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RECRUITING
NCT06784141
NA

Network-Based vs. Standardized Cognitive Behavioral Therapy in Chronic Primary Pain

Sponsor: Prof. Dr. Julia Glombiewski

View on ClinicalTrials.gov

Summary

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.

Official title: Network-Based vs. Standardized Cognitive Behavioral Therapy in Chronic Primary Pain: A Single-Case Experimental Design With Randomized Baselines

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-04

Completion Date

2027-04

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

BEHAVIORAL

personalized Cognitive Behavior Therapy including third-wave

In the personalized CBT, patients first complete 21 days of EMA with six assessment points daily to assess relevant processes of CPP models. Person-specific networks are estimated based on the EMA data. A network-based algorithm indicates the treatment target. The individual CBT modules are selected for the participants from a matching matrix that contains experts' module recommendations for specific treatment targets. After that, participants will receive one out of ten CBT modules addressing their treatment target. All treatment modules are based on evaluated treatment manuals and contain methods from Cognitive Behavior Therapy, Acceptance and Commitment Therapy or Mindful Selfcompassion.

BEHAVIORAL

standardized Cognitive Behavior Therapy including third-wave

The standardized CBT intervention is manual-based and contains five sessions of cognitive behavioral therapy. Based on the evaluated manual from EFFECT Back, a short version with 5 modules is used: attention control, relaxation techniques, behavioral activation, cognitive strategies, and consolidation.

Locations (1)

RPTU Kaiserslautern-Landau, Klinische Psychologie und Psychotherapie des Erwachsenenalters

Landau, Germany