Chronic PainNCT05847881
Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.
A study testing Self-guided at home activities in people with Chronic Pain, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-guided at home activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Persistent or recurrent pain lasting longer than 3 months
- Able to read and write English
Who cannot join
- Cancer (History of any bone-related cancer or cancer that metastasized to the bone; Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months; History of any cancer treatment in the last 24 months)
- Active substance abuse
- Uncontrolled depression or psychosis
- Visual or hearing difficulties that would preclude participation
- Individuals started receiving disability or compensation within the past year, or currently involved in litigation
- Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving.
The study team hypothesizes that:
-Greater or equal to 80 percent of participants will report that the intervention was relatively easy to understand after orientation, low burden, potentially effective, and will have completed at least 2 of the 3 reflective tools.
- Conditions
- Chronic Pain
- Being tested
- Self-guided at home activities
- Keywords
- Positive psychology intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided at home activitiesBehavioural
After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
| Study group | Role | What they receive |
|---|---|---|
| Reflective process group | Experimental | Not described Receives: Behavioral: Self-guided at home activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Engaged in the Interventions
The timepoints were as follows: consent and survey (T1), Kick-off Meeting (T2), Workshop (T3), and Exit Interview (T4). Participants had to attend the Kick-off Meeting (T2) to be considered engaged in the intervention. Participants who did not attend the Kick-off Meeting (T2) were withdrawn. Participants who did not attend the Workshop (T3) could still attend the Exit Interview (T4).
Measured: Baseline (T1) to Exit Interview (T4), up to 68 days
Secondary outcomes (2)
Patient Global Impression of Change (PGIC) at T4 Exit Interview
Participants completed the PGIC at the exit interview. The PGIC had one question with seven options ranging from -3 to 3: very much worse (-3), much worse (-2), minimally worse (-1), no change (0), minimally improved (1), much improved (2), very much improved (3). A higher score indicated greater improvement since the start of the study.
Measured: at T4 Exit Interview, up to 68 days
Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview)
There were 4 questions in this questionnaire. For each question, participants selected one of five options, ranging from "not at all" (1) to "very much" (5). Total scores ranged from 4 to 20 points, where higher scores indicated more pain interference. Since this survey was discussing the change in the pain interference, a negative score indicated less pain interfering with day-to-day activities.The change betwen the baseline (T1 and Exit Interview (t4) is reported.
Measured: Up to 68 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start25 Apr 2023
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Hannah Smotrich, University of Michigan
- Investigators
- Hannah Smotrich, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847881
- Sponsor's protocol ID
- HUM00176302
- Other IDs
- UM1TR004404
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2023
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.
- ClinicalTrials.gov ID
- NCT05847881
- Acronym / sponsor ID
- HUM00176302
- Conditions
- Chronic Pain
- Keywords
- Positive psychology intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving.
The study team hypothesizes that:
-Greater or equal to 80 percent of participants will report that the intervention was relatively easy to understand after orientation, low burden, potentially effective, and will have completed at least 2 of the 3 reflective tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reflective process group | Experimental | Behavioral: Self-guided at home activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent or recurrent pain lasting longer than 3 months
- Able to read and write English
Key exclusion criteria (7 listed)
- Cancer (History of any bone-related cancer or cancer that metastasized to the bone; Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months; History of any cancer treatment in the last 24 months)
- Active substance abuse
- Uncontrolled depression or psychosis
- Visual or hearing difficulties that would preclude participation
- Individuals started receiving disability or compensation within the past year, or currently involved in litigation
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 |
|---|---|---|
| Self-guided at home activitiesAfter the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits. | Behavioural | Reflective process group |
Primary outcome
Participants Engaged in the Interventions
Time frame: Baseline (T1) to Exit Interview (T4), up to 68 days
The timepoints were as follows: consent and survey (T1), Kick-off Meeting (T2), Workshop (T3), and Exit Interview (T4). Participants had to attend the Kick-off Meeting (T2) to be considered engaged in the intervention. Participants who did not attend the Kick-off Meeting (T2) were withdrawn. Participants who did not attend the Workshop (T3) could still attend the Exit Interview (T4).
2 secondary outcomes
Patient Global Impression of Change (PGIC) at T4 Exit Interview
Time frame: at T4 Exit Interview, up to 68 days
Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview)
Time frame: Up to 68 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hannah Smotrich principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided at home activities in people with Chronic Pain, run by University of Michigan at 1 site in United States.
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 2 inclusion and 7 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 23 Oct 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants Engaged in the Interventions (time frame: Baseline (T1) to Exit Interview (T4), up to 68 days). 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 23 Oct 2024.