The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders

NCT06567210 | Recruiting

• 3 other identifiers: 14308227100/Z/23/ZGNT1196636
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to elucidate whether CBCTi changes symptom severity or even remission of anxiety disorders as compared with a delayed-start control group. The investigators will use a delayed-start randomized controlled trial in a cohort of individuals with anxiety and insomnia (N=98) to compare the effects of an online therapist-guided cognitive behavioural and circadian therapy for insomnia versus control on overnight emotion regulation and mental health outcomes. The project will involve at-home assessments and in-lab visits. At-home assessment involves recording sleep and circadian rhythm measures with wearables and daily diaries. Participants will be invited to perform two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.

Conditions

Insomnia Chronic; Anxiety

Keywords

insomnia; anxiety; online cognitive behavioral and circadian therapy for insomnia

Outcome Measures

Primary Outcomes (2)

• General Anxiety Disorder-7 (GAD-7) score

  Self-report measures of anxiety symptoms and severity. GAD-7 consists of 7 Likert-scale questions with a total score ranging from 0 to 21 (with higher scores indicating more severe anxiety)

  2 months, 4 months, 12 months

• Anxiety Disorder diagnosis

  Clinician-diagnosed anxiety disorder in accordance with the DSM-5-TR using the Mini-International Neuropsychiatric Interview

  2 months, 4 months, 12 months

Secondary Outcomes (18)

• Insomnia Severity Index (ISI) score

  2 months, 4 months, 12 months

• EEG sleep efficiency (SE - %)

  2 months, 4 months, 12 months

• EEG total sleep time (TST - minutes)

  2 months, 4 months, 12 months

• EEG wake duration (minutes)

  2 months, 4 months, 12 months

• EEG sleep onset latency (SOL - minutes)

  2 months, 4 months, 12 months

Other Outcomes (5)

• Sleep electroencephalographic (EEG) spectral power

  2 months

• Sleep electroencephalographic (EEG) neuro-oscillatory coupling

  2 months

• Functional connectivity patterns in resting-state brain networks

  2 months

Study Arms (2)

Immediate CBCTi

EXPERIMENTAL

Immediate 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

Behavioral: Immediate CBCTi

Delayed-start control

OTHER

Participants in the delayed-start control group will not receive any active intervention during two months but will be offered the same therapist-guided CBCTi program thereafter.

Behavioral: Delayed CBCTi

Interventions

Immediate CBCTi BEHAVIORAL

This intervention will be immediately accessible to the CBCTi group. 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.

Immediate CBCTi

Delayed CBCTi BEHAVIORAL

This intervention will be accessible after a waiting period of 2 months (i.e, delayed start). 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.

Delayed-start control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (A or B) and (C) A. Diagnosis of insomnia disorder (DSM-5-TR) B. Insomnia Severity Index (ISI) score ≥ 10 C. Generalized Anxiety Disorder (GAD-7) score ≥ 10
• All sexes and genders.
• Between 18 and 45 years of age.
• Able to provide informed consent.
• Proficient in English.

You may not qualify if:

• x 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 finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10).
• Current or history of neurological disorders (e.g., stroke, brain injury).
• Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder.
• Current uncontrolled mental health disorders requiring specialist care, other than major depression and anxiety disorders.
• 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-day 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.

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead
• Macquarie University, Australia: collaborator

Study Sites (1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, 2109, Australia

RECRUITING

Related Publications (10)

• 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.

  PMID: 30537570 BACKGROUND

• 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.

  PMID: 24892895 BACKGROUND

• 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.

  PMID: 28875581 BACKGROUND

• 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.

  PMID: 34872087 BACKGROUND

• 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.

  PMID: 26827250 BACKGROUND

• 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.

  PMID: 31303489 BACKGROUND

• 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.

  PMID: 31135050 BACKGROUND

• 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.

  PMID: 26414893 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

• 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.

  PMID: 31700775 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Rick Wassing, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Wassing, PhD

CONTACT

+61 0298502663; rick.wassing@woolcock.org.au

Aurore Perrault, PhD

CONTACT

aurore.perrault@mq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers responsible for randomization and data-analysis will be blinded to the study arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Delayed-start randomized controlled trial

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 22, 2024
• Study Start: January 6, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)