Opioid Use, Pain
Conditions
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.
Interventions
BEHAVIORALComputerized brief intervention
Education about long-term opioid use and a mindfulness strategy
BEHAVIORALPsychological sessions
Four sessions composed of education, mindfulness, and acceptance-based strategies.
BEHAVIORALOpioid taper recommendations
Recommendations will be provided to taper opioid use.
Sponsors
Henry Ford Health System
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This project utilizes a Sequential Multiple Assignment Randomized Trial (SMART)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use | 90-day follow-up | Whether patient was using opioids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Dose Equivalent (MDE) | 90-day follow-up | Dose of opioid use in MDEs |
| Presence of chronic pain | 90-day follow-up | Whether a patient reports experiencing pain from the injury |
| Pain severity | 90-day follow-up | On a 0 (no pain) to 10 (worst pain) scale, patients rate their current pain and average, least, and worst pain over the previous week. |
| Pain interference | 90-day follow-up | Participants report on a 0 (does not interfere) to 10 (completely interferes) scale how much the pain interferes across a variety of daily activities. |
| Mindfulness | 90-day follow-up | The Mindful Attention Awareness Scale (MAAS) is a validated, 15 item measure that questions how often a patient engages in mindfulness experiences on a 1 (almost always) to 6 (almost never) point scale; scores are summed to produce a total score. Scores can range from 15-90 with higher scores indicating greater mindfulness. |
| Pain acceptance | 90-day follow-up | The Chronic Pain Acceptance Questionnaire (CPAQ) is 20 items with two validated subscales: Activities Engagement and Pain Willingness. A total score is achieved by summing these two subscales. Items are on a 0 (Never True) to 6 (Always True) Likert Scale. Scores range from 0 to 120 with higher scores indicating greater acceptance. |
| Depression | 90-day follow-up | The Patient Health Questionnaire (PHQ-9) is a 9-item measure that assesses severity of depressive symptoms. Scores range from 0 to 27 with higher scores indicating greater severity of symptoms. |
| Anxiety | 90-day follow-up | The Generalized Anxiety Disorder (GAD-7) assesses severity of anxiety symptoms. Scores range from 0 to 21 with higher scores indicating greater severity of symptoms. |
| Sleep | 90-day follow-up | The Insomnia Severity Index (ISI) measures sleep difficulty. The ISI has 7-items on a 0 to 4. Scores range from 0 to 28 with higher scores indicating greater severity of sleep problems. |
| Impact of Events Scale Revised | 90-day follow-up | This 22-item measure asks participants to respond to their level of distress regarding a specified event on a 0 to 4 scale over the past 7 days. Scores range from 0 to 88 with higher scores indicating higher distress. |
| Opioid misuse | 90-day follow-up | The Current Opioid Misuse Measure (COMM) is a 17-item measure that asks participants about behaviors associated with opioid misuse on a 0 to 4 scale. Scores range from 0 to 68. Scores of 9 or greater are considered positive for opioid misuse. |
Contacts
CONTACTLisa Matero, PhD
Outcome results
None listed