Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000067774
Ethics application status
Approved
Date submitted
27/11/2021
Date registered
20/01/2022
Date last updated
10/05/2024
Date data sharing statement initially provided
20/01/2022
Date results information initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Cognitive Behaviour Therapy for Insomnia delivered via Videoconferencing on University Students with Poor Sleep
Scientific title
A randomised controlled trial examining whether Cognitive Behaviour Therapy for Insomnia delivered in small groups via videoconferencings is effective at improving sleep quality in university students with poor sleep.
Secondary ID [1] 305825 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 324339 0
Condition category
Condition code
Mental Health 321830 321830 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study will be Cognitive Behavioural Therapy for Insomnia (CBT-I) delivered in four weekly, one hour sessions run live in small groups (with a maximum of five students) via videoconferencing. This mode of delivery was chosen as a result of user consultation focus groups run earlier this year with young adult university students. CBT-I has been shown to be efficacious with older adults, but there are few randomised controlled trials (RCTs) with young adult university students.
The same intervention will be given to both the treatment group and the control group after a delay. Weekly group sessions, held using video conferencing via Zoom, will be psychoeducational and interactive in nature, participants will share their experiences and be able to practice skills they learn. The facilitator, a registered psychologist, will be able to give individualised guidance to the participants on how to apply the content of the sessions to their daily lives. Participants will be asked to complete daily tasks, such as recording their sleep, adjusting their sleep times, and writing about their thoughts and emotions related to sleep. These tasks will take approximately 15 minutes per day, on average. Adherence will be monitored with session attendance recorded in each session.
Session 1 : Sleep patterns, rhythms and sleep hygiene
Sleep needs for young adults, the benefits of good sleep for physical and mental health. Participants will learn the importance of sleep routines and habits.
Session 2: Sleep restriction and sleep attitudes and beliefs
Learning sleep restriction skills to limit time in bed to improve sleep in the long run. Explore unhelpful beliefs and thoughts about sleep, explore alternative ways to view sleep.
Session 3: Managing sleep in times of high stress
Coping with exam and assignment time. The effect of poor sleep on learning and memory. Managing emotions to help with sleep, using worry time and problem solving.
Session 4: Managing screen time social media use and general trouble shooting
Limiting screen time and social media if they have become obstacles to good sleep. Exploring areas of difficulty in applying sleep hygiene, sleep restriction, worry time, managing emotions and challenging unhelpful thoughts about sleep.
Intervention code [1] 322219 0
Treatment: Other
Comparator / control treatment
The control group will be a wait list/treatment as usual control group and will receive the same program as the intervention group after a ten week delay/waiting period. During the ten week waiting period they will be able to continue any treatments they were already receiving when they applied for the study but will be asked not to start new treatments during the waiting period.
Control group
Active

