Chronic PainMORE-JITAINCT04567043
Treating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
A study testing MORE+JITAI and Supporive Psychotherapy in people with Chronic Pain, run by University of Utah at 1 site in United States.
Trial summary
This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy. 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?
- MORE+JITAI and Supporive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to Sep 2023
- 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
- Current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)
- Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
- Willingness to participate in study interventions and assessments
Who cannot join
- Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
- Active suicidality, schizophrenia, psychotic disorder
- Presence of clinically unstable systemic illness judged to interfere with treatment
- No access to internet (which will prevent telehealth-based treatment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112
About this study
Official title: Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
This pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy.
- Conditions
- Chronic Pain
- Being tested
- MORE+JITAI, Supporive Psychotherapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORE+JITAIBehavioural
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse. JITAI involves stress-triggered reminders to practice mindfulness skills.
Supporive PsychotherapyBehavioural
A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement+JITAI | Experimental | Participants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks. Receives: Behavioral: MORE+JITAI |
| Supportive Psychotherapy | Active comparator | Participants will attend a telehealth supportive psychotherapy group weekly for eight weeks. Receives: Behavioral: Supporive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in momentary craving
Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving)
Measured: Baseline through 1-month follow-up
Change in momentary pain: numeric rating scale
Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain)
Measured: Baseline through 1-month follow-up
Secondary outcomes (3)
Change in momentary positive affect
Positive affect measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more positive affect)
Measured: Baseline through 1-month follow-up
Change in momentary stress
Stress measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more stress)
Measured: Baseline through 1-month follow-up
Change in heart rate variability
Changes in heart rate variability (HRV) measured via ambulatory HRV assessment
Measured: Baseline through 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start24 Sep 2020
- Primary completion4 Jan 2023
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567043
- Sponsor's protocol ID
- 00078615.2
- Acronym
- MORE-JITAI
- Status last verified
- Jul 2023
- First submitted
- 22 Sep 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garland EL, Manusov EG, Froeliger B, Kelly A, Williams JM, Howard MO. Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. J Consult Clin Psychol. 2014 Jun;82(3):448-459. doi: 10.1037/a0035798. Epub 2014 Feb 3.
PubMed 24491075Garland EL, Gullapalli BT, Prince KC, Hanley AW, Sanyer M, Tuomenoksa M, Rahman T. Zoom-Based Mindfulness-Oriented Recovery Enhancement Plus Just-in-Time Mindfulness Practice Triggered by Wearable Sensors for Opioid Craving and Chronic Pain. Mindfulness (N Y). 2023 May 24:1-17. doi: 10.1007/s12671-023-02137-0. Online ahead of print.
PubMed 37362184
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reating Opioid Misuse Via Mindfulness-Based Just-in-Time Adaptive Intervention
- ClinicalTrials.gov ID
- NCT04567043
- Acronym / sponsor ID
- MORE-JITAI / 00078615.2
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 Sep 2020 (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 pilot RCT will examine the preliminary efficacy of a telehealth version of Mindfulness-Oriented Recovery Enhancement (MORE) enriched with a smartphone-based just-in-time adaptive intervention (JITAI) for patients with chronic pain on long-term opioid therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Oriented Recovery Enhancement+JITAI | Experimental | Behavioral: MORE+JITAIParticipants will attend a telehealth Mindfulness-Oriented Recovery Enhancement (MORE) group plus mindfulness JITAI weekly for eight weeks. |
| Supportive Psychotherapy | Active comparator | Behavioral: Supporive PsychotherapyParticipants will attend a telehealth supportive psychotherapy group weekly for eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)
- Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for >90 days
- Willingness to participate in study interventions and assessments
Key exclusion criteria (4 listed)
- Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
- Active suicidality, schizophrenia, psychotic disorder
- Presence of clinically unstable systemic illness judged to interfere with treatment
- No access to internet (which will prevent telehealth-based treatment)
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 |
|---|---|---|
| MORE+JITAIMindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse. JITAI involves stress-triggered reminders to practice mindfulness skills. | Behavioural | Mindfulness-Oriented Recovery Enhancement+JITAI |
| Supporive PsychotherapyA supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist. | Behavioural | Supportive Psychotherapy |
Primary outcome
Change in momentary craving
Time frame: Baseline through 1-month follow-up
Craving measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more craving)
Change in momentary pain: numeric rating scale
Time frame: Baseline through 1-month follow-up
Pain measured by numeric rating scale via ecological momentary assessments (min 0, max 10, with higher scores meaning more pain)
3 secondary outcomes
Change in momentary positive affect
Time frame: Baseline through 1-month follow-up
Change in momentary stress
Time frame: Baseline through 1-month follow-up
Change in heart rate variability
Time frame: Baseline through 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: PubMed 24491075Garland EL, Manusov EG, Froeliger B, Kelly A, Williams JM, Howard MO. Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. J Consult Clin Psychol. 2014 Jun;82(3):448-459. doi: 10.1037/a0035798. Epub 2014 Feb 3.
- Derived from this study: PubMed 37362184Garland EL, Gullapalli BT, Prince KC, Hanley AW, Sanyer M, Tuomenoksa M, Rahman T. Zoom-Based Mindfulness-Oriented Recovery Enhancement Plus Just-in-Time Mindfulness Practice Triggered by Wearable Sensors for Opioid Craving and Chronic Pain. Mindfulness (N Y). 2023 May 24:1-17. doi: 10.1007/s12671-023-02137-0. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MORE+JITAI and Supporive Psychotherapy in people with Chronic Pain, run by University of Utah 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Jul 2023. 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?
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?
Change in momentary craving (time frame: Baseline through 1-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04567043, which also lists 2 linked publications.
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 5 Jul 2023.