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NCT Number: NCT07205991

ADHERE Trial: Strategies to Improve Mobile App Adherence

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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Key information

Conditions

Low Back Pain Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuroscience Research Australia

Sydney, New South Wales, 2031, Australia

Location status: Recruiting

Location contact

James H McAuley, PhD

CONTACT

[email protected]

+61293991266

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

App notifications

Behavioral

Participants will receive the standard app notifications .

Primary outcomes

  1. Number of sessions completed

    Time frame: Week 8 post-randomisation

    Mean difference of the number of sessions completed over 8 weeks between groups.

Secondary outcomes

  1. Adherence rate (completer vs. non-completer)

    Time frame: Week 8 post-randomisation

    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.

  2. Missing follow-up rate

    Time frame: Week 8 post-randomisation

    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.

  3. Withdrawal rate

    Time frame: Week 8 post-randomisation

    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.

  4. Cost-effectiveness

    Time frame: Week 8 post-randomisation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

James H McAuley, PhD

CONTACT

[email protected]

+61293991266

Rodrigo RN Rizzo, PhD

CONTACT

[email protected]

(02) 9399 1000

Sponsors and collaborators

Lead sponsor

Neuroscience Research Australia

Other

Registry information

Official study title

Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)

Acronym: ADHERE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 3, 2025
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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