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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05846087




Registration number
NCT05846087
Ethics application status
Date submitted
26/04/2023
Date registered
6/05/2023

Titles & IDs
Public title
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
Scientific title
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study
Secondary ID [1] 0 0
X23-0145
Universal Trial Number (UTN)
Trial acronym
SleepBack
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low-back Pain 0 0
Insomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - sleep retraining therapy
Other interventions - sleep health education modules

Experimental: Treatment - Three weeks of sleep retraining therapy - behavioral component of cognitive behavioral therapy for insomnia. This will be self-delivered by participants digitally using the smart phone App 'SleepFix'.

Active comparator: Control - Sleep health education modules delivered each week for three weeks. Modules contain information about sleep and insomnia; how insomnia affects other aspects of life; what activities influence health sleep (sleep hygiene) and information designed to dispel false beliefs about sleep


BEHAVIORAL: sleep retraining therapy
Sleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed.

Other interventions: sleep health education modules
educational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain interference
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Insomnia severity index (ISI)
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Pain-related beliefs and attitudes about sleep (PBAS)
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
Patient Health Questionnaire-2 (PHQ-2)
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
General Anxiety Disorder-7 (GAD-7)
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
EuroQol five-dimensional (EQ-5D)
Timepoint [7] 0 0
6 weeks

Eligibility
Key inclusion criteria
1. Adults aged = 18 years.
2. Chronic low back pain (pain in lower back region which has been present for 3 months or more).
3. Able to give informed online consent.
4. Insomnia Severity Index Score >10.
5. English fluency.
6. Access to a smartphone and willingness/proficiency to use a mobile app for healthcare.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column.
2. Shift-workers. Regular work that falls outside the hours between 7am and 6pm.
3. Trans-meridian travel to a destination with >2 hours' time-difference (within last 7-days and will subjective reports that they are not experiencing jet lag).
4. Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia).
5. Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism).
6. Sleep devices (e.g. CPAP)
7. Currently receiving psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
8. Professional driver or operate heavy machinery;

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
178
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2037 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cooperative Research Centre for Alertness, Safety and Productivity
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Christopher J Gordon, A/Prof
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James M Puterflam, PhD Candidate
Address 0 0
Country 0 0
Phone 0 0
0414818290
Fax 0 0
Email 0 0
james.puterflam@sydney.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial investigators will be given access to the cleaned data set. The project data set will be housed online in the study web portal created for the study, and all data will be password protected. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information.

Data will not be shared without permission of Principal Investigators. All data available for sharing will be stored on a web-based database located in Australia. After the study, a non-identified dataset may be made available online in a data repository.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05846087