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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
Date last updated
29/05/2024

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
The goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement.

Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).
Trial website
https://clinicaltrials.gov/study/NCT05846087
Trial related presentations / publications
Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.
Kelly GA, Blake C, Power CK, O'keeffe D, Fullen BM. The association between chronic low back pain and sleep: a systematic review. Clin J Pain. 2011 Feb;27(2):169-81. doi: 10.1097/AJP.0b013e3181f3bdd5.
Bilterys T, Siffain C, De Maeyer I, Van Looveren E, Mairesse O, Nijs J, Meeus M, Ickmans K, Cagnie B, Goubert D, Danneels L, Moens M, Malfliet A. Associates of Insomnia in People with Chronic Spinal Pain: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 19;10(14):3175. doi: 10.3390/jcm10143175.
Amiri S, Behnezhad S. Sleep disturbances and back pain : Systematic review and meta-analysis. Neuropsychiatr. 2020 Jun;34(2):74-84. doi: 10.1007/s40211-020-00339-9. Epub 2020 Mar 12.
Cheatle MD, Foster S, Pinkett A, Lesneski M, Qu D, Dhingra L. Assessing and Managing Sleep Disturbance in Patients with Chronic Pain. Sleep Med Clin. 2016 Dec;11(4):531-541. doi: 10.1016/j.jsmc.2016.08.004. Epub 2016 Oct 27.
Aji M, Glozier N, Bartlett D, Peters D, Calvo RA, Zheng Y, Grunstein R, Gordon C. A feasibility study of a mobile app to treat insomnia. Transl Behav Med. 2021 Mar 16;11(2):604-612. doi: 10.1093/tbm/ibaa019.
Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.
Howarth A, Quesada J, Silva J, Judycki S, Mills PR. The impact of digital health interventions on health-related outcomes in the workplace: A systematic review. Digit Health. 2018 May 10;4:2055207618770861. doi: 10.1177/2055207618770861. eCollection 2018 Jan-Dec.
Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
Aji M, Gordon C, Stratton E, Calvo RA, Bartlett D, Grunstein R, Glozier N. Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance: Systematic Review. J Med Internet Res. 2021 Feb 17;23(2):e24607. doi: 10.2196/24607.
Mameli S, Pisanu GM, Sardo S, Marchi A, Pili A, Carboni M, Minerba L, Trincas G, Carta MG, Melis MR, Agabio R. Oxytocin nasal spray in fibromyalgic patients. Rheumatol Int. 2014 Aug;34(8):1047-52. doi: 10.1007/s00296-014-2953-y. Epub 2014 Feb 8.
Tang NK, Goodchild CE, Sanborn AN, Howard J, Salkovskis PM. Deciphering the temporal link between pain and sleep in a heterogeneous chronic pain patient sample: a multilevel daily process study. Sleep. 2012 May 1;35(5):675-87A. doi: 10.5665/sleep.1830.
Roth SH, Fleischmann RM, Burch FX, Dietz F, Bockow B, Rapoport RJ, Rutstein J, Lacouture PG. Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: placebo-controlled trial and long-term evaluation. Arch Intern Med. 2000 Mar 27;160(6):853-60. doi: 10.1001/archinte.160.6.853.
Malfliet A, Bilterys T, Van Looveren E, Meeus M, Danneels L, Ickmans K, Cagnie B, Mairesse O, Neu D, Moens M, Goubert D, Kamper SJ, Nijs J. The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial. Braz J Phys Ther. 2019 Jan-Feb;23(1):62-70. doi: 10.1016/j.bjpt.2018.10.007. Epub 2018 Oct 29.
Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497.
Jungquist CR, O'Brien C, Matteson-Rusby S, Smith MT, Pigeon WR, Xia Y, Lu N, Perlis ML. The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain. Sleep Med. 2010 Mar;11(3):302-9. doi: 10.1016/j.sleep.2009.05.018. Epub 2010 Feb 4.
Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Afolalu EF, Moore C, Ramlee F, Goodchild CE, Tang NK. Development of the Pain-Related Beliefs and Attitudes about Sleep (PBAS) Scale for the Assessment and Treatment of Insomnia Comorbid with Chronic Pain. J Clin Sleep Med. 2016 Sep 15;12(9):1269-77. doi: 10.5664/jcsm.6130.
Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb;58(2):163-71. doi: 10.1016/j.jpsychores.2004.09.006.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05846087