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.

Not Applicable

Completed

• Conditions: F32.0; F32.1; F33.0; F33.1; M40-M54; R52.1; R52.2; G50-G59; Mild depressive episode; Moderate depressive episode

• Registration Number: DRKS00007960
• Lead Sponsor: niversität Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-12
• Study Completion: 2018-09-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 295

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Online-Questionaires at baseline, 9-weeks post randomisation, 6 and 12 months after randomisation.<br><br>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)