Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial

Abstract

Background People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+). Methods A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6–8 modules, duration: 6–8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants’ symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach. Discussion This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness. Trial registration German Clinical Trial Registration: DRKS00014000. Registered on 09 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)

“…Secondary outcomes are measured 9-week (T1), 6- (T2), 12- (T3), 24- (T4), and 36 months (T5) post-randomization. A detailed overview can be found in the corresponding study protocol ( Braun et al, 2019 ). This article focuses on the 6- and 12-month FU results, while effectiveness results at T1 were already reported ( Braun et al, 2021 ).…”

“…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 ).…”

Implementing internet- and tele-based interventions to prevent mental health disorders in farmers, foresters and gardeners (ImplementIT): study protocol for the multi-level evaluation of a nationwide project

“…The study aims to evaluate the implementation of tailored IMIs and a personalised telebased coaching as an extension to existing face-to-face group interventions. In addition to the implementation study, it is evaluated in parallel running, randomised controlled trials whether the internet-and tele-based interventions are (cost-)effective in reducing depressive symptoms and other mental health concerns as well as in preventing the onset of clinical depression in this specific target group of farmers, gardeners and foresters [40,41]. 1…”

“…The training of the e-coaches consists of supervision by licensed psychotherapists in CBT training and information about IT-matters. A detailed description is published in the study protocols elsewhere [40,[75][76][77][78][79][80].…”

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

“…Participants are excluded if they (a) receive an on-going psychotherapeutic treatment, (b) are not able to distance themselves from suicidal ideation (not able to sign a non-suicide contract) and (c) if they are eligible for the parallel clinical trial PROD-A and would instead prefer to participate in it. 46 See figure 1 for a study flow chart. Inclusion and exclusion criteria are assessed in a self-report online survey, in which applicants’ eligibility will be assessed prior to the trial inclusion and randomisation.…”