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Digital Behavioural Treatment for Chronic Pain

NCT05066087 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Linnaeus University

    collaborator OTHER

  • Örebro University, Sweden

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Sara Laureen Bartels, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Sweden

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066087 on ClinicalTrials.gov