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InsomniaSACSNCT05816460

The Sleepio After Cancer Study

A study testing Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) and Sleep Hygiene Education (SHE) in people with Insomnia and Cancer, run by University College Dublin at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Insomnia, Cancer
What is being tested?
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) and Sleep Hygiene Education (SHE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
1 siteIreland
Study dates
22 May 2023to 10 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women
  • Aged 18 and over
  • Sleep Condition Indicator (SCI) score of 16 or less
  • Current or past diagnosis of cancer
  • Fluent in written and spoken English
  • Internet access and comfortable with its use

Who cannot join

  • Acute Illness
  • Life expectancy less than 6 months
  • Evidence of another sleep disorder
  • Untreated Psychiatric Disorder
  • Drug Misuse
  • Currently receiving CBT for insomnia from a health professional or taking part in an online treatment programme for insomnia
Show all 9Show fewer
  • Any condition that may be exacerbated by sleep restriction therapy (Obstructive sleep apnoea, Bipolar disorder, psychosis, schizophrenia, epilepsy, current suicidal ideation, shift work, dementia, Parkinson's disease, Lewy body dementia)
  • Planned Major Surgery
  • Commencement or a change in sleep medication within the last 4 weeks

Trial locations and contacts

1 site in 1 country.

Donal Brennan, PhD contact

+353879577510

donal.brennan@ucd.ie

Teresa Treacy, MB, BCh, BAO contact

+353861606647

teresa.treacy@ucdconnect.ie

Ireland1 site

  • University College Dublin

    Dublin, D04V1W8

    Donal Brennan, PhD, +353879577510, donal.brennan@ucd.ie

    Teresa Treacy, MB, BCh, BAO, +353861606647, teresa.treacy@ucdconnect.ie

Other trials in Ireland

About this study

Official title: The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial

This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education.

Read the detailed description

Women who are eligible and provide informed consent will be enrolled into this 2-armed, parallel group open label randomised controlled trial. Participants will be randomised 1:1 to receive dCBT-I (intervention arm) or to sleep hygiene education (control arm). The primary outcome will be the mean continuous change in sleep condition indicator (SCI) score in the intervention arm compared to the control arm at 6 months. In addition to this, the proportion of women with an SCI > 16 at 6 months will be assessed. Secondary outcomes will include fatigue, sleep related quality of life, depression, anxiety, as well as hot flush interference in those experiencing vasomotor symptoms.

Conditions
Insomnia, Cancer
Being tested
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I), Sleep Hygiene Education (SHE)
Keywords
Cancer, Insomnia, Sleep, Survivorship, Quality of life, Anxiety, Depression, Fatigue, Hot Flushes
Medical subject headings
Sleep Initiation and Maintenance Disorders, Neoplasms, Anxiety Disorders, Depression, Fatigue, Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)Other

    Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be delivered through an online platform called Sleepio (BigHealth Ltd)

  • Sleep Hygiene Education (SHE)Other

    Sleep Hygiene Education (SHE) will be provided electronically

Study groups in NCT05816460
Study groupRoleWhat they receive
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)ExperimentalDigital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be provided on an online digital platform called Sleepio (BigHealth Ltd). Sleepio delivers fully automated CBT-I through 6 sessions, lasting an average of 20 minutes each, over the course of 6 weeks.
Receives: Other: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Sleep Hygiene Education (SHE)Active comparatorThe Sleep Hygiene Education (SHE) provided is based on recognised sleep hygiene advice and will consist of behavioural recommendations concerning lifestyle and environmental factors associated with sleep and insomnia. SHE will be delivered electronically.
Receives: Other: Sleep Hygiene Education (SHE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean continuous change in the intervention group compared to the control arm as measured by the Sleep Condition Indicator Score

    The primary outcome will be the mean continuous change in Sleep Condition Indicator score in the intervention arm compared to the control arm at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. The magnitude of change in SCI score that represents a reliable improvement on the Sleep Condition Indicator is 7 scale points

    Measured: 24 weeks

  2. Proportion of women with SCI score >16 as measured by the Sleep Condition Indicator (SCI) Score

    The co-primary outcome will be the proportion of women with an SCI score > 16 at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. A score of 16 or less is indicative of insomnia.

