Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000672550
Ethics application status
Approved
Date submitted
12/06/2015
Date registered
29/06/2015
Date last updated
28/10/2019
Date data sharing statement initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
SLEEP intervention for BACK Pain (SleepBack study): A randomized co-twin trial
Scientific title
Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Feasibility
Randomized Co-Twin Controlled Trial
Secondary ID [1] 286848 0
Nil known
Universal Trial Number (UTN)
U1111-1170-9167
Trial acronym
SleepBack Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 295240 0
Insomnia 295242 0
Condition category
Condition code
Musculoskeletal 295486 295486 0 0
Other muscular and skeletal disorders
Mental Health 295673 295673 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group will receive a web-based cognitive behavioral therapy (CBT) course comprised of six online sessions, once per week, delivered by an animated personal therapist (avatar), with automated web and email support developed by Sleepio limited (see www.sleepio.com/research). Each session has a minimum duration of 20 minutes. In this web-based program, underlying algorithms feed the delivery of information, support, and advice in a personally tailored manner. The CBT content is consistent with the literature and covers behavioural (eg sleep restriction, stimulus control) and cognitive (eg thought re-structuring, imagery, articulatory suppression, paradoxical intention, mindfulness) strategies. It also includes additional relaxation strategies and advice on lifestyle and bedroom factors (sleep hygiene). Participants will have access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users will also be able to participate in a moderated social network/community of users.

All web-based interactions from the participants in the web-based CBT course will be electronically stored and participation activity will be assessed. We will record the following information: diary entries, session activities, engagement with the community, adherence to tasks.
Intervention code [1] 292014 0
Lifestyle
Intervention code [2] 292015 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will be also given a web-based education program delivered by email. Participants will receive a weekly email, during 6 weeks period (to match the CBT-group), containing material with information regarding sleeping, mainly extracted from the Sleepio library. The participants in this group will receive one email per week. The number of participants that have read each email will be recorded. This intervention was chosen for the control group because there is insufficient evidence that sleep hygiene alone is effective in the treatment of chronic insomnia.
Control group
Active

Outcomes
Primary outcome [1] 295213 0
Function: Patient-specific functional scale (PSFS).
Timepoint [1] 295213 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Primary outcome [2] 295215 0
Pain Self-efficacy: Pain self-efficacy questionnaire (PSEQ).
Timepoint [2] 295215 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [1] 315082 0
Average pain intensity over the last week: 0-10 pain scale.
Timepoint [1] 315082 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [2] 315085 0
Disability: Roland Morris disability questionnaire.
Timepoint [2] 315085 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [3] 315086 0
Physical activity level: International Physical Activity Questionnaire (IPAQ)
Timepoint [3] 315086 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [4] 315087 0
Insomnia severity: Sleep condition indicator (SCI).
Timepoint [4] 315087 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [5] 315088 0
Sleep quality: Pittsburgh sleep quality index
Timepoint [5] 315088 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [6] 315089 0
Sleep efficiency: data obtained from the sleep diary.

Sleep efficiency is the ratio of time spent asleep (total sleep time) to the amount of time spent in bed. Specifically, the following questions will be asked: “What time did you get into bed?”, “What time did you try to go sleep?”, “How long did it take you to fall asleep?”, “How many times did you wake up during the night?”, “In total, how long did these awakenings last?”, “What time was your final awakening?”, “What time did you get out of bed for the day?”.

