- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07755527
Healing After Injury to Reduce Opioid Use and Pain Through Preventive Engagement - Open Trial (HOPE)
August 5, 2026 updated by: Lisa Matero, Henry Ford Health System
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Matero, PhD
- Phone Number: 313-874-5454
- Email: LMatero1@hfhs.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Admitted to Henry Ford Hospital
- Has an acute musculoskeletal injury
- Prescribed opioids during the admission
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants will receive a computerized brief intervention followed by four weekly psychological treatment sessions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Post-intervention (40-day follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment adherence
Time Frame: Post-intervention (40-day follow-up)
|
Percentage of participants that attended at least 3 of 4 sessions
|
Post-intervention (40-day follow-up)
|
|
Study adherence
Time Frame: Post-intervention (40-day follow-up)
|
Percentage of participants that completed the post-intervention assessment
|
Post-intervention (40-day follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
August 5, 2026
First Submitted That Met QC Criteria
August 5, 2026
First Posted (Actual)
August 10, 2026
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 5, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOPE-Open
- R34DA060172 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.