PainHOPENCT07755527
Healing After Injury to Reduce Opioid Use and Pain Through Preventive Engagement - Open Trial
A study testing Psychological Intervention in people with Pain and Opioid Use, run by Henry Ford Health System.
Trial summary
The goal of this project is to refine the adaptive psychological intervention and assess initial feasibility and acceptability. Results will be used to inform a pilot randomized trial. 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?
- Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2027
- 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 project is to refine the adaptive psychological intervention and assess initial feasibility and acceptability. Results will be used to inform a pilot randomized trial.
- Conditions
- Pain, Opioid Use
- Being tested
- Psychological Intervention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological InterventionBehavioural
Participants will complete a computerized brief intervention (education about long-term opioid use and a mindfulness strategy) followed by four psychotherapy sessions composed of education, mindfulness, and acceptance-based strategies.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | Participants will receive a computerized brief intervention followed by four weekly psychological treatment sessions. Receives: Behavioral: Psychological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
Percentage of participants that agreed/strongly agreed with items on the acceptability of intervention measure (AIM), intervention appropriateness measure (IAM), and feasibility of intervention measure (FIM).
Measured: Post-intervention (40-day follow-up)
Secondary outcomes (2)
Treatment adherence
Percentage of participants that attended at least 3 of 4 sessions
Measured: Post-intervention (40-day follow-up)
Study adherence
Percentage of participants that completed the post-intervention assessment
Measured: Post-intervention (40-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 posted10 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT07755527
- Sponsor's protocol ID
- HOPE-Open
- Other IDs
- R34DA060172
- Acronym
- HOPE
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 23 Sep 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 23 Sep 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
- NCT07755527
- Acronym / sponsor ID
- HOPE / HOPE-Open
- Conditions
- Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 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 project is to refine the adaptive psychological intervention and assess initial feasibility and acceptability. Results will be used to inform a pilot randomized trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Psychological InterventionParticipants will receive a computerized brief intervention followed by four weekly 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 |
|---|---|---|
| Psychological InterventionParticipants will complete a computerized brief intervention (education about long-term opioid use and a mindfulness strategy) followed by four psychotherapy sessions composed of education, mindfulness, and acceptance-based strategies. | Behavioural | Psychological Intervention |
Primary outcome
Acceptability of the intervention
Time frame: Post-intervention (40-day follow-up)
Percentage of participants that agreed/strongly agreed with items on the acceptability of intervention measure (AIM), intervention appropriateness measure (IAM), and feasibility of intervention measure (FIM).
2 secondary outcomes
Treatment adherence
Time frame: Post-intervention (40-day follow-up)
Study adherence
Time frame: Post-intervention (40-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 23 Sep 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 Psychological Intervention 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 23 Sep 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?
Acceptability of the intervention (time frame: Post-intervention (40-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 23 Sep 2026.