Participants in the intervention group will be required to answer these questions daily while those on the control group will answer at baseline and follow-ups.
Timepoint [6] 315089 0
Baseline, immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [7] 315466 0
Recruitment rate
Throughout the recruitment process, records will be kept regarding the number of twins screened for entry to the trial. If the twins are not admitted to the trial, the reason why they were ineligible for inclusion will be recorded. Similarly, if eligible, the reasons declining participation in the trial will be noted.
Timepoint [7] 315466 0
Throughout the recruitment and data collection process
Secondary outcome [8] 315467 0
Attendance and adherence to intervention programs
According to the current trial protocol, each participant in the experimental and control group will be required to participate in a web-based for a period of 6 weeks. All web-based interactions from the participants in the web-based CBT course will be electronically stored and participation activity will be assessed. The following data will be used: diary entries, session activities, engagement with the community, adherence to tasks.
Timepoint [8] 315467 0
Throughout the study
Secondary outcome [9] 315468 0
Follow-up rate
The number of participants completing the intervention program and answering the follow-up questionnaires will be recorded. The number of participants lost in each phase of the study will be noted and the reasons for dropping out will be recorded when possible.
Timepoint [9] 315468 0
Immediately post-intervention, and three-month follow up post randomisation
Secondary outcome [10] 315469 0
Contamination of intervention
Despite all the advantages in conducting a randomised co-twin trial, contamination of interventions between twins in a pair could be a threat to the methodological quality of the trial. Upon completion of the study intervention, participants will be required to answer questions regarding this issue.
Timepoint [10] 315469 0
Immediately post-intervention
Secondary outcome [11] 315470 0
Intervention credibility

Participants will be asked to rate the intervention credibility (measured with the Intervention Credibility Scale) after the first week of intervention. At the end of the intervention, participants will be asked “Which intervention did you receive?” to check participant blinding.
Timepoint [11] 315470 0
After first week of intervention and immediately post-intervention
Secondary outcome [12] 315471 0
Twins opinion regarding the intervention

A phone interview will be used to investigate the twins' opinion regarding the intervention and study. The interview will be conducted with twins that have concluded the study and also with those who have dropout. The phone interview will be recorded. They will be required to answer questions regarding:
i) their experience with the intervention,
ii) what they liked and what they did not like about it,
iii) how difficult was to follow the protocol, to answer the questionnaires and to receive a complete web-based intervention,
iv) what should be changed for the intervention to be more pleasant (in their opinion),
v) opinion regarding the efficacy of the intervention for their sleep and/or low back pain problems,
vi) would they recommend this intervention to someone else,
vii) barriers experienced during the trial period.
Timepoint [12] 315471 0
At the end of the study
Secondary outcome [13] 315472 0
Difficulties/barriers to completing the trial

Every issue experienced during the study will be recorded, such as technical problems. This information will help us to anticipate the potential problems when conducting the trial in the future.
Timepoint [13] 315472 0
Throughout the study

Eligibility
Key inclusion criteria
Twin Population:
Complete monozygotic or dizygotic twin pairs, with current email address in the Australian Twin Registry (ATR) database, with concomitant chronic low back pain (longer than 6 weeks) and symptoms of insomnia, and having current access to the internet with a device with speaker, such as computer or tablet.

General Population
People with concomitant chronic low back pain (longer than 6 weeks) and symptoms of insomnia, and having current access to the internet with a device with speaker, such as computer or tablet.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder), spinal surgery in past 12 months, current use of medication or any other treatment for insomnia or for depression, pregnant or lactating women, severe or extremely severe symptoms of depression, being in “poor” or “very poor” physical or mental health (self-report), presence of substance use disorder (self-report), shift worker, exceeding a threshold for other sleep disorder, unknown zygosity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Twins Cohort:
Twins registered with the ATR will be invited to participate in this study based on the answers to a previous health and lifestyle questionnaire that has been designed by the ATR (ATR Health & Lifestyle 2014-002 study). Twins will be invited to answer a screening questionnaire. The ATR will send to the researcher the details of the twins who met the inclusion criteria based on the answers of the screening questionnaire. Once both twins in a pair meet these inclusion criteria and agree to participate in the study, we will randomise them into two groups. Allocation to the two intervention groups will be blinded and performed using a computer-generated random allocation schedule operated by a remote researcher and concealed from the main assessor of the study.

General Cohort:
Individual participants which meet the inclusion criteria and agree to participate in the study, will be randomised into two groups. Allocation to the two intervention groups will be blinded and performed using a computer-generated random allocation schedule operated by a remote researcher and concealed from the main assessor of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be blinded and performed using a computer-generated random allocation schedule operated by a remote researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Twin cohort:
Each twin within a pair will be randomly allocated to one of the intervention groups. Both twins within a pair will start the intervention at a synchronised time.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be stored in spreadsheets and transferred to appropriate statistical software for analysis by an investigator blinded to group allocation. Spreadsheets will be regularly scrutinised for omissions and errors.

