About this trial
Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for chronic primary pain (CPP), but overall effect sizes are small to moderate. Process orientation, personalization, and data-driven clinical decision-making may be able to address the heterogeneity among people with CPP and are thus promising ways to increase the effectiveness of CBT for CPP. In a previous study, the feasibility of personalized CBT for CPP using network analysis was investigated. Based on this work, the present study aims to compare this personalized CBT with a standardized CBT as treatment-as-usual condition.
In a balanced repeated measures design, a personalized CBT intervention is compared with a standardized CBT intervention. Participants are patients with CPP in German outpatient clinics. Primary and secondary outcome measures (disability, treatment expectations, pain intensity, working alliance, and side effects) will be collected after each study period. In addition, a SCED with randomized baselines will be embedded in the study, in which changes in processes relevant to chronic pain will be evaluated.
Eligibility criteria
Qualifiers
main diagnosis of chronic pain (i.e. pain persists for at least 6 months and is the most prominent/most burdensome symptom)
subjective impairment/disability (yes-no)
access to a smartphone compatible with the app mPath
Disqualifiers
acute hazard due to suicidality, substance abuse, and/or psychosis
only migraine/headache or migraine/headache are the focus of pain
analphabetism
insufficient German knowledge
Trial design
Treatments tested in this trial
- personalized Cognitive Behavior Therapy including third-wave
- standardized Cognitive Behavior Therapy including third-wave
Treatment groups
Sponsors and collaborators
Prof. Dr. Julia Glombiewski
Lead sponsor
University of Kaiserslautern-Landau
Sponsor institution