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

NCT06784141 | Recruiting

• 1 other identifier: POINT Pain 2
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Primary Pain

Keywords

Chronic Pain; Single Case Experimental Design; Ecological Momentary Assessment; Network Analysis; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Ecological Momentary Assessment questionnaire

  from baseline to the end of the post-EMA (an expected average of 27 weeks)

• Working Alliance Inventory - Short Revised (WAI-SR)

  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)

  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

  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)

  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)

Other Outcomes (4)

• German Pain Solutions Questionnaire (PaSol)

  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)

  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

  From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)

Study Arms (2)

First standardized, second personalized CBT

EXPERIMENTAL

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; Behavioral: standardized Cognitive Behavior Therapy including third-wave

First personalized, second standardized CBT

EXPERIMENTAL

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; Behavioral: standardized Cognitive Behavior Therapy including third-wave

Interventions

personalized Cognitive Behavior Therapy including third-wave BEHAVIORAL

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.

First personalized, second standardized CBT; First standardized, second personalized CBT

standardized Cognitive Behavior Therapy including third-wave BEHAVIORAL

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.

First personalized, second standardized CBT; First standardized, second personalized CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Julia Glombiewski: lead

Study Sites (1)

RPTU Kaiserslautern-Landau, Klinische Psychologie und Psychotherapie des Erwachsenenalters

Landau, Germany

RECRUITING

Related Publications (35)

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Related Links

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

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Felicitas Kininger, M.Sc.

CONTACT

+49 6431 280-356-53; f.kininger@rptu.de

Saskia Scholten, PhD

CONTACT

Saskia.scholten@rptu.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor, Head of department clinical psychology and psychotherapy for adults

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

DE (1)