A Mobile Intervention on Values in Chronic Pain Patients.

Chronic Pain Syndrome Clinical Trial

Official title:

A Mobile Intervention on Values in Chronic Pain Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205889
• Other study ID #: SCA0222
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2022
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

Behavioral:
• Mobile intervention on values and goals in patients with chronic pain.
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.

Locations

Country	Name	City	State
Germany	University of Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)