PainHOPENCT07741201
Healing After Injury to Reduce Opioid Use and Pain Through Preventive Engagement
A study testing Computerized brief intervention, Psychological sessions and Opioid taper recommendations in people with Pain and Opioid Use, run by Henry Ford Health System.
Trial summary
The goal of this proposed project is to optimize the adaptive psychological intervention and assess the feasibility and acceptability. The long-term objective of this line of research is to evaluate whether an adaptive psychological intervention delivered after a musculoskeletal injury is effective in preventing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Opioid Use
- What is being tested?
- Computerized brief intervention, Psychological sessions and Opioid taper recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Admitted to Henry Ford Hospital
- Has an acute musculoskeletal injury
- Prescribed opioids during the admission
Who cannot join
- Under age 18
- Cognitive impairment (i.e., diagnosis of delirium, dementia, or traumatic brain injury/Glasgow Coma Scale less than 13)
- Chronic pain condition (i.e., pain most of the day, nearly every day for the past 3 months or longer)
- Taking opioids 30 days or more prior to this hospitalization
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Adaptive Psychological Intervention to Improve Pain and Reduce Opioid Use Following an Injury
The goal of this proposed project is to optimize the adaptive psychological intervention and assess the feasibility and acceptability. The long-term objective of this line of research is to evaluate whether an adaptive psychological intervention delivered after a musculoskeletal injury is effective in preventing the development of chronic pain and long-term opioid use.
- Conditions
- Pain, Opioid Use
- Being tested
- Computerized brief intervention, Psychological sessions, Opioid taper recommendations
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized brief interventionBehavioural
Education about long-term opioid use and a mindfulness strategy
Psychological sessionsBehavioural
Four sessions composed of education, mindfulness, and acceptance-based strategies.
Opioid taper recommendationsBehavioural
Recommendations will be provided to taper opioid use.
| Study group | Role | What they receive |
|---|---|---|
| Subgroup 1 | No intervention | Participants who were not randomized to the computerized brief intervention and were no longer on opioids 10 days post-baseline and did not receive any further treatment. |
| Subgroup 2 | Active comparator | Participants who were not randomized to the computerized brief intervention but were on opioids 10 days post-baseline and received recommendations for an opioid taper. Receives: Behavioral: Opioid taper recommendations |
| Subgroup 3 | Experimental | Participants who were randomized to the computerized brief intervention but were no longer on opioids 10 days post-baseline and did not receive any further treatment. Receives: Behavioral: Computerized brief intervention |
| Subgroup 4 | Experimental | Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper. Receives: Behavioral: Computerized brief intervention; Behavioral: Opioid taper recommendations |
| Subgroup 5 | Experimental | Participants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper plus additional psychological treatment sessions. Receives: Behavioral: Computerized brief intervention; Behavioral: Psychological sessions; Behavioral: Opioid taper recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
Whether patient was using opioids
Measured: 90-day follow-up
Secondary outcomes (11)
Morphine Dose Equivalent (MDE)
Dose of opioid use in MDEs
Measured: 90-day follow-up
Presence of chronic pain
Whether a patient reports experiencing pain from the injury
Measured: 90-day follow-up
Pain severity
On a 0 (no pain) to 10 (worst pain) scale, patients rate their current pain and average, least, and worst pain over the previous week.
Measured: 90-day follow-up
Pain interference
Participants report on a 0 (does not interfere) to 10 (completely interferes) scale how much the pain interferes across a variety of daily activities.
Measured: 90-day follow-up
Mindfulness
The Mindful Attention Awareness Scale (MAAS) is a validated, 15 item measure that questions how often a patient engages in mindfulness experiences on a 1 (almost always) to 6 (almost never) point scale; scores are summed to produce a total score. Scores can range from 15-90 with higher scores indicating greater mindfulness.
Measured: 90-day follow-up
Pain acceptance
The Chronic Pain Acceptance Questionnaire (CPAQ) is 20 items with two validated subscales: Activities Engagement and Pain Willingness. A total score is achieved by summing these two subscales. Items are on a 0 (Never True) to 6 (Always True) Likert Scale. Scores range from 0 to 120 with higher scores indicating greater acceptance.
Measured: 90-day follow-up
Depression
The Patient Health Questionnaire (PHQ-9) is a 9-item measure that assesses severity of depressive symptoms. Scores range from 0 to 27 with higher scores indicating greater severity of symptoms.
Measured: 90-day follow-up
Anxiety
The Generalized Anxiety Disorder (GAD-7) assesses severity of anxiety symptoms. Scores range from 0 to 21 with higher scores indicating greater severity of symptoms.
