F45.40 F45.41 M54
Conditions
Interventions
Group 1: Intervention group: 12 weeks of unaccompanied online self-help for chronic pain using the Selfapy GmbH course.
Group 2: Waiting control group with delayed access to Selfapy for Chronic Pain (
Sponsors
Selfapy GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Chronic pain with localization in the back that meets the criteria for one of the following indications according to ICD-10: - M54.-: Back pain - F45.40: Persistent somatoform pain disorder - F45.41: Chronic pain disorder with psychological and somatic factors - Duration of pain: at least 3 months - Chronic severity of at least level 1 on the von Korff scale (von Korff & Ormel, 1992). - Sufficient knowledge of the German language - Sufficient computer and Internet skills - Internet access.
Exclusion criteria
Exclusion criteria: - Pain due to an acute tumor - Acute suicidal tendency - Planned surgery within the next 3 months - Current psychotherapy at the beginning of the course if the focus is on chronic pain management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain-related everyday life impairment: West Haven-Yale Multidimensional Pain Inventory interference scale (German version; MPI-D; Flor et al., 1990), measured at baseline (T0), after 6 weeks (intermediate status measurement; ZS), and final survey after 12 weeks (T1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmatory - Quality of life: Veterans RAND 12-Item Health Survey (VR-12 in German translation; Buchholz et al., 2021). - Pain intensity: numeric rating scale (NRS; compare Turk et al., 2003). - Depressive symptoms: Depression module of the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001). - Anxiety symptoms: German version of the Generalized Anxiety Disorder 7-item scale from the Health Questionnaire for Patients (GAD-7; Löwe et al., 2008). - Stress symptoms: 12-item screening scale from the Trier Inventory for the Assessment of Chronic Stress (TICS-SSCS; Schulz, Schlotz & Becker, 2004). Exploratory: - Catastrophizing of pain (Pain Catastrophizing Scale; PCS). - Tendency to avoid pain (Fear-Avoidance Beliefs Questionnaire; FABQ-D) - Acceptance of chronic pain (Chronic Pain Acceptance Questionnaire; CPAQ-D) Additional analyses - Overall impression of the participant(s) (Patients' Global Impression of Change Scale; PGIC) - Side effects of the intervention (Negative Effects Questionnaire; NEQ) Patient satisfaction (Patient Satisfaction Questionnaire; ZUF-8), additional single item) - Exposure to medical pain treatment, medication adjustment, critical life events - Adherence - Reason for discontinuation | — |
Countries
Germany
Contacts
Public ContactLea Prengel
Humboldt-Universität zu Berlin
Outcome results
None listed