NCT07755527

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable pain

Timeline
6mo left

Started Sep 2026

Shorter than P25 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

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Opioid UsePain

Outcome Measures

Primary Outcomes (1)

  • 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).

    Post-intervention (40-day follow-up)

Secondary Outcomes (2)

  • Treatment adherence

    Post-intervention (40-day follow-up)

  • Study adherence

    Post-intervention (40-day follow-up)

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will receive a computerized brief intervention followed by four weekly psychological treatment sessions.

Behavioral: Psychological Intervention

Interventions

Psychological InterventionBEHAVIORAL

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.

Intervention

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 30 days or more prior to this hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Lisa Matero, PhD

CONTACT

313-874-5454LMatero1@hfhs.org

Study Design

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

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08