About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

75 Participants

are divided into 2 treatment groups

Group A: First standardized, second personalized CBTExperimental treatment 2 interventions

Group B: First personalized, second standardized CBTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

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

Other outcomes

1

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.

Time frame

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

2

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".

Time frame

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

3

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.

Time frame

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

4

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.

Time frame

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

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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