Low Back PainADHERENCT07205991
ADHERE Trial: Strategies to Improve Mobile App Adherence
A study testing Phone calls, Text messages and App notifications in people with Low Back Pain, run by Neuroscience Research Australia at 1 site in Australia.
Trial summary
This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Phone calls, Text messages and App notifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Oct 2025to 26 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing non-specific chronic low back pain (LBP), defined as pain between the 12th rib and the buttock crease.
- LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
- Currently consulting with a general practitioner for their non-specific chronic LBP across Australia.
- Mean pain intensity score on the Numeric Rating Scale ≥ 3/10 in the past week.
- A score of at least moderate on question 8 of the physical functioning component of the SF-36 questionnaire.
- Access to a mobile device with minimal requirements to download the study app (300MB).
Show all 9Show fewer
- An internet connection to access the mobile app functionalities.
- Able to understand English via reading and audio materials.
- Randomised to experimental group at NOTUS Trial.
Who cannot join
- Known or suspected specific spinal (e.g., radiculopathy, fracture) or specific non-spinal non- (e.g., tumour, infection) pathology.
- Less than six months post-spinal surgery.
- Scheduled for major surgery during the program or the follow-up period.
- Known or suspected serious psychiatric condition not being treated by a health professional that would impact adherence to the trial activities.
- Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Neuroscience Research Australia
Sydney, New South Wales, 2031
James H McAuley, PhD, +61293991266, j.mcauley@neura.edu.au
About this study
Official title: Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)
This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. The main question it aims to answer is:
Do phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain?
Participants will:
- Receive pain education and clinical hypnosis via a mobile app for managing chronic LBP; B) Will be contacted up to twice via phone call or text message, or they will only receive standard notifications from the app.
- Conditions
- Low Back Pain
- Being tested
- Phone calls, Text messages, App notifications
- Keywords
- Back Pain, Digital Health, Hypnosis, Pain Education, Chronic Pain
- Medical subject headings
- Low Back Pain, Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callsBehavioural
Participants will receive standard app notifications and be contacted for adherence via two phone calls, a week apart, if they fail to engage with the intervention for more than three consecutive days. The purpose of these calls will be to assess whether participants are experiencing any difficulties using the app or completing the sessions.
Text messagesBehavioural
Participants will receive the standard app notifications and receive a maximum of 2 text messages (SMS) a week apart, if they fail to engage with the intervention for more than three consecutive days.
App notificationsBehavioural
Participants will receive the standard app notifications .
| Study group | Role | What they receive |
|---|---|---|
| App notifications | Active comparator | Participants will receive the standard app notifications. Reminders are automatically sent at 8pm each day. A user can change the time of their reminder or turn off reminders in the app. The purpose of the app notifications is to increase motivation to complete the app sessions. An example app notification is: Your path to pain management is just a session away. Have you listened today? Receives: Behavioral: App notifications |
| Phone calls | Experimental | Participants will receive standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two phone calls or voice messages, one week apart. The purpose of these calls will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. We expect the calls to last no longer than five minutes. The phone call will include the following communication: Hi [Name], it's [Researcher] from Neuroscience Research Australia calling about the NOTUS back pain trial. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system. Receives: Behavioral: Phone calls |
| Text messages | Experimental | Participants will receive the standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two SMS reminders, one week apart. The purpose of these SMS will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. The text messages will include the following: Hey [Name], this is [Researcher] from Neuroscience Research Australia. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system. Receives: Behavioral: Text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions completed
Mean difference of the number of sessions completed over 8 weeks between groups.
Measured: Week 8 post-randomisation
Secondary outcomes (4)
Adherence rate (completer vs. non-completer)
Participants will be classified as "completers" if they have attended at least 24 sessions (new or repeated) during the 8-week treatment period of the host trial. This threshold represents an average of three clinical sessions per week over 8 weeks.
Measured: Week 8 post-randomisation
Missing follow-up rate
Participants will be classified as "follow-up completer" when they completed all primary, secondary and intermediate measures or as "follow-up missing" when they did not complete all primary, secondary and intermediate measures at the 8-week follow-up.
Measured: Week 8 post-randomisation
Withdrawal rate
Participants will be classified as "withdrawal" if they formally withdrew consent, or as "non-withdrawal" if they remained enrolled in the trial at the 8-week follow-up.