Measured: 90-day follow-up
Sleep
The Insomnia Severity Index (ISI) measures sleep difficulty. The ISI has 7-items on a 0 to 4. Scores range from 0 to 28 with higher scores indicating greater severity of sleep problems.
Measured: 90-day follow-up
Impact of Events Scale Revised
This 22-item measure asks participants to respond to their level of distress regarding a specified event on a 0 to 4 scale over the past 7 days. Scores range from 0 to 88 with higher scores indicating higher distress.
Measured: 90-day follow-up
Opioid misuse
The Current Opioid Misuse Measure (COMM) is a 17-item measure that asks participants about behaviors associated with opioid misuse on a 0 to 4 scale. Scores range from 0 to 68. Scores of 9 or greater are considered positive for opioid misuse.
Measured: 90-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Mar 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This project utilizes a Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisa Matero, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741201
- Sponsor's protocol ID
- HOPE
- Other IDs
- R34DA060172
- Acronym
- HOPE
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Psychological Intervention to Improve Pain and Reduce Opioid Use Following an Injury
- ClinicalTrials.gov ID
- NCT07741201
- Acronym / sponsor ID
- HOPE / HOPE
- Conditions
- Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 3 Aug 2026 (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 goal of this proposed project is to optimize the adaptive psychological intervention and assess the feasibility and acceptability. The long-term objective of this line of research is to evaluate whether an adaptive psychological intervention delivered after a musculoskeletal injury is effective in preventing the development of chronic pain and long-term opioid use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This project utilizes a Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Subgroup 1 | No intervention | –Participants who were not randomized to the computerized brief intervention and were no longer on opioids 10 days post-baseline and did not receive any further treatment. |
| Subgroup 2 | Active comparator | Behavioral: Opioid taper recommendationsParticipants who were not randomized to the computerized brief intervention but were on opioids 10 days post-baseline and received recommendations for an opioid taper. |
| Subgroup 3 | Experimental | Behavioral: Computerized brief interventionParticipants who were randomized to the computerized brief intervention but were no longer on opioids 10 days post-baseline and did not receive any further treatment. |
| Subgroup 4 | Experimental | Behavioral: Computerized brief intervention, Behavioral: Opioid taper recommendationsParticipants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper. |
| Subgroup 5 | Experimental | Behavioral: Computerized brief intervention, Behavioral: Psychological sessions, Behavioral: Opioid taper recommendationsParticipants who were randomized to the computerized brief intervention and were still on opioids 10 days post-baseline and were then randomized to receive the recommendations for the opioid taper plus additional psychological treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to Henry Ford Hospital
- Has an acute musculoskeletal injury
- Prescribed opioids during the admission
Key exclusion criteria (4 listed)
- Under age 18
- Cognitive impairment (i.e., diagnosis of delirium, dementia, or traumatic brain injury/Glasgow Coma Scale less than 13)
- Chronic pain condition (i.e., pain most of the day, nearly every day for the past 3 months or longer)
- Taking opioids 30 days or more prior to this hospitalization
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 |
|---|---|---|
| Computerized brief interventionEducation about long-term opioid use and a mindfulness strategy | Behavioural | Subgroup 3, Subgroup 4, Subgroup 5 |
| Psychological sessionsFour sessions composed of education, mindfulness, and acceptance-based strategies. | Behavioural | Subgroup 5 |
| Opioid taper recommendationsRecommendations will be provided to taper opioid use. | Behavioural | Subgroup 2, Subgroup 4, Subgroup 5 |
Primary outcome
Opioid use
Time frame: 90-day follow-up
Whether patient was using opioids
11 secondary outcomes
Morphine Dose Equivalent (MDE)
Time frame: 90-day follow-up
Presence of chronic pain
Time frame: 90-day follow-up
Pain severity
Time frame: 90-day follow-up
Pain interference
Time frame: 90-day follow-up
Mindfulness
Time frame: 90-day follow-up
Pain acceptance
Time frame: 90-day follow-up
Depression
Time frame: 90-day follow-up
Anxiety
Time frame: 90-day follow-up
Sleep
Time frame: 90-day follow-up
Impact of Events Scale Revised
Time frame: 90-day follow-up
Opioid misuse
Time frame: 90-day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized brief intervention, Psychological sessions and Opioid taper recommendations in people with Pain and Opioid Use, run by Henry Ford Health System.
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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Matero, PhD (313-874-5454, LMatero1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use (time frame: 90-day follow-up). 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 10 Aug 2026.