Outcomes
Primary outcome [1] 329594 0
Changes in self reported sleep quality, as measured by the Pittsburgh Sleep Quality Index and Insomnia Severity Index and online sleep diaries
Timepoint [1] 329594 0
Baseline, post treatment (week 5), and at one month follow up (week 10). Primary time point is post treatment
Secondary outcome [1] 403114 0
Mental Wellbeing as measured by the Warwick–Edinburgh Mental Wellbeing Scale
Timepoint [1] 403114 0
Baseline, post treatment (week 5), follow up (week 10)
Secondary outcome [2] 403249 0
Suicidal Ideation as measured by The Suicidal Ideation Attributes Scale
Timepoint [2] 403249 0
Baseline, post treatment (week 5) and follow up (week 10)
Secondary outcome [3] 403250 0
Depression, measured by the Patient Health Questionnaire 9 item scale
Timepoint [3] 403250 0
Baseline, post treatment (week 5) and follow up (week 10)
Secondary outcome [4] 403251 0
Anxiety measured by the Generalised Anxiety Disorder Scale 7 item scale
Timepoint [4] 403251 0
Baseline, post treatment (week 5) and follow up (week 10)
Secondary outcome [5] 403252 0
Alcohol Use, measured by the Alcohol Use Disorders Identification Test.
Timepoint [5] 403252 0
Baseline, post treatment (week 5) and follow up (week 10)
Secondary outcome [6] 403254 0
Smart Phone use measured by the Smart Phone Addiction Scale
Timepoint [6] 403254 0
Baseline, post treatment (week 5) and follow up (week 10)
Secondary outcome [7] 403399 0
Treatment satisfaction survey
Timepoint [7] 403399 0
Post treatment week 5
Secondary outcome [8] 403534 0
Changes in total sleep time as measured by self report sleep diaries.
Timepoint [8] 403534 0
Baseline, post treatment (week 5), and at one month follow up (week 10).
Secondary outcome [9] 404600 0
Changes in sleep onset latency as measured by self report sleep diaries.
Timepoint [9] 404600 0
Baseline, post treatment (week 5), and at one month follow up (week 10).
Secondary outcome [10] 404602 0
Changes in wake time after sleep onset as measured by self report sleep diaries.
Timepoint [10] 404602 0
Baseline, post treatment (week 5), and at one month follow up (week 10).
Secondary outcome [11] 404603 0
Changes in sleep efficiency as measured by self report sleep diaries.
Timepoint [11] 404603 0
Baseline, post treatment (week 5), and at one month follow up (week 10).
Secondary outcome [12] 434922 0
Dysfunctional Beliefs about Sleep. This is measured by the Dysfunctional Beliefs about Sleep Scale (DBAS) a 16 item self report questionnaire, where participants respond on an 11 point Likert scale indicating how strongly they believe the statement (0- strongly disagree to 10 - strongly agree).
Timepoint [12] 434922 0
Secondary outcome [13] 434923 0
Dysfunctional Beliefs about Sleep. This is measured by the Dysfunctional Beliefs about Sleep Scale (DBAS) a 16 item self report questionnaire, where participants respond on an 11 point Likert scale indicating how strongly they believe the statement (0- strongly disagree to 10 - strongly agree).
Timepoint [13] 434923 0
Baseline, post treatment (week 5) and at one month follow up (week 10).
Secondary outcome [14] 434924 0
Pre Sleep Arousal. This was measured by the Pre Sleep Arousal Scale (PSAS) a 16 item self report questionnaire where participants respond a 5 point Likert scale indicating how intensely they experience the symptoms described - (1- not at all through to 5 - extremely).
Timepoint [14] 434924 0
Baseline, post treatment (week 5) and at one month follow up (week 10).
Secondary outcome [15] 434925 0
Pre Sleep Arousal. This was measured by the Pre Sleep Arousal Scale (PSAS) a 16 item self report questionnaire where participants respond a 5 point Likert scale indicating how intensely they experience the symptoms described - (1- not at all through to 5 - extremely).
Timepoint [15] 434925 0
Baseline, post treatment (week 5) and one month follow up (week 10).

