The Sleepio After Cancer Study (SACS)

University College Dublin

Status: Not yet enrolling

Conditions: Insomnia; Cancer

Treatments: Other: Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I); Other: Sleep Hygiene Education (SHE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05816460

WHI22BRE (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 308 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)

Experimental group

Description:

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.

Treatment:

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

Sleep Hygiene Education (SHE)

Active Comparator group

Description:

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.

Treatment:

Other: Sleep Hygiene Education (SHE)