R52 F32
Conditions
Interventions
Group 1: Intervention group with direct access (8 weeks) to the online self-help program "Lenio". “Lenio“includes 11 modules. They are interactively designed and address chronic pain and depressive sy
Sponsors
Deutsche Gesetzliche Unfallversicherung e.V. (DGUV)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: An ability to consent (informed consent), available internet access and a smartphone, sufficient understanding of the German language, willingness to participate in three anonymous online surveys, each lasting approximately 25-30min, willingness to participate in a 8-week training program, willingness to use the program at one's own responsibility, presence of chronic pain and depressive symptoms, presence of a desire for treatment, and willingness to leave an email address and receive emails twice a week. For the latter, instructions for creating a free and anonymous email address are provided.
Exclusion criteria
Exclusion criteria: The presence of lifetime schizophrenic or bipolar symptomatology, alcohol dependence, or acute suicidal tendencies are exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the numeric rating scale "pain impairment" (mean value of impairment in daily life, leisure time and work) of the German Pain Questionnaire (German acronym: DSF). The primary analysis refers to the difference values between baseline and post time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| PHQ-9 (Patient Health Questionnaire 9) to determine the severity of depressive symptoms in the past two weeks: Difference between baseline, post (after 8 weeks) and follow-up (after 16 weeks). BDI-II (Beck's Depression Inventory) to assess the severity of depression; difference between baseline, post (after 8 weeks) and follow-up (after 16 weeks). DSF (German Pain Questionnaire) to determine the severity of symptoms according to v. Korff (calculated from pain impairment and pain intensity); difference between pre, post (after 8 weeks) and follow-up (after 16 weeks). IEQ (Injustice Experience Questionnaire) to assess feelings of injustice as a result of chronic pain; difference between baseline and post (after 8 weeks) and follow-up (after 16 weeks). PCS (Pain Catastrophizing Questionnaire) to assess catastrophizing thinking patterns related to pain; difference between baseline and post (after 8 weeks) and follow-up (after 16 weeks) FABQ (Fear Avoidance Belief Questionnaire) to assess fear-related avoidance attitudes); difference between baseline and post (after 8 weeks) and follow-up (after 16 weeks) FSS (Pain Related Self-Introspection Questionnaire) to assess pain perception and pain coping; difference between baseline and post (after 8 weeks) and follow-up (after 16 weeks) WHOQOL-BREF (World Health Organization Quality of Life) to assess quality of life; difference between baseline and post (after 8 weeks) and follow-up (after 16 weeks) Positive and Negative Effects of Psychotherapy Scale for internet-based Interventions (PANEPS-I) to assess side effects of “Lenio”; at post (after 8 weeks) and follow-up (after 16 weeks) only. The University of Rhode Island Change Assessment Scale (URICA) to assess readiness for change; difference between baseline and post (after 8 weeks) and follow-up (after 16 weeks). Questionnaire to assess subjective evaluation of the training (ZUF-8); only at post (after 8 weeks) | — |
Countries
Germany
Contacts
Public ContactSwantje Borsutzky
Universitätsklinikum Hamburg-Eppendorf, Arbeitsgruppe Klinische Neuropsychologie
Outcome results
None listed