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Completed

NCT Number: NCT05205889

A Mobile Intervention on Values in Chronic Pain Patients.

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.

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Key information

Conditions

Chronic Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Marburg

Marburg, Hesse, 35032, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Pain intensity

    Time frame: 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 outcomes

  1. Change in 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)

    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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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