The Sleepio After Cancer Study

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.

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.

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