Separate analyses will be conducted to determine the effects of intervention at the different follow ups. Analysis will be by intention-to-treat, with data being analysed for all randomized subjects for whom follow-up data will be available. No attempt will be made to impute values for missing data. Cases with missing data at a particular follow-up will be dropped from analyses. The emphasis in the analysis will be on estimation of the effects of intervention rather than hypothesis testing. To maximize precision we will use analysis of covariance. For each analysis the only covariate, chosen a priori, will be the baseline value of the outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2015
Actual
25/11/2015
Date of last participant enrolment
Anticipated
31/01/2018
Actual
29/08/2018
Date of last data collection
Anticipated
28/11/2018
Actual
9/12/2018
Sample size
Target
98
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291406 0
Self funded/Unfunded
Name [1] 291406 0
Country [1] 291406 0
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
Faculty of Health Sciences
Cumberland Campus
75 East Street
LIDCOMBE NSW 2141
Country
Australia
Secondary sponsor category [1] 290084 0
Other Collaborative groups
Name [1] 290084 0
Twins Research Australia (TRA)
Address [1] 290084 0
University of Melbourne
3/207 Bouverie St, Carlton, VIC, 3010
Country [1] 290084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292954 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 292954 0
Ethics committee country [1] 292954 0
Australia
Date submitted for ethics approval [1] 292954 0
24/04/2015
Approval date [1] 292954 0
25/06/2016
Ethics approval number [1] 292954 0
2015/386

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

Contacts
Principal investigator
Name 57782 0
A/Prof Paulo H Ferreira
Address 57782 0
Room 155, O Block, Cumberland Campus C42
The University of Sydney 75 East St Cumberland Campus Faculty of Health Sciences Lidcombe, Sydney, NSW 2141
Country 57782 0
Australia
Phone 57782 0
+61 2 9351 9397
Fax 57782 0
Email 57782 0
[email protected]
Contact person for public queries
Name 57783 0
Kevin KN Ho
Address 57783 0
Musculoskeletal Research Group Lab, Cumberland Campus The University of Sydney 75 East St Cumberland Campus Faculty of Health Sciences Lidcombe, Sydney, NSW 2141
Country 57783 0
Australia
Phone 57783 0
+61 2 9351 9010
Fax 57783 0
Email 57783 0
[email protected]
Contact person for scientific queries
Name 57784 0
Paulo H Ferreira
Address 57784 0
Room 155, O Block, Cumberland Campus C42
The University of Sydney 75 East St Cumberland Campus Faculty of Health Sciences Lidcombe, Sydney, NSW 2141
Country 57784 0
Australia
Phone 57784 0
+61 2 9351 9397
Fax 57784 0
Email 57784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plans to make the raw data public.
Below is from the Participant Information Statement Form which participants consent to.
"By providing your consent, you are agreeing for us to collect personal information about you for the purposes of this research study. Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise. Any recording will be used for analysis only. Study findings may be published, but you will not be individually identifiable in these publications.

The information you provide for this project will be a valuable resource for both current and future research. We will keep the information we collect for this study for use in future ethically approved research. Your data will be stored securely and separately from any personal information that may identify you and your privacy will be protected within the limits of the law."


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
289Study protocolPinheiro M, Ho K, Ferreira M, Refshauge K, Grunstein R, Hopper J, Maher C, Koes B, Ordoñana JR, Ferreira P. Efficacy Of A Sleep Quality Intervention In People With Low Back Pain: Protocol For A Feasibility Randomized Co-Twin Controlled Trial. Twins Research and Human Genetics, 2016: Oct;19(5):492-501   https://www.cambridge.org/core/journals/twin-resea... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a sleep quality intervention in people with low back pain: Protocol for a feasibility randomized co-twin controlled trial.2016https://dx.doi.org/10.1017/thg.2016.67
EmbaseEfficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial.2022https://dx.doi.org/10.1186/s40814-022-01087-z
N.B. These documents automatically identified may not have been verified by the study sponsor.