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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:
A) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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? |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone calls | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions completed | Mean difference of the number of sessions completed over 8 weeks between groups. | Week 8 post-randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 8 post-randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James H McAuley, PhD | Contact | +61293991266 | j.mcauley@neura.edu.au | |
| Rodrigo RN Rizzo, PhD | Contact | (02) 9399 1000 | r.rizzo@neura.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroscience Research Australia | Recruiting | Sydney | New South Wales | 2031 | Australia |
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| Label | URL |
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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).
Data will be made available after the publication of the study reports. There is no end date for the availability of study data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Transparency statement + Protocol + SAP | Jan 12, 2026 | Jan 12, 2026 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Protocol + SAP 2025 | Sep 25, 2025 | Sep 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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General practitioners and statisticians will be blind to group allocation. Blinding will be maintained for the entire duration of the trial until all data have been collected, and data analysis and interpretation have been completed. The personnel involved in the daily operations of the trial (e.g., research assistants and investigators who will provide possible technical support to participants and trial managers) will be unblinded to group allocation and will not be involved in the analyses.
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| Text messages | Behavioral | 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. |
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| App notifications | Behavioral | Participants will receive the standard app notifications . |
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| 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. |
| 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. | 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. | Week 8 post-randomisation |
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