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.

scholarly journals Cost-Effectiveness of Virtual Reality Cognitive Behavioral Therapy for Psychosis: Health-Economic Evaluation Within a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Roos Pot-Kolder ◽  
Wim Veling ◽  
Chris Geraets ◽  
Joran Lokkerbol ◽  
Filip Smit ◽  
...  
Keyword(s):  
Health Economic ◽  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Cost Effectiveness ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Paranoid Ideation ◽  
Randomized Controlled ◽  
Treatment Responder

BACKGROUND Evidence was found for the effectiveness of virtual reality-based cognitive behavioral therapy (VR-CBT) for treating paranoia in psychosis, but health-economic evaluations are lacking. OBJECTIVE This study aimed to determine the short-term cost-effectiveness of VR-CBT. METHODS The health-economic evaluation was embedded in a randomized controlled trial evaluating VR-CBT in 116 patients with a psychotic disorder suffering from paranoid ideation. The control group (n=58) received treatment as usual (TAU) for psychotic disorders in accordance with the clinical guidelines. The experimental group (n=58) received TAU complemented with add-on VR-CBT to reduce paranoid ideation and social avoidance. Data were collected at baseline and at 3 and 6 months postbaseline. Treatment response was defined as a pre-post improvement of symptoms of at least 20% in social participation measures. Change in quality-adjusted life years (QALYs) was estimated by using Sanderson et al’s conversion factor to map a change in the standardized mean difference of Green’s Paranoid Thoughts Scale score on a corresponding change in utility. The incremental cost-effectiveness ratios were calculated using 5000 bootstraps of seemingly unrelated regression equations of costs and effects. The cost-effectiveness acceptability curves were graphed for the costs per treatment responder gained and per QALY gained. RESULTS The average mean incremental costs for a treatment responder on social participation ranged between €8079 and €19,525, with 90.74%-99.74% showing improvement. The average incremental cost per QALY was €48,868 over the 6 months of follow-up, with 99.98% showing improved QALYs. Sensitivity analyses show costs to be lower when relevant baseline differences were included in the analysis. Average costs per treatment responder now ranged between €6800 and €16,597, while the average cost per QALY gained was €42,030. CONCLUSIONS This study demonstrates that offering VR-CBT to patients with paranoid delusions is an economically viable approach toward improving patients’ health in a cost-effective manner. Long-term effects need further research. CLINICALTRIAL International Standard Randomised Controlled Trial Number (ISRCTN) 12929657; http://www.isrctn.com/ISRCTN12929657

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