A Mobile Intervention on Values in Chronic Pain Patients.

• Sponsor: Philipps University Marburg Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05205889
• Collaborator: (none)
• Enrollment: 40
• Arm: 1
• Anticipated Duration (Months): 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Syndrome	Behavioral: Mobile intervention on values and goals in patients with chronic pain.	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single case analysis with 10-17 pre-measurement time points; 10 measurement time points during the intervention; and one post-measurement.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.
• Primary Purpose: Treatment
• Official Title: A Mobile Intervention on Values in Chronic Pain Patients.
• Anticipated Study Start Date: Feb 15, 2022
• Anticipated Primary Completion Date: Mar 31, 2022
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Mobile based values intervention for people with chronic pain

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.

Outcome Measures

Primary Outcome Measures

1. Change in Pain intensity [Pain intensity is assessed daily from baseline to the end of treatment (resulting in 20-27 measuring time points)]

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

Secondary Outcome Measures

1. 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)]

   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)

2. 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)]

   Chronic Pain Acceptance Questionnaire (CPAQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher pain acceptance)

3. Change in engaged living [Engaged Living is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)]

   Engaged Living Scale (ELS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher engaged living)

4. Change in pain catastrophizing [Pain Catastrophizing is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)]

   Pain Catastrophizing Scale (PCS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher catastrophizing)

5. Change in psychological flexibility [Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)]

   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)

6. Change in self-efficacy [Self-efficacy is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)]

   Pain Self-efficacy Questionnaire (PSEQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher self-efficacy)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Philipps University Marburg Medical Center

Investigators

• Principal Investigator: Winfried Rief, PhD, Philipps University Marburg Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jenny Riecke, Principal Investigator Jenny Riecke, Philipps University Marburg Medical Center
• ClinicalTrials.gov Identifier: NCT05205889
• Other Study ID Numbers: SCA0222
• First Posted: Jan 25, 2022
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Feb 15, 2022