Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000835246
Ethics application status
Approved
Date submitted
15/05/2018
Date registered
17/05/2018
Date last updated
17/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a One Month Brief Behavioural Treatment Improve Sleep for High School Adolescents (ages 12-17): An Open Label Pilot Study
Scientific title
Does a One Month Brief Behavioural Treatment Improve Sleep for High School Adolescents (ages 12-17): An Open Label Pilot Study
Secondary ID [1] 294898 0
None
Universal Trial Number (UTN)
U1111-1214-1030
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 307843 0
Condition category
Condition code
Mental Health 306885 306885 0 0
Other mental health disorders
Mental Health 306902 306902 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Brief Behavioral Treatment for insomnia (BBT-i) is designed as a non-randomised, single arm, open label trial.

Informational materials include an adaptation of the Brief Behavioral Treatment for Insomnia workbook (Pittsburgh, 2007).

Information is provided on sleep hygiene, stimulus control and sleep regulation (the three components of the BBT-I, see Troxel et al., 2012). Sleep regulation involves setting sleep and wake times to enhance sleep efficiency (time spent asleep relative to time spent in bed).

Sleep regulation is implemented and reinforced during a 3 week in-home trial for participants with clinical and/or sub-clinical patterns of insomnia.

The intervention is delivered by a Master’s level student during a face-face consultation.

The procedure involves:

1. Initial telephone screening interview to assess eligibility and provide instructions on completing the daily sleep diary (Time 0)

2. An initial face-face consultation to complete consent and deliver the 45-60 minute intervention (Time 1)

3. 2 x 10 minute telephone calls to assess risk and adherence, weekly (i.e., Time 2 & Time 3) for two weeks after Time 1

4. A second face-face consultation to debrief and provide recommendations for better sleep outcomes base on individual findings (participant specific based on self-report adherence and sleep diary records of sleep patterns) (Time 4)

5. Participants will be followed up at 2 months after Trial completion (Time 5) to assess sleep, mood, and behaviour via mail or face-face consultation as indicated by participants at the Time 4 consultation.

Personalised sleep titration occurs by adjusting time in bed to achieve sleep efficiency rates of ~85% (time asleep relative to time in bed). Time in bed is managed by adjusting ‘time to bed’ – less time in bed if sleep efficiency is low (i.e., later ‘time to bed’).

Adherence is assessed during weekly follow-up. Difficulties adhering to prescribed bed and rise times will be noted and discussed.
Intervention code [1] 301200 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305881 0
Changes in sleep scores as recorded on the sleep condition indicator
Timepoint [1] 305881 0
Baseline, three weeks (primary time-point) and 12 weeks after intervention commencement
Secondary outcome [1] 346875 0
Changes in mood scores as recorded on the DASS-Youth questionnaire
Timepoint [1] 346875 0
Baseline, three weeks and 12 weeks after intervention commencement
Secondary outcome [2] 346876 0
Changes in perceived conflict scores as recorded on the parent-adolescent conflict scale (Robin & Foster, 1989)
Timepoint [2] 346876 0
Baseline, three weeks and 12 weeks after intervention commencement
Secondary outcome [3] 346887 0
Changes in fatigue scores as recorded on the Flinders fatigue scale
Timepoint [3] 346887 0
Baseline, three weeks and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
1. Males & Females aged 12-17 years (years 7-10 High School).
2. Able to give informed written consent.
3. Parental/caregiver consent.
4. Literacy in English.
5. Symptoms of Insomnia Disorder (APA, 2013) as identified by parent/caregiver during telephone screening. Symptoms include difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty.
6. The Sleep Condition Indicator scale scores below 20.
7. Never previously treated with CBT-I.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Existing diagnosis of a psychiatric disorder as identified by parent/caregiver.
2. Sleep disorders (other than untreated insomnia).
3. Severe cognitive impairment that does not allow participants to consent or follow treatment instructions.
4. Recent time-zone travel (within last 1 month).

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
This sample size (n = 19) has been chosen based on previously published pilot studies for the treatment of insomnia for adolescents

Treatment end data will be compared against baseline data for all analyses using linear models. The primary and secondary outcomes can be evaluated using a T-Test of the change scores of continuous data collected at baseline and post treatment only. Additional change scores for follow-up data can be examined using repeated measures ANOVA. Correlational data will be explored. For all tests, we will use 2-tailed p-values with alpha = 0.05 level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/06/2018
Actual
Date of last participant enrolment
Anticipated
21/12/2018
Actual
Date of last data collection
Anticipated
22/03/2019
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22654 0
2050 - Camperdown
Recruitment postcode(s) [2] 22655 0
2042 - Newtown

Funding & Sponsors
Funding source category [1] 299472 0
University
Name [1] 299472 0
The University of Sydney
Country [1] 299472 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 298773 0
None
Name [1] 298773 0
Address [1] 298773 0
Country [1] 298773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300378 0
Human Research Ethics Committee
Ethics committee address [1] 300378 0
Ethics committee country [1] 300378 0
Australia
Date submitted for ethics approval [1] 300378 0
22/01/2018
Approval date [1] 300378 0
11/05/2018
Ethics approval number [1] 300378 0
2018/091

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2690 2690 0 0
/AnzctrAttachments/375102-HREC Ethics Approval May 2018.pdf (Ethics approval)

Contacts
Principal investigator
Name 83466 0
A/Prof David Hawes
Address 83466 0
Clinical Psychology Unit
Level 3 M02F - 94 Mallett Street Campus
The University of Sydney
NSW 2006
Country 83466 0
Australia
Phone 83466 0
+61 2 9114 4344
Fax 83466 0
Email 83466 0
[email protected]
Contact person for public queries
Name 83467 0
Greg Quartly-Scott
Address 83467 0
Clinical Psychology Unit
Level 2 M02F - 94 Mallett Street Campus
The University of Sydney
NSW 2006
Country 83467 0
Australia
Phone 83467 0
+61 2 9114 4343
Fax 83467 0
Email 83467 0
[email protected]
Contact person for scientific queries
Name 83468 0
Greg Quartly-Scott
Address 83468 0
Clinical Psychology Unit
Level 2 M02F - 94 Mallett Street Campus
The University of Sydney
NSW 2006
Country 83468 0
Australia
Phone 83468 0
+61 2 9114 4343
Fax 83468 0
Email 83468 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA brief behavioral treatment for unresolved insomnia in adolescents: A single-case multiple baseline pilot study, evaluating self-reported outcomes of efficacy, safety, and acceptability.2020https://dx.doi.org/10.5664/JCSM.8132
N.B. These documents automatically identified may not have been verified by the study sponsor.