Clinical trial NCT05205889: A Mobile Intervention on Values in Chronic Pain Patients.
Official title: A Mobile Intervention on Values in Chronic Pain Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Syndrome
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case analysis with 10-17 pre-measurement time points; 10 measurement time points during the intervention; and one post-measurement.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Pain intensity is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points)
Secondary outcomes:
measure: Change in psychological well-being
timeFrame: Psychological well-being is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points)
measure: Change in chronic pain acceptance
timeFrame: Chronic Pain Acceptance is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
measure: Change in engaged living
timeFrame: Engaged Living is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
measure: Change in pain catastrophizing
timeFrame: Pain Catastrophizing is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
measure: Change in psychological flexibility
timeFrame: Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
measure: Change in self-efficacy
timeFrame: Self-efficacy is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University of Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Winfried Rief, PhD
role: PRINCIPAL_INVESTIGATOR
References: