To evaluate the clinical and cost-effectiveness of iSelf-help compared to in-person PMP and to identify and explore the embedded mechanisms of behaviour change and actions of group intervention via process evaluation.
The iSelf-help non-inferiority randomised controlled trial was a pragmatic, assessor-blinded, two-arm RCT. Adults (age ≥18 years) with persistent non-cancer pain referred to a tertiary pain service deemed eligible for a PMP were recruited and block randomised to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help group participated in two 60-minute video-conferencing sessions weekly for 12 weeks (first session led by a peer-support facilitator with lived experience of pain; second session led by clinicians) with access to resources via smartphone application and a password-protected website. Control participants received 12-week group-based, in-person PMP. A nested mixed methods process evaluation mapped behaviour change techniques (BCT) in iSelf-help using the BCT Taxonomy and explored which BCTs and Mechanisms of Action in Group based Intervention (MAGI) participants most valued.
We recruited 113 participants (56 iSelf-help; 57 in person); mean age of 38.2 (13.7) year with 75% (n=85) female, 8% (n=9 gender diverse), and 16% (n=18) Māori. Based on an intention-to-treat analysis on the primary outcome (Modified Roland Morris Disability Questionnaire) at six months (N=73), iSelf-help was non-inferior to the in-person group with a point estimate of -0.4 (∞, 1.5). Programme delivery cost per patient was lower for iSelf-help participants. Out of 93 potential BCTs, 46 were identified across 13 iSelf-help modules. The behavioural mapping of iSelf-help contents showed alignment with the coding of participant experiences for (#1) Goals and planning, (#4) Shaping knowledge, (#8) Repetition and Substitution, (#9) Comparison of outcomes, and (#13) Identity. iSelf-help was physically more accessible and its web resources highly valued. MAGI synthesis showed that participants appreciated the ability to build support networks and used social comparison to challenge their own expectation and increase commitment.
iSelf-help demonstrated comparable clinical effectiveness. The identification of BCTs and mechanisms of action which were valued, are strong candidates for incorporating into PMPs for people with persistent pain. Future research to reinforce the cultural appropriateness of PMP is required.
iSelf-help provides an economic and safe alternative group-based PMP option with increased geographical reach. Theoretically, it enables choice between individual preference of in-person or online health service delivery, providing a more person-centred approach to pain management. Real-time group interactions of people experiencing persistent pain, and especially with a peer facilitator, are highly valued by those attending PMP and thus should be incorporated into online programmes.
online
behaviour change
