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A Mobile Intervention on Values in Chronic Pain Patients.

Primary Purpose

Chronic Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mobile intervention on values and goals in patients with chronic pain.
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Marburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile based values intervention for people with chronic pain

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain intensity
Numerical Pain Rating Scale (NPRS) Minimum value: 0; Maximum value: 10 (higher scores indicate higher pain intensity)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)

Full Information

First Posted
December 21, 2021
Last Updated
October 5, 2022
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05205889
Brief Title
A Mobile Intervention on Values in Chronic Pain Patients.
Official Title
A Mobile Intervention on Values in Chronic Pain Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
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.
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile based values intervention for people with chronic pain
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mobile intervention on values and goals in patients with chronic pain.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain intensity
Description
Numerical Pain Rating Scale (NPRS) Minimum value: 0; Maximum value: 10 (higher scores indicate higher pain intensity)
Time Frame
Pain intensity is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points)
Secondary Outcome Measure Information:
Title
Change in psychological well-being
Description
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)
Time Frame
Psychological well-being is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points)
Title
Change in chronic pain acceptance
Description
Chronic Pain Acceptance Questionnaire (CPAQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher pain acceptance)
Time Frame
Chronic Pain Acceptance is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
Title
Change in engaged living
Description
Engaged Living Scale (ELS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher engaged living)
Time Frame
Engaged Living is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
Title
Change in pain catastrophizing
Description
Pain Catastrophizing Scale (PCS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher catastrophizing)
Time Frame
Pain Catastrophizing is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
Title
Change in psychological flexibility
Description
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)
Time Frame
Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
Title
Change in self-efficacy
Description
Pain Self-efficacy Questionnaire (PSEQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher self-efficacy)
Time Frame
Self-efficacy is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Subjects can self-assign their gender.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, PhD
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35032
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data can be shared upon request.

Learn more about this trial

A Mobile Intervention on Values in Chronic Pain Patients.

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