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 range18 Years – 80 Years

SexALL

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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.

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

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