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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]

None

Universal Trial Number (UTN)

U1111-1214-1030

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Insomnia Disorder

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

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]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Changes in sleep scores as recorded on the sleep condition indicator

Timepoint [1]

Baseline, three weeks (primary time-point) and 12 weeks after intervention commencement

Secondary outcome [1]

Changes in mood scores as recorded on the DASS-Youth questionnaire

Timepoint [1]

Baseline, three weeks and 12 weeks after intervention commencement

Secondary outcome [2]

Changes in perceived conflict scores as recorded on the parent-adolescent conflict scale (Robin & Foster, 1989)

Timepoint [2]

Baseline, three weeks and 12 weeks after intervention commencement

Secondary outcome [3]

Changes in fatigue scores as recorded on the Flinders fatigue scale

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2042 - Newtown

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Camperdown NSW 2006

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Camperdown NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

University of Sydney
Camperdown
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2018

Approval date [1]

11/05/2018

Ethics approval number [1]

2018/091

Summary

Brief summary

The primary purpose of the current study is to evaluate whether a brief behavioural treatment for insomnia (BBT-i) improves sleep for adolescents (aged 12-17 years). We will also monitor mood and behavioural changes using self- and parent-reports. 

Around 10% of 13-18 year old Australians meet DSM-5 criteria for insomnia and up to 70% of teenagers are sleep deprived. The current solution to this highly prevalent condition is often hypnotic pharmacotherapy, despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Behavioural interventions are recommended as the front-line treatment for sleep disordered behaviour for adolescents, yet both prescription and non-prescription medications are widely used, often in the absence of medical advice. BBT-I provides a potentially effective alternative. BBT-I includes psychoeducation around sleep hygiene, stimulus control (i.e., learning healthy associations with sleep cues), and sleep quality (regulating sleep patterns to enhance sleep quality). 

Literature supports the appropriateness of behavioural sleep strategies for adolescents. The methods to be used in this study have been used extensively in past child and adolescent research involving various formats/sequences of delivery, albeit in ways that differ to the brief format that is to be evaluated here. Importantly, the specific components of the current sleep program have been used for children as young as 6 years.

We expect that adolescents will experience improved sleep after the 3-week intervention period. We also anticipate positive changes in mood (e.g., depression, anxiety and stress) and behaviour (e.g., interactions with parents) after the 3-week intervention period. We will evaluate if any changes are maintained 2-months after the 3-week intervention period.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/375102-HREC Ethics Approval May 2018.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof David Hawes

Address

Clinical Psychology Unit
Level 3 M02F - 94 Mallett Street Campus
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9114 4344

Fax

david.hawes@sydney.edu.au

Contact person for public queries

Name

Greg Quartly-Scott

Address

Clinical Psychology Unit
Level 2 M02F - 94 Mallett Street Campus
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9114 4343

Fax

gqua5605@uni.sydney.edu.au

Contact person for scientific queries

Name

Greg Quartly-Scott

Address

Clinical Psychology Unit
Level 2 M02F - 94 Mallett Street Campus
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9114 4343

Fax

gqua5605@uni.sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	A brief behavioral treatment for unresolved insomnia in adolescents: A single-case multiple baseline pilot study, evaluating self-reported outcomes of efficacy, safety, and acceptability.	2020	https://dx.doi.org/10.5664/JCSM.8132

N.B. These documents automatically identified may not have been verified by the study sponsor.

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