Measured: Week 8 post-randomisation
Cost-effectiveness
The mean difference in costs and adherence between groups will be used to calculate the incremental cost-effectiveness ratio (ICER), representing the average additional cost (expressed in Australian dollars - AUD) required to achieve one additional completed session. This outcome reflects the economic efficiency of each engagement strategy (SMS or phone call) compared to others.
Measured: Week 8 post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start30 Oct 2025
- Primary completion26 May 2027 (estimated)
- Study completion26 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will randomly allocate participants from the intervention group of the NOTUS Trial into one of three parallel arms in a 1:1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroscience Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McAuley, Neuroscience Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205991
- Sponsor's protocol ID
- iRECS4383 - SWAT
- Acronym
- ADHERE
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee. Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)
- ClinicalTrials.gov ID
- NCT07205991
- Acronym / sponsor ID
- ADHERE / iRECS4383 - SWAT
- Conditions
- Low Back Pain
- Keywords
- Back Pain, Digital Health, Hypnosis, Pain Education, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Neuroscience Research AustraliaUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 26 May 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. The main question it aims to answer is:
Do phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain?
Participants will:
- Receive pain education and clinical hypnosis via a mobile app for managing chronic LBP; B) Will be contacted up to twice via phone call or text message, or they will only receive standard notifications from the app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will randomly allocate participants from the intervention group of the NOTUS Trial into one of three parallel arms in a 1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| App notifications | Active comparator | Behavioral: App notificationsParticipants will receive the standard app notifications. Reminders are automatically sent at 8pm each day. A user can change the time of their reminder or turn off reminders in the app. The purpose of the app notifications is to increase motivation to complete the app sessions. An example app notification is: Your path to pain management is just a session away. Have you listened today? |
| Phone calls | Experimental | Behavioral: Phone callsParticipants will receive standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two phone calls or voice messages, one week apart. The purpose of these calls will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. We expect the calls to last no longer than five minutes. The phone call will include the following communication: Hi [Name], it's [Researcher] from Neuroscience Research Australia calling about the NOTUS back pain trial. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system. |
| Text messages | Experimental | Behavioral: Text messagesParticipants will receive the standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two SMS reminders, one week apart. The purpose of these SMS will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. The text messages will include the following: Hey [Name], this is [Researcher] from Neuroscience Research Australia. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Experiencing non-specific chronic low back pain (LBP), defined as pain between the 12th rib and the buttock crease.
- LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
- Currently consulting with a general practitioner for their non-specific chronic LBP across Australia.
- Mean pain intensity score on the Numeric Rating Scale ≥ 3/10 in the past week.
- A score of at least moderate on question 8 of the physical functioning component of the SF-36 questionnaire.
Key exclusion criteria (5 listed)
- Known or suspected specific spinal (e.g., radiculopathy, fracture) or specific non-spinal non- (e.g., tumour, infection) pathology.
- Less than six months post-spinal surgery.
- Scheduled for major surgery during the program or the follow-up period.
- Known or suspected serious psychiatric condition not being treated by a health professional that would impact adherence to the trial activities.
- Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callsParticipants will receive standard app notifications and be contacted for adherence via two phone calls, a week apart, if they fail to engage with the intervention for more than three consecutive days. The purpose of these calls will be to assess whether participants are experiencing any difficulties using the app or completing the sessions. | Behavioural | Phone calls |
| Text messagesParticipants will receive the standard app notifications and receive a maximum of 2 text messages (SMS) a week apart, if they fail to engage with the intervention for more than three consecutive days. | Behavioural | Text messages |
| App notificationsParticipants will receive the standard app notifications . | Behavioural | App notifications |
Primary outcome
Number of sessions completed
Time frame: Week 8 post-randomisation
Mean difference of the number of sessions completed over 8 weeks between groups.
4 secondary outcomes
Adherence rate (completer vs. non-completer)
Time frame: Week 8 post-randomisation
Missing follow-up rate
Time frame: Week 8 post-randomisation
Withdrawal rate
Time frame: Week 8 post-randomisation
Cost-effectiveness
Time frame: Week 8 post-randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee. Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).
Related trials for Low Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
Low Back Pain, Functional Motor Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone calls, Text messages and App notifications in people with Low Back Pain, run by Neuroscience Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James H McAuley, PhD (+61293991266, j.mcauley@neura.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions completed (time frame: Week 8 post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.