Eligibility
Key inclusion criteria
1. Aged from 17 to 25 years
2. Enrolled in a university degree at any Australian university
3. Living in Australia and able to attend sessions in the Australian Eastern Standard Time (AEST) zone or Australian Eastern Daylight Time (AEDT) zone.
4. Experiencing sleep difficulties (scores of 10 or greater on the Insomnia Severity Index)
5. Proficient in English language
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People under 17 or over 25 years of age (this study is focused on emerging adults aged from 18 to 25 years)
2. People with hypersomnolence, narcolepsy, a neurological disorder, schizophrenia or with a history of manic episodes.
3. Current acute suicide risk (scoring more than 21 on the Suicidal Ideation Attributes Scale)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant eligibility for the study will be assessed automatically according to participants' responses to self report questionnaires. The online questionnaire will be automatically scored and will subsequently inform participants if they are eligible to take part. They will then be allocated randomly to either control or intervention group by random number generating software. Hence the allocation will be concealed from the researchers at the time participants enrol in the study. The control group is a waitlist treatment as usual control group, allocation cannot be concealed from the participant once they have been allocated to the group as they will have to complete questionnaires initially and wait ten weeks to take part in the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation (using random.org) will be used to allocate participants to either the control or intervention group . Randomisation occurs after a participant is accepted into the trial and is therefore concealed from the researchers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants will receive the same intervention, however the control group will receive the intervention after a ten week delay. This is so data from the intervention can be compared with the control group throughout the study and at a follow up. After follow up the control group will be given the same treatment program the intervention group originally received.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The plan is to enrol 100 subjects to complete the RCT with half randomly allocated to the intervention group (n=50) and half randomly allocated to the control group (n=50). The nominated sample is based on using an alpha set at 0.05, and power 80%, power calculations indicate that a minimum sample size of 41 per group will have sufficient power to detect a between-groups effect size of 0.63 (a medium effect size). The study is powered to detect these differences at post-treatment on the primary outcome measure. This sample size calculation is based on the between-groups effect size (0.63) which was derived from a meta-analysis of the efficacy of psychological interventions to improve sleep quality in a university student population completed in an earlier phase of this project. To anticipate the dropout, we are going to allocate at least 50 participants for each control and intervention group (N=100).A linear mixed effects regression model will be used to analyse the data over the time points (baseline, post intervention and follow up), with fixed factors of time, group and time by group entered into the model. This analytic approach is the preferred method for analysing repeated measures as it more effectively manages missing data and better accounts for the correlation between the repeated measurements on the same subject inherent in pre post design clinical trials

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2023
Actual
27/01/2023
Date of last participant enrolment
Anticipated
1/07/2023
Actual
31/08/2023
Date of last data collection
Anticipated
13/11/2023
Actual
5/11/2023
Sample size
Target
100
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310174 0
Government body
Name [1] 310174 0
NHMRC Centre for Research Excellence in Suicide Prevention
Country [1] 310174 0
Australia
Funding source category [2] 310233 0
Government body
Name [2] 310233 0
The Prevention Hub, The Australian Government Department of Health
Country [2] 310233 0
Australia
Funding source category [3] 310234 0
Charities/Societies/Foundations
Name [3] 310234 0
Perpetual Impact
Country [3] 310234 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Black Dog Institute
Address
Hospital Road,
Prince of Wales Hospital,
Randwick NSW Australia 2031
Country
Australia
Secondary sponsor category [1] 311259 0
University
Name [1] 311259 0
The University of New South Wales
Address [1] 311259 0
Mathews building
UNSW Sydney
Kensington Campus
NSW, Australia, 2052
Country [1] 311259 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309861 0
Human Research Ethics Committee, The University of New South Wales
Ethics committee address [1] 309861 0
The Human Research Ethics Committee
UNSW
Sydney NSW 2052 Australia
Ethics committee country [1] 309861 0
Australia
Date submitted for ethics approval [1] 309861 0
05/10/2021
Approval date [1] 309861 0
31/01/2022
Ethics approval number [1] 309861 0
HC210959

Summary
Brief summary
This RCT seeks to evaluate the outcomes of CBT-I delivered via videoconferencing with young adult university students. Self reported sleep quality is the primary outcome in this study.. Outcomes will be compared pre to post treatment with a one month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115642 0
A/Prof Jill Newby
Address 115642 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 115642 0
Australia
Phone 115642 0
+61 02 93824372
Fax 115642 0
Email 115642 0
[email protected]
Contact person for public queries
Name 115643 0
Ms Michelle Tadros
Address 115643 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 115643 0
Australia
Phone 115643 0
+61 02 93824630
Fax 115643 0
Email 115643 0
[email protected]
Contact person for scientific queries
Name 115644 0
A/Prof Jill Newby
Address 115644 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 115644 0
Australia
Phone 115644 0
+61 02 93824630
Fax 115644 0
Email 115644 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy concerns


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.