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

Clinical and cost-effectiveness of indicated guided internet-based interventions for prevention of depression in green professions - PROD-A (Prevention Of Depression in Agriculturists)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014000
Enrollment
360
Registered
2018-04-09
Start date
2018-04-09
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subclinical depressive symptoms

Interventions

Group 1: 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 inte

Sponsors

Universität Ulm, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Public ContactLina Braun

Universität Ulm, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie

lina.braun@uni-ulm.de+49-(0)731/50 32814

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026