A sample of 12 adults with chronic primary pain will participate in a personalized cognitive-behavioral therapy protocol.
Cognitive-behavioral therapy (CBT) for chronic primary pain shows small to moderate effect sizes.
Personalization and data-driven clinical decision-making may improve treatment outcomes for individuals with chronic primary pain.
Person-specific treatment targets will be identified using data.
Participants will receive one of ten CBT interventions selected by an algorithm based on their specific needs.
Individual treatment effects will be assessed using Tau-U and Hedges' g, along with conventional pain disability measures.
Simplified
INTRODUCTION: Cognitive-behavioural therapy (CBT) is an effective treatment for chronic primary pain (CPP), but effect sizes are small to moderate. Process orientation, personalisation, and data-driven clinical decision-making might address the heterogeneity among persons with CPP and are thus promising pathways to enhance the effectiveness of CBT for CPP. This study protocol describes one approach to personalise CBT for CPP using network analysis.
METHODS AND ANALYSIS: A with multiple baselines will be combined with (EMA). Feasibility and acceptance of the study procedure will be demonstrated on a sample of n=12 adults with CPP in an outpatient clinic. In phase A, participants complete 21 days of EMA, followed by the standard diagnostic phase of routine clinical care (phase B). Person-specific, process-based networks are estimated based on EMA data. Treatment targets are selected using mean ratings, strength and out-strength centrality. After a second, randomised baseline (phase A'), participants will receive 1 out of 10 CBT interventions, selected by an algorithm matching targets to interventions, in up to 10 sessions (phase C). Finally, another EMA phase of 21 days will be completed to estimate a post-therapy network. Tau-U and Hedges' g are used to indicate individual treatment effects. Additionally, conventional pain disability measures (Pain Disability Index and the adapted Quebec Back Pain Disability Scale) are assessed prior, post, and 3 months after phase C.
ETHICS AND DISSEMINATION: Ethical considerations were made with regard to the assessment-induced burden on the participants. This proof-of-concept study may guide future studies aiming at personalisation of CBT for CPP as it outlines methodological decisions that need to be considered step by step. The project was approved by the local ethics committee of the psychology department of University Kaiserslautern-Landau (#LEK-457). Participants gave their written informed consent prior to any data assessment and app installation. The results of the project will be published, presented at congresses, and relevant data will be made openly accessible via the Open Science Framework (OSF).
TRIAL REGISTRATION NUMBER: NCT06179784.
Key numbers
12
Sample Size
Participants will be recruited to assess the study's effectiveness.
10
Maximum Sessions
The intervention phase allows for tailored therapy sessions.
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Competing interests: All authors of this publication declared their competing interests in detail to the journal. VEH, FK and SS receive payment for the study therapies from WiPP e. V. (university outpatient clinic) as well as free supervision. Therapy sessions and supervision are credited for the psychotherapy training of VEH and FK. WiPP e. V. also provided study materials and infrastructure. All authors are employed at University Kaiserslautern-Landau (RPTU) and receive financial support for professional travels and meetings.
