Digital Behavioural Treatment for Chronic Pain

NCT05066087 | Unknown

• 1 other identifier: Dnr 2021-02437
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Change over time in Well-being/ depression

  Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

• Change over time in Perceived stress

  Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

• Change over time in Sleep problems

  Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

Other Outcomes (7)

• Change over time in being Open/ Acceptance

  Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

• Change over time in being Aware

  Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

• Change over time in being Engaged/ committed action

  Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU

Study Arms (2)

DAHLIA treatment

EXPERIMENTAL

6 weeks of online behavioural treatment; mainly self-guided and weekly contact with their therapist

Behavioral: DAHLIA treatment

Treatment as usual

OTHER

receive usual treatment at their rehabilitation centre; detailed information will be collected to define what treatment as usual means in clinical settings.

Other: Treatment as usual

Interventions

DAHLIA treatment BEHAVIORAL

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;

DAHLIA treatment

Treatment as usual OTHER

Usual pain treatment; defined post-hoc based on what patients receive

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator
• Linnaeus University: collaborator
• Örebro University, Sweden: collaborator

Study Sites (4)

Psykisk hälsa

Kalmar, Sweden

Location

Rehab Söder

Kalmar, Sweden

Location

Samrehab

Kalmar, Sweden

Location

Capio St Görans Hospital

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35428645 DERIVED

Related Links

• Research group website

MeSH Terms

Conditions

Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Laureen Bartels, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the RCT data analysis, the researcher will be blinded (not knowing the participants treatment group).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher; Principle Investigator

Model Details: 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)

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 4, 2021
• Study Start: October 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol will be published in a scientific journal in 2022. Analytic plans, codes, and data sets will be shared with prospective publications in 2023.
• Access Criteria: Data, codes, and plans will be shared through publications. Other researchers may furthermore reach out to get access as a collaboration to additional data sets.

Locations

SE (4)