A Mobile Intervention on Values in Chronic Pain Patients.

Study Overview
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Brief Summary
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The study aims to test a mobile intervention on values and goals in chronic pain patients. The cognitive behavioral intervention is a 10-day course in which participants complete a brief intervention each day (about 10-20 minutes a day). The content of the intervention includes the definition of values; development of individualized values and personal value-oriented goals; and implementation of personal goals in every day life. To assess the effectiveness of the intervention, we use a multiple baseline single case design. Baseline measurements will be assessed daily between 10 and 17 days (the exact number will be randomized). Daily measurements will continue during the intervention. After the intervention, another post measurement will be collected.

Official Title
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A Mobile Intervention on Values in Chronic Pain Patients.

Conditions
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Chronic Pain Syndrome

Intervention / Treatment
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* Behavioral: Mobile intervention on values and goals in patients with chronic pain.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic, non-tumor related back pain (pain for at least 6 months) Ownership of a smartphone Numeric Rating Scale for pain result of ≥ 4 Exclusion Criteria: High cognitive impairment (e.g., intellectual disability) Currently in psychotherapeutic treatment Initiation of pain-focused treatment during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single case analysis with 10-17 pre-measurement time points; 10 measurement time points during the intervention; and one post-measurement.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile based values intervention for people with chronic pain<br> | Behavioral: Mobile intervention on values and goals in patients with chronic pain.<br>* The protocol consists of 10 daily sessions, 10-20 Minutes each. After each session participants will complete daily measures. Participants will learn about values and a values based life. Further they will identify their own values and are encouraged to set a goal to pursue those values. Based on this, barriers to achieving goals are explained and a corresponding commitment will be made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain intensity | Numerical Pain Rating Scale (NPRS) Minimum value: 0; Maximum value: 10 (higher scores indicate higher pain intensity) | Pain intensity is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psychological well-being | The five-item WHO Well-Being Index (WHO-5) Minimum value: 0; Maximum value 10 (range is adapted for the study; higher scores indicate higher psychological well-being) | Psychological well-being is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points) | 
| Change in chronic pain acceptance | Chronic Pain Acceptance Questionnaire (CPAQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher pain acceptance) | Chronic Pain Acceptance is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points) | 
| Change in engaged living | Engaged Living Scale (ELS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher engaged living) | Engaged Living is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points) | 
| Change in pain catastrophizing | Pain Catastrophizing Scale (PCS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher catastrophizing) | Pain Catastrophizing is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points) | 
| Change in psychological flexibility | Acceptance and Action Questionnaire 2 (AAQ-2) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate lower psychological flexibility) | Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points) | 
| Change in self-efficacy | Pain Self-efficacy Questionnaire (PSEQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher self-efficacy) | Self-efficacy is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points) |