Trial document




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  DRKS00014000

Trial Description

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Title

Clinical and cost-effectiveness of indicated guided internet-based interventions for prevention of depression in green professions

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Trial Acronym

PROD-A (Prevention Of Depression in Agriculturists)

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URL of the Trial

https://www.uni-ulm.de/in/psy-klips/forschung/forschung/e-mental-health-internet-und-mobile-basierte-interventionen/

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Brief Summary in Lay Language

Object of research: The present study evaluates indicated guided internet-based interventions for prevention of depression in green professions. Preventive interventions of the external service provider GET.ON are offered by a social insurance scheme in Germany (Sozialversicherung für Landwirtschaft, Forsten und Gartenbau, SVLFG) for their policyholders.

Background: Increasing pressure on agriculturists, foresters and horticulturists as well as employees in green professions is associated with growing psychological distress. Potential risk factors like heavy workload, financial worries, and lack of appreciation as well as planning uncertainties make occupational routine difficult. High psychological and physical strain in this occupational group can facilitate the development of depressive symptoms.
By early utilization of preventive services, subclinical depressive symptom severity could be reduced and progression towards a manifest clinical depression could be prevented. However, an ambivalence regarding preventive interventions probably prevailing in this population hinders the uptake of such interventions.
Internet-based interventions - based on principles of cognitive behavioral therapy - have been shown to be clinically effective and cost-effective in reducing subclinical depressive symptoms. Because internet-based interventions are easily accessible at any time and place they constitute a promising approach to reach affected individuals, especially in rural areas.

Aims: The aim of the present study is to evaluate the clinical and cost-effectiveness of internet-based interventions in reducing subclinical depressive symptoms and the incidence of clinically relevant depressive symptomology in agriculturists, foresters and horticulturists as well as employees in green professions.

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Brief Summary in Scientific Language

In this two-armed randomized controlled trial the clinical effectiveness and cost-effectiveness of six guided internet-based interventions are compared to treatment as usual (TAU+) in the agricultural sector over a period of 36 months. In total, 360 participants with at least subclinical depressive symptoms (PHQ-9 ≥ 5) will be recruited and randomized into the two study arms.

Participants in the intervention group receive one of six internet-based interventions for prevention of depression. The selection of an appropriate intervention is based on the baseline assessment of present symptoms as well as personal preferences in consultation with an e-coach. Participants in the control group will receive an online information letter with psycho-educative information about stress, depression and chronic pain as well as information about further treatment options in routine care.

Primary Outcome is depressive symptom severity (QIDS-SR16) at post-treatment. It will be investigated if a reduction in subclinical depressive symptoms can be achieved irrespectively of the specific focus of the internet-based interventions. Secondary Outcomes include incidence of clinical relevant depression (QIDS-SR16 ≥ 11), quality of life (AQoL-8D), cost-effectiveness (TiC-P), as well as potential negative effects (INEP) of interventions. The clinical and cost-effectiveness of the internet-based interventions will be evaluated over a period of 36 months (T0 Baseline, T1 Post - 9 weeks, T2 6-month follow-up (FU), T3 12-month FU, T4 24-month FU, T5 36-month FU). Details about study design will be published in a study protocol.

The present study will have major implications for the use of internet-based interventions for prevention of depression and for improving the offer of preventive health interventions in the agricultural sector. If clinical and cost-effectiveness can be shown, a nationwide implementation of this health care offer could reduce sick leave and associated direct and indirect health care costs in green professions. By offering a low-threshold and wide selection of internet-based interventions, their scope can be broadened and interventions can be provided based on patient preference.

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Organizational Data

  •   DRKS00014000
  •   2018/04/09
  •   [---]*
  •   yes
  •   Approved
  •   454/17, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   subclinical depressive symptoms
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Interventions/Observational Groups

  •   Intervention group: Selection of six guided, internet-based interventions consisting of 6-8 lessons (duration of a lesson: 30-60 minutes, duration of an online-training: 6-8 weeks):

    The intervention group receives one of six internet-based interventions targeting different problem areas depending on individual symptoms. Interventions should contribute to symptom reduction and counteract the development of clinical relevant depressive symptomology. This is achieved by focusing on treatment of depressive symptoms in general (GET.ON Mood Enhancer) or in the context of diabetes mellitus (GET.ON Mood Enhancer Diabetes), by improving sleep quality (GET.ON Recovery), or by reducing subjective stress load (GET.ON Stress), panic symptoms (GET.ON Panic), or problematic alcohol consumption (GET.ON Be smart - Drink less). Interventions are assumed to be effective irrespective of the specific focus on different problem areas due to general mechanisms of change across internet-based interventions.
    Following to completion of the online-training, a consolidating phase of 12 months follows. During this period, participants are contacted once a month by their individual e-coach. If participants still report psychological strain after completing the first online-training, it is possible to participate in another unguided online-training in agreement with the e-coach.

