A Digital Cognitive Behavioural Therapy for Insomnia Intervention in Mild Cognitive Impairment and Mild Dementia

NCT07363928 | Completed

• 1 other identifier: 24079
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility of conducting a definitive randomised controlled trial that will determine the effectiveness of a digital cognitive behavioural therapy for insomnia intervention (Sleepio) in improving sleep, psychosocial health and cognitive performance in people with Mild Cognitive Impairment or mild dementia and co-morbid sleep disturbance.

Conditions

Dementia; Insomnia; Mild Cognitive Impairment; Sleep

Keywords

Digital cognitive behavioural therapy for insomnia; dementia; mild cognitive impairment; insomnia; sleep

Outcome Measures

Primary Outcomes (4)

• Participant Recruitment

  The aim of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess recruitment of the target number of 30 eligible participants during the six-month study period.

  Six Month Study Period

• Participant Retention

  The purpose of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess retention of the target number of 70% of enrolled participants throughout the study period.

  Six Month Study Period

• Participant Adherence

  The purpose of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess whether participants allocated to the intervention group achieve the target of 66% adherence to the intervention, defined as completion of four out of the six sessions involved in the intervention programme.

  Six Month Study Period

• Acceptability of the Intervention

  The purpose of this study is to assess the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess the acceptability of the intervention among the study population using a bespoke questionnaire incorporating the System Usability Scale adapted for cognitive impairment (targeting \>70% participants allocated to the intervention group scoring \>70/100) and the Usability Metric for User Experience - Lite (UMUX -Lite). The System Usability Scale is a validated and commonly employed 10-item Likert-type scale that provides a global assessment of how user-friendly a system or product is perceived to be. The UMUX-Lite is a more condensed 2-item Likert-type scale that also measures user-satisfaction with a system or product.

  Six Month Study Period

Secondary Outcomes (11)

• Sleep - Insomnia Severity Index (ISI)

  Baseline (enrollment) and 10 weeks post-enrollment

• Sleep - Sleep Condition Indicator (SCI)

  Baseline (enrollment) and 10 weeks post-enrollment

• Psychosocial Health - Patient Health Questionnaire 8 (PHQ-8)

  Baseline (enrollment) and 10 weeks post-enrollment

• Psychosocial Health - Generalised Anxiety Disorder 7 (GAD-7),

  Baseline (enrollment) and 10 weeks post-enrollment

• Psychosocial Health - Euroqol EQ 5D Visual Analogue Scale

  Baseline (enrollment) and 10 weeks post-enrollment

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants allocated to the intervention group will be provided with access to Sleepio, a fully-automated digital cognitive behavioural therapy for insomnia programme designed to treat insomnia using a combination of evidence-based cognitive and behavioural techniques. Underlying algorithms organise the delivery of information, support, and advice in a manner tailored to each individual participant based on their responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme. The Sleepio programme consists of six sessions, each ranging from five-to twenty minutes in duration. After the first session, each subsequent session is 'unlocked' one week after delivery of the prior session. Accordingly, the programme can be completed within a six-week period. However, the average time taken to complete the programme is 9-10 weeks.

Other: Digital cognitive behavioural therapy for insomnia

Control Group

NO INTERVENTION

Participants allocated to the control group will continue to receive 'treatment-as-usual' throughout the duration of the study period. They will be informed that they will be provided with access to the intervention at the end of the study period.

Interventions

Digital cognitive behavioural therapy for insomnia OTHER

Sleepio is a digital cognitive behavioural therapy for insomnia programme designed to treat insomnia by relying on underlying algorithms to tailor delivery of evidence-based cognitive and behavioural techniques based on participants' responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme.

Intervention Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 years.
• Sleep Condition Indicator Score ≤16/32.
• Established Mild Cognitive Impairment (MCI) or mild dementia, diagnosed by a consultant physician specialised in cognitive disorders prior to enrolment in the study. Dementia will be defined using DSM-5 classification and staged according to the Reisberg FAST scale into early/mild stage (Stages 1-4). MCI will be defined using Petersen's criteria. To participate those with MCI/mild dementia must score:
• ≥18 on the Mini-Mental State Examination (MMSE), and
• ≥0.5-1.0 on the Clinical Dementia Rating (CDR) scale.
• Internet access for the duration of the intervention (via computer/tablet/smartphone).
• Sufficient physical/sensory (visual/hearing) capacity to use the intervention, as judged by the clinician/investigator.
• English-speaker (intervention only available in English).
• Community-dwellers (non-institutionalised).

You may not qualify if:

• Known history of an International Classification of Diseases (ICD) defined sleep disorder other than insomnia disorder.
• Receipt of a sleep-related cognitive behavioural therapy (CBT) intervention within the past six months.
• MMSE score \<18 at enrolment, to facilitate adherence and ensure recruitment of those with mild-stage disease.
• Severe depression (defined as depression requiring hospitalisation in the past 12-months or visit to psychiatry outpatient clinic in the past 3 months).
• Unstable depression/anxiety disorders or panic attacks (unstable will be defined as changes in antidepressant medications within the last 3 months, i.e. no start, stop or change in dose).
• Other relevant major neuropsychiatric disorders, including schizophrenia, psychosis, mania, bipolar affective disorder, epilepsy or seizure disorder.
• Ongoing substance or alcohol abuse.
• Long-term physical or sensory impairment, pain or other medical condition which, in the opinion of the principal investigator, could impair participation for reasons other than cognitive impairment.
• Planned surgery or hospitalisation during the study that could interfere with participation.
• Medical conditions rendering the patient too unwell to continue to participate in the study in the opinion of the principal investigator.
• A change in the following medication within the three months prior to enrolment:
• Benzodiazepine and non-benzodiazepine hypnotic or anxiolytics agents
• Cholinesterase inhibitors or Memantine
• Antidepressants
• Antipsychotics

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Mercy University Hospital

Cork, Ireland

Location

Related Publications (15)

• Tarnai K, Henry A, Miller C, Waxmonsky J, Emsley R, Espie C. 0352 Digital cognitive behavioral therapy in treating insomnia in older adulthood: A sub-analysis using individual participant data. Sleep. 2023;46(Supplement_1):A156-A.

