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(Cost-) Effectiveness of a guided internet-based preventive intervention for individuals with chronic pain in the green sector

(Cost-) Effectiveness of a guided internet-based preventive intervention for individuals with chronic pain in the green sector - PACT-A (Preventive Acceptance and Commitment Therapy for chronic Pain in Agriculturists)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014619
Enrollment
286
Registered
2018-04-16
Start date
2018-04-30
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

Chronic pain

Interventions

Group 1: Intervention group: The intervention is an online prevention program based on the Acceptance and Commitment Therapy (ACT). The program is structured in seven weekly sessions. In the first s

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 • 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

MeasureTime frame
Primary outcome is pain interference (MPI) 9 weeks after randomization.

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: • 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

Public ContactLina Braun

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

lina.braun@uni-ulm.de+49-(0)731/50 328 14

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026