NCT07741201

Brief 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 development of chronic pain and long-term opioid use.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
20mo left

Started Oct 2026

Typical duration for not_applicable pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

PainOpioid Use

Outcome Measures

Primary Outcomes (1)

  • Opioid use

    Whether patient was using opioids

    90-day follow-up

Secondary Outcomes (11)

  • Morphine Dose Equivalent (MDE)

    90-day follow-up

  • Presence of chronic pain

    90-day follow-up

  • Pain severity

    90-day follow-up

  • Pain interference

    90-day follow-up

  • Mindfulness

    90-day follow-up

  • +6 more secondary outcomes

Study Arms (5)

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.

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.

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.

Behavioral: Computerized brief interventionBehavioral: 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.

Behavioral: Computerized brief interventionBehavioral: Psychological sessionsBehavioral: Opioid taper recommendations

Interventions

Computerized brief interventionBEHAVIORAL

Education about long-term opioid use and a mindfulness strategy

Subgroup 3Subgroup 4Subgroup 5
Opioid taper recommendationsBEHAVIORAL

Recommendations will be provided to taper opioid use.

Subgroup 2Subgroup 4Subgroup 5
Psychological sessionsBEHAVIORAL

Four sessions composed of education, mindfulness, and acceptance-based strategies.

Subgroup 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to Henry Ford Hospital
  • Has an acute musculoskeletal injury
  • Prescribed opioids during the admission

You may not qualify if:

  • 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 within the 30 days prior to this hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa Matero, PhD

CONTACT

313-874-5454LMatero1@hfhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 3, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

August 3, 2026

Record last verified: 2026-07