Name 0 0
Rick Wassing, PhD
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rick Wassing, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 0298502663
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06567210