subclinical depressive symptoms
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Universität Ulm, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie