The Sleepio After Cancer Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2024-06-10

Brief Summary

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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.

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Detailed Description

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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

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Insomnia Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)

Digital 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.

Group Type EXPERIMENTAL

Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)

Intervention Type OTHER

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

Sleep Hygiene Education (SHE)

The 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.

Group Type ACTIVE_COMPARATOR

Sleep Hygiene Education (SHE)

Intervention Type OTHER

Sleep Hygiene Education (SHE) will be provided electronically

Interventions

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Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)

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

Intervention Type OTHER

Sleep Hygiene Education (SHE)

Sleep Hygiene Education (SHE) will be provided electronically

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No