Back PainJOOLNCT03667040
E-health Resilience Program For Chronic Spine Pain
A study testing JOOL app in people with Back Pain and Neck Pain, run by University of Michigan at 1 site in United States.
Trial summary
This study will examine a e-health resilience based program, JOOL, for chronic spine pain patients through the following aims: Aim 1: To test the effectiveness of a resilience based program known as JOOL Aim 2: To evaluate the characteristics of the participants most likely to benefit from this treatment Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- JOOL app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2018to 15 Mar 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of the UM Back \& Pain Center
- Primary diagnosis of neck or back pain (spine pain)
- Age 18-70
- English speaking
- Able to provide consent
- Willing to download the mobile application and comply with study procedures
- Antidepressant medications stable for ≥ 4 weeks
- No plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g. back surgery, physical therapy, behavioral therapy
Who cannot join
- Having known psychotic disorder or the presence of another psychiatric condition (e.g. severe depression [HADS scores ≥ 15], suicidal ideation) or cognitive impairment (e.g. severe dyslexia, TBI) limiting ability to give consent and/or participate fully in the study
- Currently undergoing psychotherapeutic care at the Back \& Pain Center because many of the concepts that are the focus of this study are already employed in that treatment
- Other factors that at the discretion of the investigators would adversely affect study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Back & Pain Center, University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: A Randomized Controlled Trial of an E-health Resilience Program For Chronic Spine Pain
This study will examine a e-health resilience based program, JOOL, for chronic spine pain patients through the following aims:
Aim 1: To test the effectiveness of a resilience based program known as JOOL Aim 2: To evaluate the characteristics of the participants most likely to benefit from this treatment
Read the detailed description
This is a pilot RCT in which 150 patients with chronic spine pain will be randomized to one of two arms: (1) a group that downloads the JOOL mobile application resilience program; and (2) a control group.The primary outcome will be a change in physical function.
- Being tested
- JOOL app
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOOL appBehavioural
Participants will use the JOOL app for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 75 participants will take part in three visits (baseline, 30days and 60days) |
| Intervention | Active comparator | 75 participants will take complete a baseline visit and then participate in the intervention. They will use the application, the JOOL app for 30 days. Then complete surveys at 30days and 60days after the interventions Receives: Behavioral: JOOL app |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10
10 item survey measuring physical function. Each question is measured on a scale of 1-5. The lowest score being 10 and highest score is 50. A higher score correlates with poor physical functioning.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start9 Aug 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 150 participants will be recruited; 75 participants into the intervention group and 75 into the control group. There will three visits, baseline and follow-up at 30 days and 60 days.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afton Hassett, Psy.D., University of Michigan
- Investigators
- Afton Hassett, PsyD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667040
- Sponsor's protocol ID
- HUM00146178
- Acronym
- JOOL
- Status last verified
- Jul 2019
- First submitted
- 7 Sep 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an E-health Resilience Program For Chronic Spine Pain
- ClinicalTrials.gov ID
- NCT03667040
- Acronym / sponsor ID
- JOOL / HUM00146178
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 12 Sep 2018 (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.
This study will examine a e-health resilience based program, JOOL, for chronic spine pain patients through the following aims:
Aim 1: To test the effectiveness of a resilience based program known as JOOL Aim 2: To evaluate the characteristics of the participants most likely to benefit from this treatment
Detailed description
This is a pilot RCT in which 150 patients with chronic spine pain will be randomized to one of two arms: (1) a group that downloads the JOOL mobile application resilience program; and (2) a control group.The primary outcome will be a change in physical function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 150 participants will be recruited; 75 participants into the intervention group and 75 into the control group. There will three visits, baseline and follow-up at 30 days and 60 days.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –75 participants will take part in three visits (baseline, 30days and 60days) |
| Intervention | Active comparator | Behavioral: JOOL app75 participants will take complete a baseline visit and then participate in the intervention. They will use the application, the JOOL app for 30 days. Then complete surveys at 30days and 60days after the interventions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient of the UM Back \& Pain Center
- Primary diagnosis of neck or back pain (spine pain)
- Age 18-70
- English speaking
- Able to provide consent
Key exclusion criteria (3 listed)
- Having known psychotic disorder or the presence of another psychiatric condition (e.g. severe depression [HADS scores ≥ 15], suicidal ideation) or cognitive impairment (e.g. severe dyslexia, TBI) limiting ability to give consent and/or participate fully in the study
- Currently undergoing psychotherapeutic care at the Back \& Pain Center because many of the concepts that are the focus of this study are already employed in that treatment
- Other factors that at the discretion of the investigators would adversely affect study participation.
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 |
|---|---|---|
| JOOL appParticipants will use the JOOL app for 30 days | Behavioural | Intervention |
Primary outcome
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10
Time frame: 2 month
10 item survey measuring physical function. Each question is measured on a scale of 1-5. The lowest score being 10 and highest score is 50. A higher score correlates with poor physical functioning.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Afton Hassett, PsyD 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 JOOL app in people with Back Pain and Neck 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 8 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: stopped early, as of the sponsor's last update on 7 Aug 2019. 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?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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?
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10 (time frame: 2 month). 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 Aug 2019.