Clinical trial NCT05066087: Digital Behavioural Treatment for Chronic Pain
Official title: Digital Behavioural Treatment for Improved Functioning and Quality of Life in People With Chronic Pain/ Digital Kognitiv Beteendeterapi för ökad Funktion Och Livskvalitet Hos Personer Med långvarig smärta
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Linnaeus University
name: Örebro University, Sweden
First posted: 2021-10-04
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Focus groups (n=16 patients and n=8 health care professionals); single-arm, iterative sprints with n=10 patients per sprint (total of n=40-60 patients); two-armed RCT with n=180 patients per arm; interviews with stakeholders (minimum of n=6 interviews)
Primary purpose: TREATMENT

Brief summary: Overall project aim: to develop, evaluate, and implement a digital behavioural health treatment to improve well-being in individuals with chronic pain.

The treatment will be integrated into the nationally available 1177 web-platform, which will facilitate long-term use in clinical practice across Sweden. Within the project, the investigators will develop the digital treatment and match it to patients' needs using focus groups; pilot the treatment to evaluate its feasibility and acceptability, preliminary efficacy, and individual change processes using the single case experimental design (SCED) method; conduct a two-armed randomized controlled trial enhanced with SCED to assess the clinical effectiveness, cost-effectiveness, and maintenance of change of the treatment compared to treatment as usual; and monitor the implementation process of the treatment through a business model and stakeholder interviews.

Detailed description: Study 1: Identifying and meeting patients' needs Design: Focus groups with individuals with chronic pain and health care professionals. Aim: To identify participant's needs and utilise user input to match the treatment content and design (prototype 1.0) to needs. Sample: People with chronic pain (two focus groups, n=6-8 per group), health care professionals (HCPs) (e.g., psychologists, psychotherapists trained in cognitive behavioural therapy (CBT)) (one focus group, n=6-8) will be recruited from primary care facilities in the region of Kalmar. Data collection: Focus groups will follow a semi-structured guide and be audio- and video-taped. Field notes will furthermore provide insights into relevant cues and observations given by participants. Outcome: Intervention prototype 2.0 Time plan: Autumn/winter 2021.

Study 3: Feasibility, acceptability, preliminary efficacy, and individual change processes Design: Piloting and optimising the treatment in an iterative process with 4-6 smaller cohorts; user input from each optimisation 'sprint' will be integrated and tested in the subsequent cohort/ sprint; single-case experimental design (SCED) method with randomised baseline length, pre- post- and FU-assessment and post-treatment user interviews. Aim: To evaluate the feasibility and acceptability, the preliminary efficacy, and individual change processes of the digital behavioural health treatment within the 1177 web-platform. Sample: People with chronic pain (n=10 per sprint; total of n=60) will be recruited from primary care facilities in the region of Kalmar; the feasibility and acceptability will also be evaluated in treating HCPs (note: one HCP might treat multiple patients at the same time, and also take place in several sprints), who are therefore also considered participants. Data collection: feasibility/ acceptability: semi-structured debriefing interviews of subjective experience combined with objective measures such as drop-out rate, adherence, system-generated technical use e.g. number of log-in time points, number of modules completed; preliminary efficacy: Pre-, post- 3- and 6-month FU-assessment of self-reports on patients' well-being, data of n=60 patients accumulated across all sprints as the treatment remains functionally constant across all optimisation studies; individual change processes: Lunch and evening reports of well-being at least four times per week over the course of the 6-week treatment using a digital diary, also comparing to the baseline and post-treatment diary assessments. Time plan: 2022.

Study 4: RCT enhanced with SCED evaluating the (cost-) effectiveness and maintenance of change Design: Two-armed RCT enhanced with randomized baseline length SCED method comparing the digital behavioural health treatment to primary care treatment as usual (TAU). Aims: To evaluate the clinical effectiveness of the treatment on behavioural health outcomes, and the cost-effectiveness of the treatment in comparison to TAU. Sample: Patients (n=360, n=180 per group) will be recruited from pain clinics and primary care facilities in the region of Kalmar and potentially other regions (e.g., Östergötland, Jönköping, Stockholm, Uppsala, Örebro). Data collection: Self-report questionnaires will be completed over pre-, post- FU-assessments. Furthermore, the digital diary information on daily well-being will be collected at all assessment time points and over the course of the intervention, in both treatment arms. To determine the cost-effectiveness, information from registers on sick leave, medication, and health care consumption will be used . Time plan: 2023-2024.

Study 2 (pre-Implementation) and study 5 (post-implementation): business model, determinants, and lessons-learned Design: Qualitative study using interviews with stakeholders; deductive analysis of qualitative data mapped on the consolidated framework for implementation research. Aim: Identify barriers and facilitators for the prospective implementation of the treatment and prepare the implementation process using a business model canvas (at baseline, study 2); review the actual use and implementation process at follow-up to present lessons learned (at follow-up, study 5). Sample: Various stakeholders identified via snowball-sampling (e.g., development team and facilitators of 1177 web platform at region Kalmar, health care professionals, health care managers, municipality representatives). Interviews will be conducted until data satisfaction is achieved. Data collection: An initial version of a business model canvas will be discussed with the development team and health care managers. Furthermore, potential barriers and facilitators of prospective use will be identified at baseline via a semi-structured interview with the stakeholders. The practical use and implementation status after the treatment is released to the market (here also referred to as follow-up (FU)) will be described using semi-structured interviews to understand the process retrospectively and present lessons learned. Time plan: baseline autumn 2021, FU in autumn 2024 (after RCT, treatment release to other regions).

Eligibility criteria: Inclusion criteria

Participant must fulfil the following:

1. be 18 to 65 years of age
2. reporting a pain duration of ≥ 3 months
3. being able to communicate in Swedish
4. having access to a computer, smartphone, and the internet in their home environment.

Exclusion criteria:

Participant may not

1. be injury or illness that require immediate assessment or different treatment, or is expected to progress significantly during the next 6 months
2. taking unstable medication (i.e., changes in medication during the past 3 months or expected within the next 3 months)
3. having received previous CBT treatment (including ACT) during the past 6 months
4. havning severe psychiatric co-morbidity (e.g., high risk of suicide)

Primary outcomes:
measure: Change over time in Catastrophizing
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in (Dis)ability/ pain screening
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Work ability
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Functioning
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Secondary outcomes:
measure: Change over time in Well-being/ depression
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Perceived stress
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Sleep problems
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other outcomes:
measure: Change over time in being Open/ Acceptance
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in being Aware
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in being Engaged/ committed action
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Psychological flexibility
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Self-efficacy
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Pain self-efficacy
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
measure: Change over time in Avoidance
timeFrame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Locations:
city: Kalmar
country: Sweden
facility: Psykisk hälsa
city: Kalmar
country: Sweden
facility: Rehab Söder
city: Kalmar
country: Sweden
facility: Samrehab
city: Stockholm
country: Sweden
facility: Capio St Görans Hospital
Study officials:
affiliation: Karolinska Institutet
name: Sara Laureen Bartels, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartels SL, Johnsson SI, Boersma K, Flink I, McCracken LM, Petersson S, Christie HL, Feldman I, Simons LE, Onghena P, Vlaeyen JWS, Wicksell RK. Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project. BMJ Open. 2022 Apr 15;12(4):e059152. doi: 10.1136/bmjopen-2021-059152.