Personalising Psychotherapy for Chronic Primary Pain Using Network Analysis

NCT06179784 | Completed

• 1 other identifier: POINT Pain
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single case experimental design study with multiple baselines is to use network analysis to personalise cognitive behaviour therapy for chronic primary pain (CPP) and base the selection of individual treatment targets and interventions on data to avoid cognitive biases of the clinicians. The main questions it aims to answer are:

• Is the study procedure accepted by and feasible for CPP patients as well as their therapists?
• Does the personalised psychotherapy with databased clinical decisionmaking lead to significant improvement? Participants will go through several study phases:
• Pretest and informational meeting with study management
• Baseline 1: answering a questionnaire six times a day for 21 days in daily life on their mobilephone (EMA); this data will be used for the calculation of a network for each participant, that in turn will be used to select the treatment target and according treatment intervention as suggested by an algorithmic decisiontool
• Probatory therapy phase: three weekly sessions with therapist; questionnaire three times a week
• Baseline 2: questionnaire three times a week
• Therapy phase: up to ten sessions with therapist; questionnaire three times a week
• Post phase: posttest, two weeks of three weekly assessments, then another 21 days EMA; two monthly booster sessions with therapist
• Follow-up: posttest and meeting with study management

Conditions

Chronic Primary Pain

Keywords

Chronic Pain; Single Case Experimental Design; Ecological Momentary Assessment; Network analysis; Cognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (3)

• 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: catastrophising, avoidance, depression (Fear-Avoidance model, Avoidance-Endurance model); thought supression, task persistence, positive affect (Avoidance-Endurance model); acceptance, values (Psychological Flexibility); expectations (Predictive Coding); pain instenisty, pain-related disability (Pain Experience); pain self-efficacy, sleep disturbance, self-compassion. The individual primary outcome will be the most relevant process for each participant according to the network from the first baseline.

  pre-intervention (two baselines), during intervention (on average 10 weeks + 3 weeks probatory phase), directly after intervention (2 weeks + 21 days)

• 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.

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

• Quebec Back Pain Disability Scale (QBPDS)

  The Quebec Back Pain Disability Scale will be adapted for chronic pain in general in this study. It assesses disability caused by pain in 20 activities relevant to everyday life. It displays sufficient validity and reliability.

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

Secondary Outcomes (6)

• Pain Intensity

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

• Short-Form McGill Pain Questionnaire (SF-MPQ)

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

• German Pain Solutions Questionnaire (PaSol)

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

• Patient Global Impression of Change (PGIC)

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

• Pain Self-Efficacy Questionnaire

  Pre-intervention, Post-intervention (directly after intervention), Follow-up (on average three months after intervention)

Study Arms (10)

Exposure in vivo

EXPERIMENTAL

The goal of the exposure in vivo treatment module is the correction of irrational, fearful beliefs regarding movements, a reduction of avoidance behaviours and hence a facilitation of activity levels. This will be done by carrying out feared, avoided movements and seeking out avoided situations and places. Exemplary units are the development of a movement hierarchy and protocols for exposure exercises.

Behavioral: Cognitive Behaviour Therapy including third-wave

Relaxation

EXPERIMENTAL

Goal of the relaxation treatment module is the reduction of stress and tension, which will be achieved applying relaxation techniques such as Progressive Muscle Relaxation (PMR), breathing techniques, and imaginary methods.

Behavioral: Cognitive Behaviour Therapy including third-wave

Activity and Rest

EXPERIMENTAL

The treatment module activity and rest is based on pacing and pursues the goal to balance active and resting phases. For overly active patients, the module will consist of implementing breaks and resting phases, while for overly resting patients the module will consist of graduated activity build-up. Acitivity protocols, plans, and exercises will be used.

Behavioral: Cognitive Behaviour Therapy including third-wave

Cognitive Coping with Pain

EXPERIMENTAL

Goal of the treatment module cognitive coping with pain is the reduction of rigid, dysfunctional thought patterns by flexibilising them and implement functional thought patterns instead. It includes classical methods such as cognitive restructuring as well as meta-cognitive or defusion techniques.

Behavioral: Cognitive Behaviour Therapy including third-wave

Attention Control

EXPERIMENTAL

The goal of the treatment module attention control is to enable patients to willingly draw their attention towards other entities as their pain or perceive their pain in a non-judgmental way, thus improve their coping strategies and enhance functioning levels. Exemplary units are the anti-pain diary or the distraction alphabet.

Behavioral: Cognitive Behaviour Therapy including third-wave

Activating Resources

EXPERIMENTAL

The goal of the activating resources module is relief and a balance between unpleasant perceptions as pain and pleasent experiences. This will be achieved by reactivating lost resources and implementing new ones, e.g. social networks or hobbies. Exemplary units are the positive diary or focusing on healthy bodyparts.

Behavioral: Cognitive Behaviour Therapy including third-wave

Acceptance

EXPERIMENTAL

Goal of the acceptance module is the flexibilisation of thought patterns by regaining mental resources through givign up inner resistance against the pain. Patients will be supported in developing an accepting attitude towards their suffering using working units like the monster by the wayside or concluding a peace treaty with oneself.

Behavioral: Cognitive Behaviour Therapy including third-wave

Values and Values-based Action

EXPERIMENTAL

Goal of the treatment module values and values-based action is enhancing satisfaction with life and regaining action control. Patients will learn about their personal values and how they can align their actions with them. Exemplary units are sorting values, a value diary, or looking back on one's life.

Behavioral: Cognitive Behaviour Therapy including third-wave

Sleep

EXPERIMENTAL

Goal of the treatment module sleep is enhancing the subjective sleep quality and increase the feeling of recovery. Patients will learn about sleep hygiene, stimulus control, and imaginary techniques such as the inner feel-good place.

Behavioral: Cognitive Behaviour Therapy including third-wave

Selfcompassion

EXPERIMENTAL

Goal of the selfcompassion treatment module is the development of a benevolent, loving, and kind attitude towards oneself and one's suffering in order to enhance wellbeing and feelings of self-worth. Exemplary units are the selfcompassion break, writing a letter to oneself, or changing perspective.

Behavioral: Cognitive Behaviour Therapy including third-wave

Interventions

Cognitive Behaviour Therapy including third-wave BEHAVIORAL

All treatment modules are based on evaluated treatment manuals and contain methods from Cognitive Behaviour Therapy including methods from the third wave like Acceptance and Commitment Therapy or Mindful Selfcompassion.

Also known as: Acceptance and Commitment Therapy, Mindful Selfcompassion

Acceptance; Activating Resources; Activity and Rest; Attention Control; Cognitive Coping with Pain; Exposure in vivo; Relaxation; Selfcompassion; Sleep; Values and Values-based Action

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

Location

Related Publications (30)

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  PMID: 39627123 DERIVED

Related Links

• Preregistration of the algorithmic decision-tool
• Preregistration of the EMA questionnaire development
• Assessment app mPath

MeSH Terms

Conditions

Chronic Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: 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 if no adverse effects or long lasting non-response is observed. Only then can the participant be allocated to another treatment module.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 22, 2023
• Study Start: November 17, 2023
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

DE (1)