  •   Control group (TAU+): The control group will receive an online information letter with psycho-educative information about stress, depression and chronic pain. Additionally, information about further treatment options in standard care will be provided, e.g. information about an online freely available audio CD for stress reduction and a database with different health care services. Additionally, utilization of health care services will be continuously recorded as part of the accompanying health economic evaluation, so that a description of TAU+ can be provided post-hoc. The control group will not get access to internet-based interventions, but has unrestricted access to routine care.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is depressive symptom severity at post-treatment (9 weeks after randomization, T1). The primary endpoint will be measured with a self-report questionnaire Quick Inventory of Depressive Symptomology (QIDS-SR16).

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Secondary Outcome

Clinical and cost-effectiveness of internet-based interventions will be evaluated over a period of 36 months (T0 Baseline, T1 Post - 9 weeks, T2 6-month follow-up (FU), T3 12-month FU, T4 24-month FU, T5 36-month FU).

Secondary Outcomes:

• Depressive symptom severity at follow-up: T2 - T5
• Incidence of clinical relevant depressive symptomology (QIDS-SR16 ≥ 11) in subgroup without clinical relevant depression at T0: T1 - T5
• 12-month-prevalence of depression and bipolar disorder (CIDI-SC): T3 - T5
• Presence of suicidal ideation (suicidality items PHQ-9, QIDS-SR16, BDI-II): T1 - T5
• Severity of anxiety (GAD-7): T1 - T5
• Manifestation of panic disorder and/or agoraphobia (PAS): T1 - T5
• Perceived stress (PSS): T1 - T5
• Severity of insomnia (ISI): T1 - T5
• Problematic alcohol consumption (AUDIT): T1 - T5
• Pain intensity (NRS): T1 - T5
• Pain Interference (MPI): T1 - T5
• Emotional exhaustion (MBI-GS, subscale): T1 / T3
• Quality of life (AQoL-8D): T1 - T5
• Negative effects of psychotherapy (INEP, open questions): T1 - T3
• Therapeutic relationship (WAI-SR, WAI-SRT): T1, T3
• Technological alliance (TAI-OT): T1 - T2
• Subjective prognosis of employment (SPE): T1 - T5
• Direct and indirect costs (German adaptation of Trimbos / iMTA questionnaire for costs associated with psychiatric illness (TiC-P) including insurance data about utilization of health care services): T1 - T5
• Patient satisfaction with intervention (CSQ-I): T1

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/04/09
  •   360
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Agriculturists, foresters and horticulturists with a LAK- or LKK insurance status. The study is accessible for entrepreneurs, collaborating spouses and family members as well as elderly people, who do no longer contribute to the production process (“Altenteiler”) with LAK- or LKK-insurance status
• Presence of at least subclinical depressive symptoms (PHQ-9 >= 5)
• Internet access
• Informed consent

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Exclusion Criteria

• Current psychotherapeutic treatment
• Indication for chronic pain and preference for participation in a parallel clinical study about chronic pain (PACT-A)
• Increased suicidal risk (suicidality items PHQ-9 >=1 & BDI-II >=1 / suicidality items QIDS-SR16 >=1 & BDI-II >=1) and denial to sign a non-suicide contract

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Addresses

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    • Universität Ulm, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • D-89069  Ulm
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Friedrich-Alexander-Universität Erlangen-Nürnberg,
    • Mr.  PD Dr.  David Daniel  Ebert 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • Universität Ulm, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Harald  Baumeister 
    • Albert-Einstein-Allee 47
    • D-89069  Ulm
    • Germany
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    • Universität Ulm, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
    • Ms.  Lina  Braun 
    • Albert-Einstein-Allee 47
    • D-89069  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Sozialversicherung für Landwirtschaft, Forsten und Gartenbau (SVLFG), Hauptverwaltung
    • Weißensteinstraße 70 – 72
    • 34131  Kassel
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.