Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05205889
Other study ID # SCA0222
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT01417923 - The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain Phase 4
Completed NCT03472521 - Prevention of Persistent Opioid Use in Mothers Phase 4
Not yet recruiting NCT03249025 - Lidocaine-Ketamine for Management of Chronic Pain N/A
Recruiting NCT05877274 - Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
Completed NCT03317782 - NoL Index Variations Before and After a Stellate Ganglion Block
Completed NCT04199858 - Electrophysiological Correlates of Nocebo Effects on Pain N/A
Recruiting NCT05491499 - Assessing the Impact of Exercise Based Intensive Interdisciplinary Pain Treatment (IIPT) on Endogenous Pain Modulation in Youth With Chronic Pain Syndromes
Active, not recruiting NCT05090683 - Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain. N/A
Completed NCT04197154 - Pain-related Fear as a Facilitator of Nocebo Hyperalgesia N/A
Completed NCT04209764 - Prevalence of Pain in the Departments of Surgery and Oncoematology of a Children's Hospital
Recruiting NCT06071962 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain Phase 3
Recruiting NCT06071975 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy Phase 3
Recruiting NCT06072573 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy Phase 3
Recruiting NCT06071949 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis Phase 3
Recruiting NCT06072001 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis Phase 3
Recruiting NCT06072560 - Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain Phase 3
Recruiting NCT06071988 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy Phase 3
Recruiting NCT06071936 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative Peripheral Neuropathy Phase 3
Completed NCT03460717 - Thermal Micro-cautery for Painful Knee Osteoarthritis N/A
Recruiting NCT05678127 - A Pilot Study to Explore the Use of Skin Biopsy as Diagnostic Tool in Anterior Cutaneous Nerve Entrapment Syndrome (ACNES) N/A