Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000070730
Ethics application status
Approved
Date submitted
27/11/2021
Date registered
20/01/2022
Date last updated
11/01/2023
Date data sharing statement initially provided
20/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Cognitive Behaviour Therapy for Insomnia via Videoconferencing on University Students with Poor Sleep: Pilot Study
Scientific title
A pilot study examining whether Cognitive Behaviour Therapy for Insomnia delivered in small groups via video conferencing is effective at improving sleep quality in university students with poor sleep.
Secondary ID [1] 305862 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 324411 0
Condition category
Condition code
Mental Health 321888 321888 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 ten 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 studies with young adult university students.
The four weekly small group sessions, conducted through 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 scheduling
Learning sleep scheduling skills to limit time in bed to improve sleep in the long run.
Session 3: Beliefs about sleep
Exploring how thoughts and beliefs about sleep can contribute to sleep difficulties and discuss unhelpful beliefs as well as alternative ways to think about sleep.
Session 4: Preparing the mind for sleep - Managing emotions and worries before bed and preparing for sleep by developing a wind down routine. The program contents will also be summarised. Exploring areas of difficulty in applying sleep hygiene, sleep restriction, worry time, managing emotions and challenging unhelpful thoughts about sleep.
Intervention code [1] 322258 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329644 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] 329644 0
Baseline, post treatment (week 5). Primary time point is post treatment
Secondary outcome [1] 403271 0
Mental Wellbeing as measured by the Warwick–Edinburgh Mental Wellbeing Scale
Timepoint [1] 403271 0
Baseline, post treatment (week 5).
Secondary outcome [2] 403272 0
Suicidal Ideation as measured by The Suicidal Ideation Attributes Scale
Timepoint [2] 403272 0
Baseline, post treatment (week 5).
Secondary outcome [3] 403273 0
Depression, measured by the Patient Health Questionnaire - 9 item scale
Timepoint [3] 403273 0
Baseline, post treatment (week 5).
Secondary outcome [4] 403274 0
Anxiety measured by the Generalised Anxiety Disorder Scale 7 item scale
Timepoint [4] 403274 0
Baseline, post treatment (week 5).
Secondary outcome [5] 403275 0
Alcohol Use, measured by the Alcohol Use Disorders Identification Test.
Timepoint [5] 403275 0
Baseline, post treatment (week 5).
Secondary outcome [6] 403276 0
Social Media Use measured by the Social Media Use Integration Scale.
Timepoint [6] 403276 0
Baseline, post treatment (week 5).
Secondary outcome [7] 403277 0
Smart Phone use measured by the Smart Phone Addiction Scale
Timepoint [7] 403277 0
Baseline, post treatment (week 5).
Secondary outcome [8] 403386 0
Treatment satisfaction survey
Timepoint [8] 403386 0
Post treatment week 5

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 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for the pilot trial will be 25, A paired samples t tests will be used to compare the pre to post changes on the outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
19/06/2022
Date of last participant enrolment
Anticipated
28/02/2022
Actual
8/09/2022
Date of last data collection
Anticipated
31/03/2022
Actual
10/10/2022
Sample size
Target
25
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310214 0
Government body
Name [1] 310214 0
NHMRC Centre for Research Excellence in Suicide Prevention
Country [1] 310214 0
Australia
Funding source category [2] 310231 0
Government body
Name [2] 310231 0
The Prevention Hub, The Australian Government Department of Health
Country [2] 310231 0
Australia
Funding source category [3] 310232 0
Charities/Societies/Foundations
Name [3] 310232 0
Perpetual Impact
Country [3] 310232 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Black Dog Institute
Address
Hospital Road,
Prince of Wales Hospital,
Randwick NSW Australia 2031
Country
Australia
Secondary sponsor category [1] 311308 0
University
Name [1] 311308 0
University of New South Wales
Address [1] 311308 0
Mathews building
UNSW Sydney
Kensington Campus
NSW, Australia, 2052
Country [1] 311308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309895 0
The University of New South Wales Human Research Ethics Committee A
Ethics committee address [1] 309895 0
Ethics committee country [1] 309895 0
Australia
Date submitted for ethics approval [1] 309895 0
22/11/2021
Approval date [1] 309895 0
31/01/2022
Ethics approval number [1] 309895 0
HC210959

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115758 0
A/Prof Jill Newby
Address 115758 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 115758 0
Australia
Phone 115758 0
+61 02 9382 4372
Fax 115758 0
Email 115758 0
[email protected]
Contact person for public queries
Name 115759 0
Michelle Tadros
Address 115759 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 115759 0
Australia
Phone 115759 0
+61 02 93824630
Fax 115759 0
Email 115759 0
[email protected]
Contact person for scientific queries
Name 115760 0
Jill Newby
Address 115760 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 115760 0
Australia
Phone 115760 0
+61 02 93824630
Fax 115760 0
Email 115760 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.