Clinical trial NCT06784141: Network-Based vs. Standardized Cognitive Behavioral Therapy in Chronic Primary Pain
Official title: Network-Based vs. Standardized Cognitive Behavioral Therapy in Chronic Primary Pain: A Single-Case Experimental Design With Randomized Baselines
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Primary Pain
Keywords: Chronic Pain
Single Case Experimental Design
Ecological Momentary Assessment
Network Analysis
Cognitive Behavior Therapy
Lead sponsor: University of Kaiserslautern-Landau
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are assigned to one of the two possible intervention sequences: personalized CBT first and then standardized CBT, or in reverse order. In the personalized CBT, the participants will be allocated to one out of ten treatment modules according to their most relevant pain process. The same module will be used for the whole therapy phase.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* current psychotherapy
* current participation in another intervention study
* physical inability to take part in therapy and study sessions

Primary outcomes:
measure: Pain Disability Index (PDI)
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Secondary outcomes:
measure: Ecological Momentary Assessment questionnaire
timeFrame: from baseline to the end of the post-EMA (an expected average of 27 weeks)
measure: Working Alliance Inventory - Short Revised (WAI-SR)
timeFrame: From the end of the diagnostic phase to posttest (an expected average of 17 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Helping Alliance Questionaire (HAQ)
timeFrame: From the end of the diagnostic phase to posttest (an expected average of 17 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Pain Intensity
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Negative Effects Questionnaire (NEQ)
timeFrame: From the end of the diagnostic phase to posttest (an expected average of 17 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV)
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Other outcomes:
measure: German Pain Solutions Questionnaire (PaSol)
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Patient Global Impression of Change (PGIC)
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Pain Self-Efficacy Questionnaire
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Locations:
city: Landau
country: Germany
facility: RPTU Kaiserslautern-Landau, Klinische Psychologie und Psychotherapie des Erwachsenenalters
Study officials:
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