"Empowered Relief: On-Demand" for People With Prescription Opioid Misuse and Chronic Pain
Study Details
Study Description
Brief Summary
The investigators will implement a 2-arm online pragmatic feasibility randomized controlled trial (RCT) of E-ROD (final digital intervention name is pending but will be referred to here as E-ROD - "Empowered Relief: On-Demand") to reduce pain-specific distress, opioid craving, and opioid misuse. They will compare E-ROD to an interactive digital health education (HE) intervention in community-based individuals with comorbid chronic pain and opioid misuse (N=220). Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, immediately post-treatment; at post-treatment weeks 1 and 2; and months 1, 2, and 3.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Most people who misuse prescription opioids report doing so for pain relief. This study will investigate a digital intervention for people with comorbid chronic pain and opioid misuse.
The intervention, tentatively entitled "Empowered Relief: On-Demand" (E-ROD), will include roughly 60 minutes of interactive digital pain education and pain management skills content with multimedia features. The investigators will conduct a fully online RCT of E-ROD in a national sample of people with comorbid chronic pain and opioid misuse.
The investigators will implement a 2-arm online feasibility RCT of E-ROD to reduce pain-specific distress, opioid craving, and opioid misuse. They will compare E-ROD to an interactive digital health education (HE) intervention in community-based individuals with comorbid chronic pain and opioid misuse (N=220). Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, immediately post-treatment; at post-treatment weeks 1 and 2; and months 1, 2, and 3.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E-ROD Empowered Relief: On-Demand (E-ROD) will include roughly 60 minutes of interactive and multimedia pain educational content that targets pain and stress self-regulation, pain medication misuse, a personalized plan for relief and a 'relaxation medicine' app. |
Behavioral: E-ROD
Tailored digital health treatment
|
| Placebo Comparator: Health Education (HE) The HE arm is an interactive digital general health education intervention that is devoid of specific content on pain, psychological skills, and has no active strategies or worksheets. |
Behavioral: Health Education
General HE digital intervention devoid of pain education, psychological skills, and has no active strategies or worksheets.
|
Outcome Measures
Primary Outcome Measures
- Pain intensity [baseline]
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable"
- Pain intensity [post-treatment week 1]
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable"
- Pain intensity [post-treatment week 2]
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable"
- Pain intensity [post-treatment month 1 (Primary Endpoint)]
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable"
- Pain intensity [post-treatment month 2]
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable"
- Pain intensity [post-treatment month 3]
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable"
- Pain catastrophizing [baseline]
4 items demonstrating internal consistency and construct validity
- Pain catastrophizing [immediately post-treatment]
4 items demonstrating internal consistency and construct validity
- Pain catastrophizing [post-treatment week 1]
4 items demonstrating internal consistency and construct validity
- Pain catastrophizing [post-treatment week 2]
4 items demonstrating internal consistency and construct validity
- Pain catastrophizing [post-treatment month 1 (Primary Endpoint)]
4 items demonstrating internal consistency and construct validity
- Pain catastrophizing [post-treatment month 2]
4 items demonstrating internal consistency and construct validity
- Pain catastrophizing [post-treatment months 3]
4 items demonstrating internal consistency and construct validity
- Pain interference [baseline]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Pain interference [immediately post-treatment]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Pain interference [post-treatment week 1]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Pain interference [post-treatment week 2]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Pain interference [post-treatment month 1 (Primary Endpoint)]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Pain interference [post-treatment month 2]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Pain interference [post-treatment month 3]
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
- Current prescription opioid misuse [baseline]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Current prescription opioid misuse [immediately post-treatment]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Current prescription opioid misuse [post-treatment week 1]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Current prescription opioid misuse [post-treatment week 2]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Current prescription opioid misuse [post-treatment month 1 (Primary Endpoint)]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Current prescription opioid misuse [post-treatment month 2]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Current prescription opioid misuse [post-treatment month 3 (Secondary Endpoint)]
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four item response scale (0 = "never" to 4 = "very often").
- Opioid craving [baseline]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid craving [immediately post-treatment]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid craving [post-treatment week 1]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid craving [post-treatment week 2]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid craving [post-treatment month 1 (Primary Endpoint)]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid craving [post-treatment month 2]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid craving [post-treatment months 3 (Secondary Endpoint)]
"Please indicate how much opioid craving you have experienced over the past week?" (0 = "no craving" to 10 = "strongest craving ever")
- Opioid prescription [baseline]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Opioid prescription [immediately post-treatment]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Opioid prescription [post-treatment week 1]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Opioid prescription [post-treatment week 2]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Opioid prescription [post-treatment month 1]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Opioid prescription [post-treatment month 2]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Opioid prescription [post-treatment months 3]
Self-report data are confirmed telephonically at baseline, and post-treatment months 1 and 3
- Treatment engagement [Immediately post-treatment (Primary Outcome)]
Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment
- Treatment appraisal [Immediately post-treatment (Primary Outcome)]
3 items assess satisfaction and perceived utility of assigned treatment (7-point scale where 0 = "not at all satisfied" to 6 = "extremely satisfied")
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and females 18 years of age or older
-
Chronic non-cancer pain (at least 6 months in duration)
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Daily prescription opioid use (at least 10 morphine milliequivalent daily dose; MEDD) for at least 3 months
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Opioid misuse (at least 9 on the Current Opioid Misuse Measure; COMM)
-
English fluency
-
Email access
Exclusion Criteria:
-
Gross cognitive impairment
-
Current medicolegal factors (open disability claim)
-
Inability to complete study electronic surveys
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 61643