An Adaptive Psychological Intervention to Improve Pain and Reduce Opioid Use Following an Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Henry Ford Health System
- Enrollment
- 80
- Primary Endpoint
- Opioid use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Subgroup 3
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.
Intervention: Computerized brief intervention (Behavioral)
Subgroup 4
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.
Intervention: Computerized brief intervention (Behavioral)
Subgroup 4
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.
Intervention: Opioid taper recommendations (Behavioral)
Subgroup 1
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
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.
Intervention: Opioid taper recommendations (Behavioral)
Subgroup 5
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.
Intervention: Computerized brief intervention (Behavioral)
Subgroup 5
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.
Intervention: Psychological sessions (Behavioral)
Subgroup 5
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.
Intervention: Opioid taper recommendations (Behavioral)
Outcomes
Primary Outcomes
Opioid use
Time Frame: 90-day follow-up
Whether patient was using opioids
Secondary Outcomes
- 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)
- Pain acceptance(90-day follow-up)
- Depression(90-day follow-up)
- Anxiety(90-day follow-up)
- Sleep(90-day follow-up)
- Impact of Events Scale Revised(90-day follow-up)
- Opioid misuse(90-day follow-up)
Investigators
Lisa Matero
Associate Scientist
Henry Ford Health System