Thielecke Janika, Buntrock Claudia, Titzler Ingrid, Braun Lina, Freund Johanna, Berking Matthias, Baumeister Harald, Ebert David D
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Front Psychiatry. 2020 Mar 4;11:125. doi: 10.3389/fpsyt.2020.00125. eCollection 2020.
Farmers show high levels of depressive symptoms and mental health problems in various studies. This study is part of a nationwide prevention project carried out by a German social insurance company for farmers, foresters, and gardeners (SVLFG) to implement internet- and tele-based services among others to improve mental health in this population. The aim of the present study is to evaluate the (cost-)effectiveness of personalized tele-based coaching for reducing depressive symptom severity and preventing the onset of clinical depression, compared to enhanced treatment as usual. In a two-armed, pragmatic randomized controlled trial ( = 312) with follow-ups at post-treatment (6 months), 12 and 18 months, insured farmers, foresters, and gardeners, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) will be randomly allocated to personalized tele-based coaching or enhanced treatment as usual. The coaching is provided by psychologists and consists of up to 34 tele-based sessions for 25-50 min delivered over 6 months. Primary outcome is depressive symptom severity at post-treatment. Secondary outcomes include depression onset, anxiety, stress, and quality of life. A health-economic evaluation will be conducted from a societal perspective. This study is the first pragmatic randomized controlled trial evaluating the (cost-)effectiveness of a nationwide tele-based preventive service for farmers. If proven effective, the implementation of personalized tele-based coaching has the potential to reduce disease burden and health care costs both at an individual and societal level. German Clinical Trial Registration: DRKS00015655.
在各项研究中，农民群体呈现出较高水平的抑郁症状和心理健康问题。本研究是德国一家面向农民、林农和园艺工人的社会保险机构（SVLFG）开展的全国性预防项目的一部分，该项目旨在实施包括互联网和电话服务在内的多种服务，以改善这一群体的心理健康状况。本研究的目的是评估与强化常规治疗相比，个性化电话辅导在减轻抑郁症状严重程度和预防临床抑郁症发作方面的（成本）效益。在一项双臂实用随机对照试验（n = 312）中，对接受治疗后（6个月）、12个月和18个月进行随访，将有抑郁症状加重（PHQ-9≥5）的参保农民、林农、园艺工人、合作家庭成员和退休人员随机分配到个性化电话辅导组或强化常规治疗组。辅导由心理学家提供，包括在6个月内进行的多达34次、每次25 - 50分钟的电话辅导课程。主要结局是治疗后的抑郁症状严重程度。次要结局包括抑郁症发作、焦虑、压力和生活质量。将从社会角度进行健康经济学评估。本研究是第一项评估全国性针对农民的电话预防服务（成本）效益的实用随机对照试验。如果被证明有效，实施个性化电话辅导有可能在个人和社会层面减轻疾病负担和医疗保健成本。德国临床试验注册号：DRKS00015655。
