Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000510549
Ethics application status
Approved
Date submitted
29/04/2015
Date registered
21/05/2015
Date last updated
20/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of bright light and cognitive-behavioural therapy for the treatment of depression and sleep in Australian Defence Force personnel.
Scientific title
Assessing the efficacy of bright light and cognitive-behavioural therapy for the treatment of depression and sleep in ex-defence force personnel
Secondary ID [1] 286608 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disorder 294918 0
Depression 294919 0
Condition category
Condition code
Mental Health 295168 295168 0 0
Depression
Mental Health 295247 295247 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive one of two treatments:

Bright Light Therapy – Participants will be provided with a light box and asked to obtain >30min of 3000 lux ambient light each morning, between 9am and 11am, for 4 weeks. A daily diary will be used to record daily use/ adherence.

Cognitive-behavioural therapy for Insomnia (CBT-I) – 4 x 1hour sessions of CBT-I over 6 weeks administered by a Psychologist. This tailored therapy aims to promote behaviours and cognitions (widely recognised and evidence-based) that facilitate good sleep.
Intervention code [1] 291736 0
Treatment: Devices
Intervention code [2] 291737 0
Behaviour
Comparator / control treatment
Comparison of the efficacy of both treatment
Control group
Active

Outcomes
Primary outcome [1] 294928 0
Depression - Depression, Anxiety and Stress Scale (DASS)
Timepoint [1] 294928 0
3 months from baseline.
Primary outcome [2] 294929 0
objective sleep quality as measured by actigraphy
Timepoint [2] 294929 0
3 months from baseline
Secondary outcome [1] 314372 0
subjective sleep quality - Pittsburgh Quality of Sleep Inventory
Timepoint [1] 314372 0
3 months from baseline

Eligibility
Key inclusion criteria
Ex-defence force personnel with sleeping problems for at least 4 weeks
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe Post traumatic stress disorder (as determined by questionnaire); severe depression or anxiety (as determined by questionnaire); light sensitivity.

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)
Eligible participants will be randomised to receive either bright light therapy or CBT-i, stratifying for gender (male/ female), Insomnia Severity (ISI: 0-14 / 15-28) and depression (DASS score: 0-20 / 21+). Allocation will be concealed, and conducted using centralised randomisation by computer.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
29/05/2015
Actual
29/05/2015
Date of last participant enrolment
Anticipated
Actual
11/07/2016
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
40
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291178 0
Charities/Societies/Foundations
Name [1] 291178 0
Defence Health Foundation
Country [1] 291178 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray, VIC 3011
Country
Australia
Secondary sponsor category [1] 289858 0
None
Name [1] 289858 0
Address [1] 289858 0
Country [1] 289858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292750 0
Victoria University
Ethics committee address [1] 292750 0
Ethics committee country [1] 292750 0
Australia
Date submitted for ethics approval [1] 292750 0
27/11/2013
Approval date [1] 292750 0
17/01/2014
Ethics approval number [1] 292750 0
HREC 13-302

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

Contacts
Principal investigator
Name 56850 0
Prof Gerard Kennedy
Address 56850 0
Cairnmillar Institute
993 Burke Road
Camberwell VIC 3124
Country 56850 0
Australia
Phone 56850 0
+613 9813 3400
Fax 56850 0
Email 56850 0
[email protected]
Contact person for public queries
Name 56851 0
Cathie Stevens
Address 56851 0
Victoria University
Ballarat Rd Footscray VIC 3011
Country 56851 0
Australia
Phone 56851 0
+613 9919 5646
Fax 56851 0
Email 56851 0
[email protected]
Contact person for scientific queries
Name 56852 0
Melinda Jackson
Address 56852 0
School of Health Sciences
RMIT University
Plenty Road, Bundoora, VIC 3083
Country 56852 0
Australia
Phone 56852 0
+613 99257564
Fax 56852 0
Email 56852 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
No additional documents have been identified.