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AzTrials

Chronic Primary PainNCT06784141

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

A study testing personalized Cognitive Behavior Therapy including third-wave and standardized Cognitive Behavior Therapy including third-wave in people with Chronic Primary Pain, run by Prof. Dr. Julia Glombiewski at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Primary Pain
What is being tested?
personalized Cognitive Behavior Therapy including third-wave and standardized Cognitive Behavior Therapy including third-wave
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteGermany
Study dates
9 May 2025to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • RPTU Kaiserslautern-Landau, Klinische Psychologie und Psychotherapie des Erwachsenenalters

    Landau

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
personalized Cognitive Behavior Therapy including third-wave, standardized Cognitive Behavior Therapy including third-wave
Keywords
Chronic Pain, Single Case Experimental Design, Ecological Momentary Assessment, Network Analysis, Cognitive Behavior Therapy
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • personalized Cognitive Behavior Therapy including third-waveBehavioural

    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.

  • standardized Cognitive Behavior Therapy including third-waveBehavioural

    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.

Study groups in NCT06784141
Study groupRoleWhat they receive
First standardized, second personalized CBTExperimentalIn 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.
Receives: Behavioral: personalized Cognitive Behavior Therapy including third-wave; Behavioral: standardized Cognitive Behavior Therapy including third-wave
First personalized, second standardized CBTExperimentalIn 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.
Receives: Behavioral: personalized Cognitive Behavior Therapy including third-wave; Behavioral: standardized Cognitive Behavior Therapy including third-wave

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 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)

  1. 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.

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

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

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

  5. 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.

    Measured: 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)

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start9 May 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784141
Sponsor's protocol ID
POINT Pain 2
Status last verified
Oct 2026
First submitted
9 Jan 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hofmann VE, Glombiewski JA, Kininger F, Scholten S. How to personalise cognitive-behavioural therapy for chronic primary pain using network analysis: study protocol for a single-case experimental design with multiple baselines. BMJ Open. 2024 Dec 3;14(12):e089319. doi: 10.1136/bmjopen-2024-089319.

    PubMed 39627123

  • Vogt R, Haas J, Baumann L, Sander A, Klose C, Riecke J, Rief W, Bingel U, Maser D, Witthoft M, Kessler J, Zugaj MR, Ditzen B, Glombiewski JA. EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ("EFFECT-BACK"): study protocol for a randomized controlled trial. Trials. 2024 Mar 11;25(1):176. doi: 10.1186/s13063-024-08017-9.

    PubMed 38468293

  • Vogel F, Blanken TF, Burger J, Reichert J, Scholten S, Klintwall L. How perceived causal networks can complement case conceptualization, diagnostic classification, and data-based networks: An introduction to a method for constructing personalized networks. J Psychopathol Clin Sci. 2025 Oct;134(7):844-854. doi: 10.1037/abn0001036. Epub 2025 Aug 14.

    PubMed 40811099

  • Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.

    PubMed 21076562

  • Akerblom S, Perrin S, Rivano Fischer M, McCracken LM. Predictors and mediators of outcome in cognitive behavioral therapy for chronic pain: the contributions of psychological flexibility. J Behav Med. 2021 Feb;44(1):111-122. doi: 10.1007/s10865-020-00168-9. Epub 2020 Jul 8.

    PubMed 32642875

  • Williams ACC, Fisher E, Hearn L, Eccleston C. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007407. doi: 10.1002/14651858.CD007407.pub4.

    PubMed 32794606

  • Wright AGC, Woods WC. Personalized Models of Psychopathology. Annu Rev Clin Psychol. 2020 May 7;16:49-74. doi: 10.1146/annurev-clinpsy-102419-125032. Epub 2020 Feb 18.

    PubMed 32070120

  • Vlaeyen JWS, Crombez G. Behavioral Conceptualization and Treatment of Chronic Pain. Annu Rev Clin Psychol. 2020 May 7;16:187-212. doi: 10.1146/annurev-clinpsy-050718-095744. Epub 2019 Dec 10.

    PubMed 31821023

  • Wideman TH, Finan PH, Edwards RR, Quartana PJ, Buenaver LF, Haythornthwaite JA, Smith MT. Increased sensitivity to physical activity among individuals with knee osteoarthritis: relation to pain outcomes, psychological factors, and responses to quantitative sensory testing. Pain. 2014 Apr;155(4):703-711. doi: 10.1016/j.pain.2013.12.028. Epub 2013 Dec 28.

    PubMed 24378879

  • Beeckman M, Simons LE, Hughes S, Loeys T, Goubert L. A Network Analysis of Potential Antecedents and Consequences of Pain-Related Activity Avoidance and Activity Engagement in Adolescents. Pain Med. 2020 Feb 1;21(2):e89-e101. doi: 10.1093/pm/pnz211.

    PubMed 31498397

  • Liew BXW, Ford JJ, Briganti G, Hahne AJ. Understanding how individualised physiotherapy or advice altered different elements of disability for people with low back pain using network analysis. PLoS One. 2022 Feb 10;17(2):e0263574. doi: 10.1371/journal.pone.0263574. eCollection 2022.

    PubMed 35143552

  • Thompson EL, Broadbent J, Fuller-Tyszkiewicz M, Bertino MD, Staiger PK. A Network Analysis of the Links Between Chronic Pain Symptoms and Affective Disorder Symptoms. Int J Behav Med. 2019 Feb;26(1):59-68. doi: 10.1007/s12529-018-9754-8.

    PubMed 30377989

  • Borsboom D. A network theory of mental disorders. World Psychiatry. 2017 Feb;16(1):5-13. doi: 10.1002/wps.20375.

    PubMed 28127906

  • Anderson KO, Dowds BN, Pelletz RE, Edwards TW, Peeters-Asdourian C. Development and initial validation of a scale to measure self-efficacy beliefs in patients with chronic pain. Pain. 1995 Oct;63(1):77-83. doi: 10.1016/0304-3959(95)00021-J.

    PubMed 8577493

  • Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.

    PubMed 16446108

Questions about this trial

What is this clinical trial studying?

A study testing personalized Cognitive Behavior Therapy including third-wave and standardized Cognitive Behavior Therapy including third-wave in people with Chronic Primary Pain, run by Prof. Dr. Julia Glombiewski at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Disability Index (PDI) (time frame: From baseline to posttest (an expected average of 22 weeks) to Follow-up-Assessment (an expected average of 6 month after posttest)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784141, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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