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Single Session Class to Reduce Opioid Use in Chronic Pain

Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03950791
Enrollment
213
Registered
2019-05-15
Start date
2019-09-23
Completion date
2024-05-31
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Brief summary

Prescription opioids are one of the most commonly used treatments for chronic pain, despite limited evidence of their efficacy and high morbidity and mortality risks. The study aims to determine the efficacy of a targeted single-session psychology class in reducing opioid use among patients with chronic pain. The information gained from this study has the potential to identify patients who achieve a meaningful reduction in opioid use and inform opioid reduction strategies.

Detailed description

The opioid epidemic is a serious national crisis that affects public health as well as social and economic welfare, with increasing and alarming mortality rates in the United States. Consequently, there is an urgent need for effective and efficient interventions to address opioid use to prevent the risk of opioid misuse and better address it once it is established. One of the greatest predictors for increased opioid use among patients with chronic pain is pain catastrophizing (PC), defined as persistent negative cognitive and emotional responses to actual or anticipated pain. Untreated PC can lead to increased opioid use and facilitate the risk for misuse and overuse of medications, particularly when surgery and pharmacologics are the focal medical care plan. Despite critical need, there are no targeted interventions that efficiently address the key psychological factors that can amplify both pain, need for opioids, and increased risk for misuse. This project aims to address this urgent need for efficient and effective solutions. A 2-hour targeted, single-session pain catastrophizing class (PC-class) has been developed, rooted in cognitive-behavior therapy (CBT) approaches, aimed at reducing opioid use by reducing pain catastrophizing in chronic pain. This targeted, brief treatment obviates many of the existing barriers and burdens to usual comprehensive pain-CBT, such as the time required to attend 8 sessions, insurance coverage, travel costs, lack of skilled clinicians, patient attrition, and copayments. The investigators will implement a randomized controlled trial comparing the PC-class to a health education control class. Aim 1, To determine the efficacy of the PC class in reducing opioid use among patients with mixed-etiology pain conditions. Aim 2, To collect daily data that will allow the conduct of analyses on the daily experience of catastrophizing and how it relates to opioid use, as well as its dynamic response to treatment. The investigators will use this daily data to characterize the mechanistic influence of catastrophizing on opioid use both on the daily-level and prospectively. Patient outcomes will be longitudinally tracked at 1, 3, 6, and 12 months after the intervention session. This project aims to identify patients who achieve a meaningful reduction in opioid use, which will enable better characterization of treatment responders and refining opioid reduction strategies.

Interventions

BEHAVIORALPain 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.

BEHAVIORALHealth Education

Education about improving lifestyle factors to improve participants' overall health.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 18-80 years of age * Diagnosis of chronic non-cancer pain (\> 3 months in duration) * Currently using prescription opioids ≥ 10mg morphine equivalent daily dose (MEDD) for ≥ 3 months; * Ability and willingness to complete study procedures.

Exclusion criteria

* Open litigation regarding a medical condition * Inability to provide informed consent and complete study procedures * Previous experience with cognitive behavioral therapy (CBT) * Active suicidality.

Design outcomes

Primary

MeasureTime frameDescription
Opioid Usebaseline and 3 monthsClinically minimal reduction is defined as \>15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
108
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.
105
Total213

Baseline characteristics

CharacteristicPain Catastrophizing ClassHealth EducationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
19 Participants19 Participants38 Participants
Age, Categorical
Between 18 and 65 years
89 Participants86 Participants175 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants7 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
104 Participants98 Participants202 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Opioid Use133.5 MME
STANDARD_DEVIATION 197.4
109.6 MME
STANDARD_DEVIATION 163.3
121.7 MME
STANDARD_DEVIATION 181.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants6 Participants
Race (NIH/OMB)
More than one race
3 Participants6 Participants9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants
Race (NIH/OMB)
White
101 Participants90 Participants191 Participants
Sex/Gender, Customized
Female
86 Participants83 Participants169 Participants
Sex/Gender, Customized
Male
21 Participants22 Participants43 Participants
Sex/Gender, Customized
Other
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1080 / 105
other
Total, other adverse events
0 / 1080 / 105
serious
Total, serious adverse events
1 / 1080 / 105

Outcome results

Primary

Opioid Use

Clinically minimal reduction is defined as \>15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)

Time frame: baseline and 3 months

Population: Sample was comprised of participants who had available data at both baseline and primary endpoint assessments (3 months post-treatment).

ArmMeasureValue (MEAN)Dispersion
Pain Catastrophizing ClassOpioid Use-6.7 MMEStandard Deviation 64
Health EducationOpioid Use-8.0 MMEStandard Deviation 46.8
Comparison: Morphine equivalent dosage outcome variables were not normally distributed (skewness values between 4.5 and 4.8, kurtosis values between 25.7 and 30.0), which necessitated non-parametric analysis using independent-samples Mann-Whitney U Testp-value: 0.89Independent-samples Mann-Whitney U

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026