SLEEP intervention for BACK Pain (SleepBack study): A randomized co-twin trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000672550
• Date of registration: 29/06/2015
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• 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
• Date of first enrolment: 25/11/2015
• Target sample size: 98
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000672550.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Paulo H Ferreira

• Name: Mr Kevin KN Ho

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Other mental health disorders

Chronic low back pain;Insomnia;
Chronic low back pain
Insomnia

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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.

Primary Outcome(s)

Pain Self-efficacy: Pain self-efficacy questionnaire (PSEQ).[Baseline, immediately post-intervention, and three-month follow up post randomisation

]

Function: Patient-specific functional scale (PSFS).

[Baseline, immediately post-intervention, and three-month follow up post randomisation]

Secondary Outcome(s)

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.[Throughout the recruitment and data collection process]

Average pain intensity over the last week: 0-10 pain scale.
[Baseline, immediately post-intervention, and three-month follow up post randomisation]

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.
[Baseline, immediately post-intervention, and three-month follow up post randomisation]

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. [Immediately post-intervention, and three-month follow up post randomisation]

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.
[At the end of the study]

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. [Throughout the study]

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.[Immediately post-intervention]

Insomnia severity: Sleep condition indicator (SCI).[Baseline, immediately post-intervention, and three-month follow up post randomisation]

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.[After first week of intervention and immediately post-intervention]

Physical activity level: International Physical Activity Questionnaire (IPAQ)[Baseline, immediately post-intervention, and three-month follow up post randomisation]

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.
[Throughout the study]

Disability: Roland Morris disability questionnaire.
[Baseline, immediately post-intervention, and three-month follow up post randomisation

]

Sleep quality: Pittsburgh sleep quality index[Baseline, immediately post-intervention, and three-month follow up post randomisation]

Secondary ID(s)

Nil known

Secondary Sponsor(s)

Twins Research Australia (TRA)

Ethics review

Status: Approved
Approval date:
Contact:

University of Sydney Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 20/11/2018
• Date Completed: 09/12/2018