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Effectiveness and cost-efficacy of an internet-based intervention for the prevention of major depression in patients with back pain and subthreshold depression - a randomized controlled trial. EK-confirmed substudy of "Effectiveness of a guided web-based intervention for depression in back pain rehabilitation aftercare."

Effectiveness and cost-efficacy of an internet-based intervention for the prevention of major depression in patients with back pain and subthreshold depression - a randomized controlled trial. EK-confirmed substudy of "Effectiveness of a guided web-based intervention for depression in back pain rehabilitation aftercare." - PROD-BP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007960
Enrollment
406
Registered
2015-08-12
Start date
2015-10-21
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

F32.0 F32.1 F33.0 F33.1 M40-M54 R52.1 R52.2 G50-G59

Interventions

Group 1: Online-Training RückCare-P The intervention is based on Cognitive Behavioral Therapy (CBT) including 6 weekly plus three optional modules and two booster sessions after end of intervention. T

Sponsors

Universität Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Those who signed the informed consent form will be included in the study if they meet the following criteria: a) age 18 and above, b) presence of back pain, c) sufficient knowledge of German language, d) medically suitable, e) adequate computer and internet skills for an internet-based depression intervention, f) internet access, g) depressive symptomatology (Patient Health Questionnaire = 5).

Exclusion criteria

Exclusion criteria: Patients will be excluded who meet DSM-IV criteria for a) current depressive episode or b) a bipolar disorder. Additionally patient will be excluded in case of c) an ongoing psychotherapy, respectively being on a waiting list for psychotherapy, d) being suicidal or reporting suicidal acts in history.

Design outcomes

Primary

MeasureTime frame
Onset of depression measured by the telephone-administered Structured Clinical Interview for DSM-IV (SCID) within one year after randomisation.

Secondary

MeasureTime frame
Online-Questionaires at baseline, 9-weeks post randomisation, 6 and 12 months after randomisation. Depressive symptomatology (PHQ-9, HAM-D), Quality of life (EQ-5D), Pain intensity (Rating scale), Pain related disability (ODI), Pain self-efficacy (PSEQ), Work capacity (SPE), Patient satisfaction (CSQ-8), Costs (TiC-P), Side-effects of intervention (INEP), Intervention attitudes (ATSPPH-SF)

Countries

Germany

Contacts

Public ContactLasse Sander

Universität Freiburg, Abteilung Rehabilitationspsychologie und Psychotherapie

lasse.sander@psychologie.uni-freiburg.de00497612033049

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 11, 2026