scholarly journals Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial

2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Tanja van der Zweerde ◽  
Jaap Lancee ◽  
Pauline Slottje ◽  
Judith Bosmans ◽  
Eus Van Someren ◽  
...  
Keyword(s):  
General Practice ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled

scholarly journals 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

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Lina Braun ◽  
Ingrid Titzler ◽  
David Daniel Ebert ◽  
Claudia Buntrock ◽  
Yannik Terhorst ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Large Scale ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Depressive Mood ◽  
Trial Registration ◽  
Depression Prevention ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled

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.

scholarly journals Clinical and cost-effectiveness of personalized tele-based coaching for farmers, foresters and gardeners to prevent depression: Study protocol of an 18-month follow-up pragmatic randomized controlled trial (TEC-A)

2019 ◽  
Author(s):  
Janika Thielecke ◽  
Claudia Buntrock ◽  
Ingrid Titzler ◽  
Lina Braun ◽  
Johanna Freund ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Depressive Symptom ◽  
Cost Effectiveness ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Depressive Symptom Severity ◽  
The Cost

Background: 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 (TAU+ ).Methods: In a two-armed, pragmatic randomized controlled trial (N=312) with follow-ups at post-treatment (6 months), 12 months 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 TAU+. The coaching is provided by psychologists and consists of up to 34 tele-based sessions for 25 to 50 minutes 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. Discussion: 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.

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