CompletedNot Applicable

Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility

United Kingdom60 participantsStarted 2019-09-05

Plain-language summary

The principal objective of the study is to assess the feasibility and preliminary efficacy of an online-delivered CBT-I intervention for those with insomnia or reporting sleep difficulties. The program will be offered to service users of IAPT to establish criteria for the planning of a future large scale RCT study.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 18 years old * Reporting difficulty getting to sleep and/or staying asleep as their primary presentation * Suitability for an internet intervention (i.e. willingness to engage on the iCBT intervention, ability to read English, access internet, the capacity and willingness to consent) * No suicidal or self-harm risk and no specific communication needs. Exclusion Criteria: * Score above 0 on PHQ-9 question 9 * Diagnosed psychotic illness * Currently on psychological or pharmacological treatment for sleep disorder * Alcohol or drug misuse * Previous diagnosis of an organic mental health disorder, * Have an unstable medication regimen.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in insomnia severity (as measured by the Insomnia Severity Index, ISI)

Timeframe: Baseline - Immediately after the intervention

Changes in average sleep efficiency (i.e. total time spent asleep divided by the total time spent in bed in a given day)

Timeframe: Baseline - Immediately after the intervention

Trial details

NCT IDNCT04493593

SponsorSilver Cloud Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-21

View on ClinicalTrials.gov More Insomnia trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in insomnia severity (as measured by the Insomnia Severity Index, ISI)

Timeframe: Baseline - Immediately after the intervention

Changes in average sleep efficiency (i.e. total time spent asleep divided by the total time spent in bed in a given day)

Timeframe: Baseline - Immediately after the intervention