Digital Behavioural Treatment for Chronic Pain

Chronic Pain Clinical Trial

— DAHLIA  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05066087
• Other study ID #: Dnr 2021-02437
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 410
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• DAHLIA treatment
6 weeks; CBT/ ACT/ process-based treatment; micro-learning format with 4 digital micro-sessions per week; exposure as the core process; guidance to be OPEN, AWARE, ACTIVE; weekly contact with therapist; booster sessions after 2- and 4 months;

Other:
• Treatment as usual
Usual pain treatment; defined post-hoc based on what patients receive

Locations

Country	Name	City	State
Sweden	Psykisk hälsa	Kalmar
Sweden	Rehab Söder	Kalmar
Sweden	Samrehab	Kalmar
Sweden	Capio St Görans Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Linnaeus University, Örebro University, Sweden, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change over time in being Open/ Acceptance	Chronic Pain Acceptance Questionnaire (CPAQ), 6 items rated on a 7-point scale, with higher scores indicating greater levels of pain acceptance	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other	Change over time in being Aware	5 items rated on a 5-point scale, on,'acting with awareness' from the Five Facets MindfulnessQuestionnaire (FFMQ), with greater scores indicating higher levels of awareness	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other	Change over time in being Engaged/ committed action	i) Valueing questionnaire (10 items); (ii) Committed action questionnaire (8 items); all items rated on a 7-point scale, with higher scores indicating greater levels of engagement/ committed behaviour	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other	Change over time in Psychological flexibility	Swedish translation of the Multidimensional psychological flexibility inventory (MPFI), 24 items rated on a 6-point scale with higher scores indicating grater levels of psychological flexibility	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other	Change over time in Self-efficacy	general self-efficacy scale (S-GSE), 10 items rated on a 4-point scale, with lower scores indicating greater levels of self-efficacy	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other	Change over time in Pain self-efficacy	Pain self-efficacy questionnaires (PSEQ-2), 2 items rated on a 7-point scale with higher scores indicating greater levels of pain self-efficacy	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Other	Change over time in Avoidance	Avoidance subscale of Psychological Inflexibility in Pain Scale (PIPS), 8 items rated on a 7-point scale with higher scores indicating greater levels of pain-related avoidance	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Primary	Change over time in Catastrophizing	Subscale of coping strategies questionnaire (CSQ), 6-items rated on a 7-point scale, with higher scores indicating higher levels of catastrophizing	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Primary	Change over time in (Dis)ability/ pain screening	Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ), 10 items rated on a 10-point scale, higher scores indicating higher levels of functioning	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Primary	Change over time in Work ability	Work ability index (WAI), 10 items rated on different scales (0-10 points, 5-point scale, categorical ratings); no total score but individual information that can be translated into an index or analysed individually	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Primary	Change over time in Functioning	Brief pain inventory (BPI-SF), 9 items, question 3-9 rated on a 10-point scale, higher scores indicating greater levels of pain interference	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Secondary	Change over time in Well-being/ depression	Patient Health Questionnaire (PHQ-9), 10 items rated on a 4-point scale, with higher scores indicating greater levels of depressive symptoms	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Secondary	Change over time in Perceived stress	Perceived stress scale (PSS), 10 items rated on a 5-point scale, with higher scores indicating greater levels of perceived stress	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
Secondary	Change over time in Sleep problems	Insomnia Severity Index (ISI), 4 items rated on a 5-point scale, with higher scores indicating greater levels of sleeping problems	Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

External Links

•   Research group website