Chronic Pain SyndromeNCT05205889
A Mobile Intervention on Values in Chronic Pain Patients.
A study testing Mobile intervention on values and goals in patients with chronic pain. in people with Chronic Pain Syndrome, run by Philipps University Marburg at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- Mobile intervention on values and goals in patients with chronic pain.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, non-tumor related back pain (pain for at least 6 months)
- Ownership of a smartphone
- Numeric Rating Scale for pain result of ≥ 4
Who cannot join
- High cognitive impairment (e.g., intellectual disability)
- Currently in psychotherapeutic treatment
- Initiation of pain-focused treatment during the study
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Mobile intervention on values and goals in patients with chronic pain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile intervention on values and goals in patients with chronic pain.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile based values intervention for people with chronic pain | Experimental | Not described Receives: Behavioral: Mobile intervention on values and goals in patients with chronic pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
Numerical Pain Rating Scale (NPRS) Minimum value: 0; Maximum value: 10 (higher scores indicate higher pain intensity)
Measured: 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
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)
Measured: 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 Questionnaire (CPAQ) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher pain acceptance)
Measured: 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 Scale (ELS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher engaged living)
Measured: 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 Scale (PCS) Minimum value: 0; Maximum value: 10 (range is adapted for the study; higher scores indicate higher catastrophizing)
Measured: Pain Catastrophizing is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
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)
Measured: Psychological Flexibility is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
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)
Measured: Self-efficacy is assessed daily from baseline to the end of the study (resulting in 20-27 measuring time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start15 Feb 2022
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Riecke, Philipps University Marburg
- Investigators
- Winfried Rief, PhD, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205889
- Sponsor's protocol ID
- SCA0222
- Status last verified
- Oct 2022
- First submitted
- 21 Dec 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Intervention on Values in Chronic Pain Patients.
- ClinicalTrials.gov ID
- NCT05205889
- Acronym / sponsor ID
- SCA0222
- Conditions
- Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case analysis with 10-17 pre-measurement time points; 10 measurement time points during the intervention; and one post-measurement.
| Arm | Type | Receives |
|---|---|---|
| Mobile based values intervention for people with chronic pain | Experimental | Behavioral: Mobile intervention on values and goals in patients with chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic, non-tumor related back pain (pain for at least 6 months)
- Ownership of a smartphone
- Numeric Rating Scale for pain result of ≥ 4
Key exclusion criteria (3 listed)
- High cognitive impairment (e.g., intellectual disability)
- Currently in psychotherapeutic treatment
- Initiation of pain-focused treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mobile based values intervention for people with chronic pain |
Primary outcome
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)
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: Undecided. Data can be shared upon request.
Related trials for Chronic Pain Syndrome
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, PhD principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile intervention on values and goals in patients with chronic pain. in people with Chronic Pain Syndrome, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.