Trial Outcomes & Findings for Single Session Class to Reduce Opioid Use in Chronic Pain (NCT NCT03950791)
NCT ID: NCT03950791
Last Updated: 2024-11-26
Results Overview
Clinically minimal reduction is defined as \>15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
baseline and 3 months
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Pain Catastrophizing Class
A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.
Pain Catastrophizing Class: A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.
|
Health Education
A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.
Health Education: Education about improving lifestyle factors to improve participants' overall health.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
105
|
|
Overall Study
COMPLETED
|
81
|
88
|
|
Overall Study
NOT COMPLETED
|
27
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Session Class to Reduce Opioid Use in Chronic Pain
Baseline characteristics by cohort
| Measure |
Pain Catastrophizing Class
n=108 Participants
A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.
Pain Catastrophizing Class: A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.
|
Health Education
n=105 Participants
A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.
Health Education: Education about improving lifestyle factors to improve participants' overall health.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
86 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
202 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Opioid Use
|
133.5 MME
STANDARD_DEVIATION 197.4 • n=99 Participants
|
109.6 MME
STANDARD_DEVIATION 163.3 • n=107 Participants
|
121.7 MME
STANDARD_DEVIATION 181.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 monthsPopulation: Sample was comprised of participants who had available data at both baseline and primary endpoint assessments (3 months post-treatment).
Clinically minimal reduction is defined as \>15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)
Outcome measures
| Measure |
Pain Catastrophizing Class
n=84 Participants
A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.
Pain Catastrophizing Class: A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.
|
Health Education
n=91 Participants
A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.
Health Education: Education about improving lifestyle factors to improve participants' overall health.
|
|---|---|---|
|
Opioid Use
|
-6.7 MME
Standard Deviation 64.0
|
-8.0 MME
Standard Deviation 46.8
|
Adverse Events
Pain Catastrophizing Class
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pain Catastrophizing Class
n=108 participants at risk
A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.
Pain Catastrophizing Class: A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.
|
Health Education
n=105 participants at risk
A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.
Health Education: Education about improving lifestyle factors to improve participants' overall health.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.93%
1/108 • Number of events 1 • Adverse event data were collected at baseline, pre-class assessment, and 3-, 6-, and 12-month follow-up assessments.
|
0.00%
0/105 • Adverse event data were collected at baseline, pre-class assessment, and 3-, 6-, and 12-month follow-up assessments.
|
Other adverse events
Adverse event data not reported
Additional Information
Maisa Ziadni, PhD
Stanford University School of Medicine
Phone: (650) 724-9143
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place