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Trial Title:
The Sleepio After Cancer Study
NCT ID:
NCT05816460
Condition:
Insomnia
Cancer
Conditions: Official terms:
Sleep Initiation and Maintenance Disorders
Conditions: Keywords:
Cancer
Insomnia
Sleep
Survivorship
Quality of life
Anxiety
Depression
Fatigue
Hot Flushes
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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 purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Description:
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) will be delivered through an
online platform called Sleepio (BigHealth Ltd)
Arm group label:
Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)
Intervention type:
Other
Intervention name:
Sleep Hygiene Education (SHE)
Description:
Sleep Hygiene Education (SHE) will be provided electronically
Arm group label:
Sleep Hygiene Education (SHE)
Summary:
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University College Dublin
Address:
City:
Dublin
Zip:
D04V1W8
Country:
Ireland
Contact:
Last name:
Donal Brennan, PhD
Phone:
+353879577510
Email:
donal.brennan@ucd.ie
Contact backup:
Last name:
Teresa Treacy, MB, BCh, BAO
Phone:
+353861606647
Email:
teresa.treacy@ucdconnect.ie
Investigator:
Last name:
Teresa Treacy, MB, BCh, BAO
Email:
Sub-Investigator
Start date:
May 22, 2023
Completion date:
June 10, 2024
Lead sponsor:
Agency:
University College Dublin
Agency class:
Other
Collaborator:
Agency:
Irish Cancer Society
Agency class:
Other
Collaborator:
Agency:
Big Health Ltd.
Agency class:
Other
Collaborator:
Agency:
Research Electronic Data Capture (REDCap)
Agency class:
Other
Source:
University College Dublin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816460
