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Co-creating and evaluating an online self-help treatment (iSelf-help) for people with persistent pain

Clinical and cost-effectiveness of an online delivered group-based pain management programme (iSelf-help) in improving pain-related disability for people with persistent pain - A non-inferiority randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000771156
Acronym
iSELFHELP
Enrollment
45
Registered
2019-05-23
Start date
2019-06-07
Completion date
2021-09-03
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The iSelf-help trial is a pragmatic, multi-centred, assessor-blinded, randomised, two-arm, parallel group, non-inferiority study to compare the effectiveness of group-based, online-delivered pain management programme (iSelf-help) as compared to group-based in-person delivered pain management programme in reducing pain-related disability at 6-months. We hypothesise that group iSelf-help will not be less effective than an in-person group PMP.

Interventions

The 12-week group-based online-intervention (iSelf-help) will be delivered via an online smartphone application and a password-protected website. iSelf-help: The iSelf-help has been co-designed with patients with persistent pain and Maori living with persistent pain and their whanau to ensure cultural appropriateness. The iSelf-help consists of 12 online modules similar to in-person pain management programme (PMP). The 12 modules of iSelf-help are: 0) Welcome to Pain management programme, 1)

The 12-week group-based online-intervention (iSelf-help) will be delivered via an online smartphone application and a password-protected website. iSelf-help: The iSelf-help has been co-designed with patients with persistent pain and Maori living with persistent pain and their whanau to ensure cultural appropriateness. The iSelf-help consists of 12 online modules similar to in-person pain management programme (PMP). The 12 modules of iSelf-help are: 0) Welcome to Pain management programme, 1) Exercise, 2) Sensory nervous system, 3) Stress response, 4) Think, feel, do, 5) Memory of pain, 6) Taking charge, 7) Thinking and doing skills, 8) Medication, 9) Sleep, 10) Making plans with pain, 11) Sharing the journey, 12) Pulling it all together Resources: Each module consists of a short introductory video (30s), educational video by a pain management clinician (5mins), videos of patient stories sharing their experiences of managing pain and associated symptoms relevant to the module, relaxation podcasts and additional resources such as animations, illustrated texts and links of additional resources. Each module of iSelf-help will be made available to the participants at the beginning of each week. Participants are asked to use these resources at their own time. In addition, the iSelf-help arm with 8 to 12 participants/group at baseline will receive two, 60-minute sessions weekly for 12 weeks. One 60-minute session/week will be delivered via an online self-management platform by a dedicated pain management clinician (physiotherapist) of our research team. Each session comprises education (30mins), advice on guided exercises (15mins) and relaxation techniques (15mins). Education sessions are likely to focus on knowledge and Cognitive Behavioural Therapy-based self-management skills (e.g. pain education, activity pacing, relaxation, and distraction techniques) similar to in-person PMP. Participants are asked to attend the first session and any of the 5 sessions from the remaining 11 weeks. Later in the same week, the second 60-minute session is likely to be an interactive online closed-group discussion moderated by a health coach (e.g. a trained volunteer from patient advisory group). The group discussion will focus on self-reflection, goal setting, and the sharing of experiences with peers about what went well, and what did not, over the week and developing peer support network. Participants are asked to attend these discussions at their own discretion. Peer interaction: The community page of iSelf-help will provide opportunities for peer-interaction throughout the 12-week period. Acommunity manager (personnel with a health background) will monitor the page for safety of posts shared by participants. Tracking: There will be opportunites for participants to track their exercise, mood level and thought diaries with reminders and nudges to encourage continued use of iSelf-help through the 12-week period.

Sponsors

Prof Leigh Hale
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

People with persistent, non-cancer pain referred for pain management at a tertiary pain management service from the lower half of the North Island and the upper half of the South Island, New Zealand, Participants with any of the following persistent pain conditions will be included in the study: • Persistent primary pain, • Persistent musculoskeletal pain • Persistent posttraumatic and postsurgical pain • Persistent neuropathic pain, • Persistent headache and orofacial pain • Persistent visceral pain. Inclusion criteria (1) Adults with persistent non-cancer pain (defined above) aged 18 years and older, (2) With daily access to a computer/smartphone at home, workplace or in a public location, (3) Currently not experiencing any significant uncontrolled mental health condition (4) Able to provide written informed consent. We will provide internet subscription for the study period for those without internet access.

Exclusion criteria

(1) Participants with severe depression defined as >20 from the 7 items of Depression subscale of Depression, Anxiety, Stress Scale (DASS-21)53 and based on clinical evaluation by CCDHB pain management service. (2) Primary cancer-related pain (3) Planned surgical intervention for pain (4) Concurrent participation in an additional multi-disciplinary group based pain management programme

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026