- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05066087
Digital Behavioural Treatment for Chronic Pain (DAHLIA)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Laureen Bartels, PhD
- Phone Number: 0046739341747
- Email: sara.bartels@ki.se
Study Contact Backup
- Name: Rikard Wicksell, PhD
- Email: rikard.wicksell@ki.se
Study Locations
-
-
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Kalmar, Sweden
- Psykisk hälsa
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Kalmar, Sweden
- Rehab Söder
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Kalmar, Sweden
- Samrehab
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Stockholm, Sweden
- Capio St Görans Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria
Participant must fulfil the following:
- be 18 to 65 years of age
- reporting a pain duration of ≥ 3 months
- being able to communicate in Swedish
- having access to a computer, smartphone, and the internet in their home environment.
Exclusion criteria:
Participant may not
- be injury or illness that require immediate assessment or different treatment, or is expected to progress significantly during the next 6 months
- taking unstable medication (i.e., changes in medication during the past 3 months or expected within the next 3 months)
- having received previous CBT treatment (including ACT) during the past 6 months
- havning severe psychiatric co-morbidity (e.g., high risk of suicide)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DAHLIA treatment
6 weeks of online behavioural treatment; mainly self-guided and weekly contact with their therapist
|
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
receive usual treatment at their rehabilitation centre; detailed information will be collected to define what treatment as usual means in clinical settings.
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Usual pain treatment; defined post-hoc based on what patients receive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change over time in Catastrophizing
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in (Dis)ability/ pain screening
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Work ability
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Functioning
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change over time in Well-being/ depression
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Perceived stress
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Sleep problems
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change over time in being Open/ Acceptance
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
Chronic Pain Acceptance Questionnaire (CPAQ), 6 items rated on a 7-point scale, with higher scores indicating greater levels of pain acceptance
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Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
Change over time in being Aware
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
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Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
Change over time in being Engaged/ committed action
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Psychological flexibility
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Self-efficacy
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Pain self-efficacy
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Change over time in Avoidance
Time Frame: Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Laureen Bartels, PhD, Karolinska Institutet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2021-02437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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