NCT06784141

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Prof. Dr. Julia Glombiewski · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesis: Personalized CBT will achieve a comparable treatment effect to the standardized CBT condition, i.e. a stronger reduction in the outcome measures (intercept and slope). Participants: Recruitment takes place at selected university outpatient clinics throughout Germany. Patients will be recruited via the waiting list of the university's outpatient clinic, in cooperation with other currently running studies at the same university recruiting chronic pain patients, and via various media (e.g. newspaper articles) and doctors' offices. Study therapists will be recruited in the university's outpatient clinic as well. Inclusion criteria for patients are at least 18 years of age, having access to a smartphone, and the main diagnosis of chronic pain. The diagnosis will be checked using the brief version of the Diagnostic Interview for Mental Disorders (Mini-DIPS). For patients recruited via the waiting list, screening for suitability will take place during the first consultation at the university psychotherapy training center's outpatient clinic. Suitable participants will be informed about the study and referred if they agree to be contacted. Furthermore, patients that had to be excluded from other currently running studies will be referred if they agreed to be contacted as well. Procedure \& Measures: Counterbalanced Repeated Measures Design: At this level, the primary outcome measure is pain disability index (PDI) and the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). Therapeutic alliance (Helping Alliance Questionnaire (HAQ), Working Alliance Inventory Short Revised (WAI-R); both therapist and patient version) and side effects (Negative Effects Questionnaire, NEQ) as well as expectations (Patient Questionnaire on Therapy Expectation and Evaluation, PATHEV) are collected as secondary outcome variables. These are collected before and after the diagnostic phase (A), after both interventions (C1, C2) and at follow-up (3 months). The HAQ, WAI-R, and NEQ constitute exceptions in this context. As these instruments pertain to the therapeutic relationship or the overall therapy process, they are not administered prior to the diagnostic phase, since no therapeutic contact has yet taken place. In addition, the therapist's case concept and a Perceived Causal Network (PECAN) of the therapist are collected after the diagnostic phase. Additional outcome measures are collected before the diagnostic phase (A), before the 3th baseline (B3) and at follow-up. As additional outcome measures the Depression Anxiety Stress Scale (DASS-21), the German Pain Solutions Questionnaire (PaSol), the Patient Global Impression of Change (PGIC) and Pain Self-Efficacy Questionnaire will be assed. SCED: The participants begin with the standard diagnostic phase of routine clinical care (phase B, 5 sessions) with psychoeducation and the development of therapy goals. After a randomized baseline (phase A1, 1-3 weeks), the intervention phase (phase C) begins. Participants are randomly assigned to one of two groups. Group 1 begins with personalized CBT followed by standardized CBT whereas Group 2 begins with standardized CBT followed by personalized CBT. A second baseline takes place in both groups after the first intervention before the beginning of the second intervention (A2, randomized 1-3 weeks). After the two different therapeutic phases, another baseline (A3, 2 weeks) and afterwards an EMA phase of 3 weeks will be completed. In addition, there are two booster sessions with the therapist one and three months after the last therapy session. During the EMA phases, data will be collected 6 times per day. In all other phases, the questionnaires are asked 3 times a week. Analysis: To evaluate group differences, a multilevel analysis (MLM) is calculated to take the nested data structure into account. The effects within the individual participant are calculated at level 1 and across the participants at level 2. To determine the required sample size, we performed a data simulation assuming a normal distribution with two predictors in the MLM: Treatment and order of treatment. The simulation revealed that a sample size of 59 participants is required, with a power of 0.80 aimed for to detect small effect sizes. Based on the dropout rate observed in a previous pilot study, a sample size of N = 75 is planned. The Bayes Factor and visual analysis are used to continuously evaluate the intervention effect at the individual level. In the visual analysis, we look at level, trend, variability, immediacy, overlap, and consistency.

Conditions

• Chronic Primary Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-01-20
• Last updated: 2025-05-01

Locations

1 site across 1 country: Germany