Reducing problematic alcohol use in employees: economic evaluation of guided and unguided web-based interventions alongside a three-arm randomized controlled trial.

AIMS: To perform an economic evaluation of guided and unguided internet-based interventions to reduce problematic alcohol consumption in employees compared with a waiting-list control condition (WLC) with unrestricted access to treatment-as-usual. DESIGN: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal and a cost-benefit analysis from the employer's perspective with a 6-month time horizon. SETTING: Open recruitment in the German working population. PARTICIPANTS: Employees (178 males, 256 females, mean age 47 years) consuming at least 14 (women) or 21 (men) standard units of alcohol (SUAs) per week and scoring ≥ 8 (men) or 6 (women) on the Alcohol Use Disorders Identification Test. MEASUREMENTS: On-line questionnaires administered to assess SUAs and assess quality of life (AQoL-8D) and resource use. Outcome measure was responder (≤ 14/≤ 21 SUAs) for the CEA and quality-adjusted life years (QALYs) for the CUA. Net benefit regression was used to estimate cost-effectiveness for each study arm. Bootstrapping and sensitivity analyses were performed to account for uncertainty. INTERVENTIONS: Five weekly modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation, provided with adherence-focused guidance [n = 142; responders: n = 73 (51.4%); QALYs = 0.364, standard error (SE) = 0.006] or without guidance [n = 146; n = 66 (45.2%); 0.359, 0.007]. Controls were on a waiting-list [n = 144; n = 38 (26.4%); 0.342, 0.007]. FINDINGS: From a societal perspective, the guided intervention had a probability of 55% (54%) of being the most efficient strategy at a willingness-to-pay (WTP) of €0 per responder (QALY) gained, compared with the unguided intervention and the control condition. At a WTP of €20 000 per QALY gained, the probability was 78%. From an employer's perspective, the guided intervention had a higher probability of a positive return on investment (81%) compared with the unguided intervention (58%). CONCLUSION: A guided internet-based intervention to reduce problematic alcohol consumption in employees appears to be both cost-beneficial and cost-effective.

Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.

BACKGROUND: Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions. METHODS: This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1. RESULTS: A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (ß=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low. LIMITATIONS: Results are limited to green professions and representativeness might be restricted by self-selection of participants. CONCLUSION: Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.

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.

INTRODUCTION: Chronic 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 ANALYSIS: A 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 DISSEMINATION: This 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 NUMBER: German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.

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).

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. Methods: In a two-armed, pragmatic randomized controlled trial (N = 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. 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. Clinical Trial Registration: German Clinical Trial Registration: DRKS00015655.

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.

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.

Exploring urban health in Cape Town, South Africa: an interdisciplinary analysis of secondary data.

BACKGROUND: With modern information technology, an overwhelming amount of data is available on different aspects of societies. Our research investigated the feasibility of using secondary data sources to get an overview of determinants of health and health outcomes in different population strata of Cape Town, a large city of South Africa. METHODS: The methodological approach of secondary-data analysis was similar in the different disciplines: Biological Anthropology, Public Health, Environmental Health, Mental Health, Palliative Care, Medical Psychology and Sociology at the University of Freiburg and Public Health at the University of Cape Town. The teams collected information on Cape Town through Internet searches and published articles. The information was extracted, analyzed, condensed, and jointly interpreted. RESULTS: Data show the typical picture of a population in epidemiological and demographic transition exposed to often difficult social, mental, and physical environmental conditions. Comparison between low and higher socioeconomic districts demonstrated that the former had higher air pollution, poorer water quality, and deficient sanitary conditions in addition to sub-optimal mental health services and palliative care. CONCLUSION: Although important information gaps were identified, the data draw attention to critical public health interventions required in poor health districts, and to motivate for pro-equity policies.