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Not yet recruiting NCT07741201

Healing After Injury to Reduce Opioid Use and Pain Through Preventive Engagement

No phase Interventional Pain Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computerized brief intervention, Psychological sessions, Opioid taper recommendations.
Who it may be relevant to
Registry conditions: Pain, Opioid Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Adaptive Psychological Intervention to Improve Pain and Reduce Opioid Use Following an Injury

Overview

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.

Interventions

  • Behavioral Computerized brief intervention
    Education about long-term opioid use and a mindfulness strategy
  • Behavioral Psychological sessions
    Four sessions composed of education, mindfulness, and acceptance-based strategies.
  • Behavioral Opioid taper recommendations
    Recommendations will be provided to taper opioid use.

Primary outcome measures

  • Opioid use [Time frame: 90-day follow-up]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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 within the 30 days prior to this hospitalization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07741201 · HOPE · R34DA060172

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