Chronic pain
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 • Chronic pain (duration >= 6 months; CPG >= Grade II) • Internet access • Informed consent
Exclusion criteria
Exclusion criteria: • Current psychotherapeutic treatment • Indication for at least subthreshold depression and preference for participation in a parallel clinical study focusing on prevention of depression (PROD-A: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014000) • 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 pain interference (MPI) 9 weeks after randomization. | — |
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: • Pain interference (MPI, BPI): T2-T5 • Pain intensity: T1-T5 • Perceived improvement: T2-T5 • Depressive symptom severity (QIDS-SR16): T1-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 (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 • Perceived stress (PSS-10): T1-T5 • Severity of insomnia (ISI): T1-T5 • Chronic pain Acceptance (CPAQ):T1-T5 • Cognitive Defusion (CFQ): T1-T5 • Committed action (CAQ): T1-T5 • Problematic alcohol consumption (AUDIT): T1-T5 • Pain intensity (NRS): T1-T5 • Quality of Life (AQoL-8D): T1-T5 • Negative effects of psychotherapy (INEP): T1-T3 • Therapeutic relationship (WAI-SR, WAI-SRT): T1, T3 • Technologic 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