  BACKGROUND

• Kyle SD, Hurry MED, Emsley R, Marsden A, Omlin X, Juss A, Spiegelhalder K, Bisdounis L, Luik AI, Espie CA, Sexton CE. The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial. Sleep. 2020 Sep 14;43(9):zsaa034. doi: 10.1093/sleep/zsaa034.

  PMID: 32128593 BACKGROUND

• Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.

  PMID: 22654196 BACKGROUND

• Espie CA, Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, Cape J, Ong JC, Sheaves B, Foster R, Freeman D, Costa-Font J, Marsden A, Luik AI. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Jan 1;76(1):21-30. doi: 10.1001/jamapsychiatry.2018.2745.

  PMID: 30264137 BACKGROUND

• Hoyos C, Espinosa N, Marshall N, LaMonica H, Gordon C, Rainey-Smith S, et al. 0441 Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED). Sleep. 2024;47(Supplement_1):A189-A.

  BACKGROUND

• Mattos MK, Manning CA, Quigg M, Davis EM, Barnes L, Sollinger A, Eckstein M, Ritterband LM. Feasibility and Preliminary Efficacy of an Internet-Delivered Intervention for Insomnia in Individuals with Mild Cognitive Impairment. J Alzheimers Dis. 2021;84(4):1539-1550. doi: 10.3233/JAD-210657.

  PMID: 34690141 BACKGROUND

• Lee Y, Kim I, Lee S, Yu S. Information and Communication Technology-Based Application for Cognitive Behavioral Therapy among Community-Dwelling Older Adults with Insomnia: Development and Validation Study. Healthcare (Basel). 2024 Jan 2;12(1):106. doi: 10.3390/healthcare12010106.

  PMID: 38201011 BACKGROUND

• Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.

  PMID: 26615572 BACKGROUND

• Soh HL, Ho RC, Ho CS, Tam WW. Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. Sleep Med. 2020 Nov;75:315-325. doi: 10.1016/j.sleep.2020.08.020. Epub 2020 Aug 26.

  PMID: 32950013 BACKGROUND

• Koffel E, Kuhn E, Petsoulis N, Erbes CR, Anders S, Hoffman JE, Ruzek JI, Polusny MA. A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia. Health Informatics J. 2018 Mar;24(1):3-13. doi: 10.1177/1460458216656472. Epub 2016 Jun 27.

  PMID: 27354394 BACKGROUND

• Naismith SL, Pye J, Terpening Z, Lewis S, Bartlett D. "Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Behav Sleep Med. 2019 Nov-Dec;17(6):778-789. doi: 10.1080/15402002.2018.1518223. Epub 2018 Sep 24.

  PMID: 30247939 BACKGROUND

• Cassidy-Eagle E, Siebern A, Unti L, Glassman J, O'Hara R. Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Clin Gerontol. 2018 Mar-Apr;41(2):136-144. doi: 10.1080/07317115.2017.1384777. Epub 2017 Dec 8.

  PMID: 29220627 BACKGROUND

• Crowley P, O'Donovan MR, Leahy P, Flanagan E, O'Caoimh R. Pharmacological and Non-Pharmacological Interventions to Improve Sleep in People with Cognitive Impairment: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2025 Jun 18;22(6):956. doi: 10.3390/ijerph22060956.

  PMID: 40566383 BACKGROUND

• Riemann D, Espie CA, Altena E, Arnardottir ES, Baglioni C, Bassetti CLA, Bastien C, Berzina N, Bjorvatn B, Dikeos D, Dolenc Groselj L, Ellis JG, Garcia-Borreguero D, Geoffroy PA, Gjerstad M, Goncalves M, Hertenstein E, Hoedlmoser K, Hion T, Holzinger B, Janku K, Jansson-Frojmark M, Jarnefelt H, Jernelov S, Jennum PJ, Khachatryan S, Krone L, Kyle SD, Lancee J, Leger D, Lupusor A, Marques DR, Nissen C, Palagini L, Paunio T, Perogamvros L, Pevernagie D, Schabus M, Shochat T, Szentkiralyi A, Van Someren E, van Straten A, Wichniak A, Verbraecken J, Spiegelhalder K. The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023. J Sleep Res. 2023 Dec;32(6):e14035. doi: 10.1111/jsr.14035.

  PMID: 38016484 BACKGROUND

• Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986.

  PMID: 33164742 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Rónán O'Caoimh, PhD

  Mercy University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: REST is an investigator-blinded, randomised, controlled, two arm, parallel, feasibility study. Participants will be randomised to intervention versus true wait-list control in a 1:1 ratio using a centrally administered, computer-generated randomisation scheme. An asymptotic maximal randomisation strategy, with a maximum tolerated imbalance of three, will be employed. Participants allocated to the intervention group will undertake the digital cognitive behavioural therapy programme (Sleepio). The study co-ordinator will be unblinded to study group assignment in order to facilitate provision of training regarding use of the intervention to those participants assigned to the intervention group. Site investigators, data collectors and statisticians will remain blinded to study group assignment.

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 23, 2026
• Study Start: January 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)