    Measured: 24 weeks

Secondary outcomes (5)

  1. Sleep related Quality of life as measured by Glasgow Sleep Impact Index (GSII)

    The Glasgow Sleep Impact Index (GSII) is a self report measure which asks patients to generate and assess three domains of impairment unique to their own experience. The three generated areas of impairment are ranked in order of concern on a scale of 1-3, with 1 being the most concerning impairment. Each impairment is then rated on a visual analogue scale with respect to impact in the last two weeks.

    Measured: 12, 24 and 33 weeks

  2. Fatigue as measured by the Fatigue Symptom inventory (FSI)

    The Fatigue Symptom inventory (FSI) is a method of evaluating the impact of fatigue in people with cancer. The scale is composed of 14 items and is designed to evaluate multiple aspects of fatigue, including its perceived severity, frequency, and interference with daily functioning. Items use an 11-point, likert-type scale that ranges from one fatigue-related extreme to another (lower points on the scale denote less acute problems with fatigue. A score of zero denotes no interference, whilst a score of 10 indicated extreme interference). A global score can be obtained for items 1-13.

    Measured: 12, 24 and 33 weeks

  3. Depression as measured by the Patient Health Questionnaire - 8 (PHQ8)

    The Patient Health Questionnaire - 8 (PHQ8) is an 8 item questionnaire used for the diagnosis of depression. Each of the 8 items are allocated a score of 0-3. Scores can range from 0-24. A score of more than 10 indicates a high likelihood of clinical depression. Scores of more than 20 are indicative of severe disease.

    Measured: 12, 24 and 33 weeks

  4. Anxiety as measured by the Generalised Anxiety Disorder - 7 (GAD7) questionnaire

    The Generalised Anxiety Disorder - 7 (GAD7) is a 7 item questionnaire used to screen for generalised anxiety disorder. Each of the 7 items can be allocated a score of 0-3. Total score can range from 0-21. A score of more than 10 indicated a high likelihood of significant anxiety.

    Measured: 12, 24 and 33 weeks

  5. The impact of Hot Flushes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS)

    The Hot Flushes as measured by the Hot Flash Related Daily Interference Scale is a tool for assessing the impact of hot flushes on quality of life. The scale measures the impact of hot flashes on overall Quality of life, as well as on 9 specific activities (work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life). The scale consists of a series of 0-10-point numeric rating scales. A score of zero reflects no interference and a score of 10 denotes complete interference. Total score can range from 0-100.

    Measured: 12, 24 and 33 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start22 May 2023 (estimated)
  3. Primary completion10 Jun 2024 (estimated)
  4. Study completion10 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-armed, parallel group open label randomised controlled trial. Participants will be randomised 1:1 to receive dCBT-I (intervention arm) or to sleep hygiene education (control arm).
Masking
None (open label)
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816460
Sponsor's protocol ID
WHI22BRE
Other IDs
WHI22BRE
Acronym
SACS
Status last verified
May 2023
First submitted
13 Mar 2023
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PubMed 41170811

  • Treacy T, O'Meara Y, Galligan MC, Henry AL, Lensen SF, Higgins MJ, Hickey M, Brennan DJ. The Sleepio After Cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Contemp Clin Trials. 2024 Jan;136:107337. doi: 10.1016/j.cct.2023.107337. Epub 2023 Sep 21.

    PubMed 37741507

Questions about this trial

What is this clinical trial studying?

A study testing Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) and Sleep Hygiene Education (SHE) in people with Insomnia and Cancer, run by University College Dublin at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Donal Brennan, PhD (+353879577510, donal.brennan@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean continuous change in the intervention group compared to the control arm as measured by the Sleep Condition Indicator Score (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05816460, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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