A Mobile Intervention on Values in Chronic Pain Patients.

NCT05205889 | Completed

• 1 other identifier: SCA0222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in 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 is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)

• Change in 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 is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)

• Change in psychological flexibility

  Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)

Study Arms (1)

Mobile based values intervention for people with chronic pain

EXPERIMENTAL

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

Interventions

Mobile intervention on values and goals in patients with chronic pain. BEHAVIORAL

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.

Mobile based values intervention for people with chronic pain

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subjects can self-assign their gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic, non-tumor related back pain (pain for at least 6 months)
• Ownership of a smartphone
• Numeric Rating Scale for pain result of ≥ 4

You may not qualify if:

• High cognitive impairment (e.g., intellectual disability)
• Currently in psychotherapeutic treatment
• Initiation of pain-focused treatment during the study

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

University of Marburg

Marburg, Hesse, 35032, Germany

Location

Study Officials

• Winfried Rief, PhD

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is required, as participants are fully informed about the purpose of the study. Since there is only one arm, masking of the investigators is also not necessary.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Jenny Riecke

Model Details: Single case analysis with 10-17 pre-measurement time points; 10 measurement time points during the intervention; and one post-measurement.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 25, 2022
• Study Start: February 15, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 31, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

DE (1)