From the identification of biopsychosocial risk factors to an increase in pain-related self-efficacy (IDRIS) - The online-based conveyance of an explanatory model for chronic back pain: Study protocol of a cohort multiple randomized controlled trial.

BACKGROUND

Back pain has a high global prevalence and carries a substantial risk for chronification. Biopsychosocial factors are assumed to be critical in the transition from acute to chronic back pain. Digital interventions are a promising tool to educate patients about their complaints. Thus, providing patients with an explanatory model regarding their individual risk factors in the early stage of their complaints via the internet might thus be a valuable approach in treatment.

OBJECTIVES

The objectives of the present online study are to investigate the influence of a personalized psychoeducational intervention on self-efficacy and functioning and to examine biopsychosocial risk factors for symptom chronification. The intervention is based on a current model summarizing the empirical knowledge on relevant factors for persistent somatic symptoms, which has not been studied in back pain patients yet.

METHODS

An observational cohort of patients with acute and subacute back pain ( = 564) will be asked about biopsychosocial risk factors via online survey at baseline, 4-week, and 12-week follow-up. Within this cohort, a randomly selected group of 132 participants (intervention group) with psychological burden (MCS-12 score of the SF-12 ≤ 50) and relevant somatic symptom intensity and interference (mean sum score of two numeric rating scales ≥5) and no prior psychotherapeutic treatment will be offered a personalized explanatory model in the form of an animated psychoeducational video. The video will be personalized in terms of participants' individual symptom profile and will be made accessible to watch online for 7 days. Participants will be compared to a control group receiving no treatment regarding change in pain-specific self-efficacy after 1 month as primary outcome, and change in functioning after 1 and 3 months, respectively, as secondary outcomes. Acceptance and usefulness of the intervention will be evaluated using the number of video views and a numeric rating scale.

DISCUSSION

This is the first investigation of a personalized, video-animated online psychoeducation based on patients' individual risk factors for the chronification of back pain and the first systematic evaluation of the risk factors included in a comprehensive aetiological model on persistent somatic symptoms in back pain patients. This way, this study contributes to the understanding of cross-disorder psychopathological factors and a stronger consideration of biopsychosocial factors in the treatment of persistent somatic symptoms. If proven effective, the internet-based intervention will make an important contribution to the early treatment of back pain.

ETHICAL APPROVAL

The study was approved by the Local Psychological Ethics Committee (LPEK) at the Center for Psychosocial Medicine of the University Medical Center Hamburg-Eppendorf.

TRIAL REGISTRATION

The study was registered at the German Clinical Trials Register in December 2021 (registration trial number: DRKS00025445).