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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Primary Pain
• Intervention / Treatment: Behavioral: personalized Cognitive Behavior Therapy including third-wave; Behavioral: standardized Cognitive Behavior Therapy including third-wave

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saskia Scholten, PhD; Email: saskia.scholten@rptu.de
• Study Contact Backup: Name: Felicitas Kininger, M.Sc.; Phone Number: +49 6431 280-356-53; Email: f.kininger@rptu.de

Study Locations

• Germany
  • Landau, Germany
    • Recruiting
    • RPTU Kaiserslautern-Landau, Klinische Psychologie und Psychotherapie des Erwachsenenalters
    • Contact: Saskia Scholten, PhD; Email: saskia.scholten@rptu.de
    • Contact: Felicitas Kininger, M.Sc.; Email: f.kininger@rptu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First standardized, second personalized CBT; In this study arm, patients will first receive standardized and then personalized CBT. In the standardized CBT phase, a standardized CBT protocol will take place. In the personalized intervention phase, person-specific networks are estimated. A network-based algorithm indicates the treatment target. Participants will receive one out of ten CBT modules addressing their treatment target. A hybrid therapy option, i.e., partially online, will be available. The decision lies with the respective therapists and will be documented as a variable.	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.
Experimental: First personalized, second standardized CBT; In this study arm, patients will first receive standardized and then personalized CBT. In the personalized intervention phase, person-specific networks are estimated. A network-based algorithm indicates the treatment target. Participants will receive one out of ten CBT modules addressing their treatment target. In the standardized CBT phase, a manualized, standardized CBT will take place. A hybrid therapy option, i.e., partially online, will be available. The decision lies with the respective therapists and will be documented as a variable.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Disability Index (PDI)	The Pain Disability Index assesses the daily disability caused by pain in seven areas: family/domestic duties, recovery, social activities, work, sexuality, self-care, and life-sustaining activities. It has shown to be a valid instrument, displaying moderate test-retest reliability. Each item ranges from 0 to 10, with higher values indicating a greater disability due to pain.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	A shorter version consisting of only twelve questions was developed based on the WHODAS 2.0. This abbreviated version also covers all six health domains, including two questions on a 5-point-scale per domain, with higher values indicating a greater disability due to pain.. During its development, it was demonstrated that the WHODAS 2.0 exhibits high internal consistency, strong test-retest reliability, and high validity in comparison with other instruments.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological Momentary Assessment questionnaire	Throughout the whole study, the same questionnaire developed and in-evaluation for the use in Ecological Momentary Assessment will be applied. It assesses several therapy-relevant pain processes derived from common psychological models of chronic pain: catastrophizing, avoidance, depression (Fear-Avoidance model, Avoidance-Endurance model); thought suppression, task persistence, positive affect (Avoidance-Endurance model); acceptance, values (Psychological Flexibility); expectations (Predictive Coding); pain intensity, pain-related disability (Pain Experience); pain self-efficacy, self-compassion. The individual primary outcome will be the most relevant process for each participant according to the network from the first baseline. The items are rated on a scale from 0 to 10, with higher values indicating a worse outcome.	from baseline to the end of the post-EMA (an expected average of 27 weeks)
Working Alliance Inventory - Short Revised (WAI-SR)	The WAI-SR measures the therapeutic alliance with three scales of four items each: attachment, agreement with the therapeutic approach, and therapeutic goals. There is a patient version (WAI-SR-P) and a therapist version (WAI-SR-T). The WAI-SR shows good reliability (α > 0.80) and convergent validity with the Helping Alliance Questionnaire (r > 0.64). The items are rated on a scale of 1 to 5, with higher values indicating a stronger therapeutic alliance.	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)
Helping Alliance Questionaire (HAQ)	The HAQ is a 12-item instrument designed to assess the therapeutic relationship and process variables. Total scores and two subscale scores on patient relationship satisfaction and success satisfaction can be calculated. The items are rated on a scale of 1 to 6, with higher scores indicating a stronger therapeutic alliance. It can be completed by both the patient and the therapist. The reliability and validity analyses showed satisfactory to good values in all areas.	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)
Pain Intensity	Pain Intensity will be measured on an 11-point numerical analogue scale over a period of 24 hours. The value 0 represents no pain, the maximum value 10 represents maximum possible pain.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Negative Effects Questionnaire (NEQ)	The NEQ is an instrument for investigating negative effects in psychological treatments. The 20-item version of the NEQ shows comparable validity and reliability and uses a 5-point Likert-scale, with higher values indicating a stronger negative therapeutic effect.	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)
Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV)	The PATHEV consists of three subscales: Hope of Improvement, Fear of Change, and Suitability. The reliability of the scales is good to sufficient. The questionnaire contains 11 items with a 5-point scale.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
German Pain Solutions Questionnaire (PaSol)	The German version of the Pain Solutions Questionnaire assesses different coping strategies for pain with 14 items on a 7-point scale, with higher values indicating an improvement: solving pain, meaningfulness of life despite pain, acceptance of the insolubility of pain, and belief in a solution. It displays good reliability and validity and is sensistive for change.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Patient Global Impression of Change (PGIC)	One item will be used to assess subjective treatment effects with the Patient Global Impression of Change. It will be answered on a 7-point scale, ranging from "no change" to "very much better".	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Pain Self-Efficacy Questionnaire	The Pain Self-Efficacy Questionnaire contains on 10 items using a 7-point scale, with higher values indicating an improvement. It was tested regarding comprehensibility and displays high reliability and validity. It also is sensitive to change.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)
Depression Anxiety Stress Scale (DASS-21)	The DASS is a 42-item self report instrument and measures the three related negative emotional states of depression, anxiety and tension/stress and includes 7 items from each of the 3 subscales. The items are rated on a scale from 0 to 3, with higher values indicating stronger symptoms of depression, anxiety or stress. The internal consistency and concurrent validity were in acceptable to excellent ranges.	From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)

Collaborators and Investigators

• Sponsor: Prof. Dr. Julia Glombiewski

Publications and helpful links

General Publications

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Helpful Links

• Preregistration of the algorithmic decision-tool
• Preregistration of the EMA questionnaire development
• Assessment app mPath
• Preregistration of the feasibility study POINT Pain

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Pain; Cognitive Behavior Therapy; Ecological Momentary Assessment; Single Case Experimental Design; Network Analysis
• Other Study ID Numbers: POINT Pain 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No