Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial

Abstract

IntroductionChronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).Methods and analysisA two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.Ethics and disseminationThis study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17—FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.Trial registration numberGerman Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.

Are guided internet-based interventions for the indicated prevention of depression in green professions effective in the long run? Longitudinal analysis of the 6- and 12-month follow-up of a pragmatic randomized controlled trial (PROD-A)

“…The effect of reduction of pain-associated disability in the exploratory ITT-analysis can be seen as surprising as GET.ON Chronic pain was not assigned once until 12-month FU. This effect might be due to the fact that some of the study participants screened positive for chronic pain symptomology prior to study inclusion chose to participate in the present trial instead of an alternative study focusing on chronic pain symptomology ( Terhorst et al, 2020 ). Hence, the reduction of pain-associated impairment might be an unspecific, generic intervention effect.…”

“…Policyholders were included if a) they were entrepreneurially active or a contributing spouse, family member or pensioner, b) had at least a subthreshold depressive symptomology (Perceived Health Questionnaire-9 (PHQ-9) ≥ 5) and c) age ≥ 18. Participants were excluded in case of a) current psychotherapeutic treatment, b) indication for suicidal risk and inability to distance from suicidal ideation, and c) preference for participation in the parallel trial PACT-A ( Terhorst et al, 2020 ) if a parallel chronic pain symptomology was present.…”

“…Additionally, the training GET.ON Chronic Pain focusing on psychological distress due to chronic pain symptomology could be assigned. This training was separately evaluated in a parallel randomized controlled trial PACT-A and is described in detail in the corresponding study protocol ( Terhorst et al, 2020 ). If another training was assigned, the consolidating phase followed after completion of the second training.…”

“…We evaluate effectiveness of this tailored IBI program for depression health promotion in subthreshold (to clinical) depression as part of a nationwide initiative from the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) aiming to prevent depression in green professions (i.e., agriculturists, foresters and horticulturists) in Germany. Overall, the depression prevention initiative from SVLFG entails a portfolio of internet- and tele-based interventions being evaluated regarding their short- and long-term effectiveness and cost-effectiveness in several randomized controlled trials ( Braun et al, 2019 ; Terhorst et al, 2020 ; Thielecke et al, 2020 ). In addition, the internet- and tele-based interventions are implemented into routine care and evaluated regarding implementation success ( Bührmann et al, 2020 ; Freund et al, 2020 ).…”

Effect of non-surgical interventions on pain relief and symptom improvement in farmers with diseases of the musculoskeletal system or connective tissue: an exploratory systematic review based on randomized controlled trials

“…Therefore, it is becoming difficult to provide face-to-face, easyto-understand, and polite explanations to farmers to prevent the spread of infection. We have already identified the latest research protocols 50,51) that may provide new and pragmatic programs for farmers. As generations of farmers change, Internet and mobile-based interventions are frequently used worldwide.…”