Chronic PainNCT03950791
Single Session Class to Reduce Opioid Use in Chronic Pain
A study testing Pain Catastrophizing Class and Health Education in people with Chronic Pain, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain Catastrophizing Class and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Open litigation regarding a medical condition
- Inability to provide informed consent and complete study procedures
- Previous experience with cognitive behavioral therapy (CBT)
- Active suicidality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Pain Catastrophizing Class, Health Education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Catastrophizing ClassBehavioural
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 EducationBehavioural
Education about improving lifestyle factors to improve participants' overall health.
| Study group | Role | What they receive |
|---|---|---|
| Pain Catastrophizing Class | Experimental | 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. Receives: Behavioral: Pain Catastrophizing Class |
| Health Education | Placebo comparator | A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start23 Sep 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Maisa Ziadni, Stanford University
- Investigators
- Maisa Ziadni, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950791
- Sponsor's protocol ID
- 48784
- Other IDs
- K23DA047473
- Status last verified
- Nov 2024
- First submitted
- 10 May 2019
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziadni MS, Herrick A, Sturgeon JA, Salmasi V, Darnall BD, Mackey S. Single-session, virtual, pain relief skills class for adults with chronic pain on long-term opioids: A randomized controlled trial. J Pain. 2026 Jul;44:106286. doi: 10.1016/j.jpain.2026.106286. Epub 2026 Apr 15.
PubMed 41990980Ziadni MS, Chen AL, Winslow T, Mackey SC, Darnall BD. Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):521. doi: 10.1186/s13063-020-04415-x.
PubMed 32532346
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03950791
- Acronym / sponsor ID
- 48784
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Catastrophizing Class | Experimental | Behavioral: Pain Catastrophizing ClassA 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. |
| Health Education | Placebo comparator | Behavioral: Health EducationA 2-hour in-person informational session about general health education. Participants receive a list of resources in the community. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Open litigation regarding a medical condition
- Inability to provide informed consent and complete study procedures
- Previous experience with cognitive behavioral therapy (CBT)
- Active suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Catastrophizing ClassA 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. | Behavioural | Pain Catastrophizing Class |
| Health EducationEducation about improving lifestyle factors to improve participants' overall health. | Behavioural | Health Education |
Primary outcome
Opioid Use
Time frame: baseline and 3 months
Clinically minimal reduction is defined as >15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41990980Ziadni MS, Herrick A, Sturgeon JA, Salmasi V, Darnall BD, Mackey S. Single-session, virtual, pain relief skills class for adults with chronic pain on long-term opioids: A randomized controlled trial. J Pain. 2026 Jul;44:106286. doi: 10.1016/j.jpain.2026.106286. Epub 2026 Apr 15.
- Derived from this study: PubMed 32532346Ziadni MS, Chen AL, Winslow T, Mackey SC, Darnall BD. Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):521. doi: 10.1186/s13063-020-04415-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maisa Ziadni, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Catastrophizing Class and Health Education in people with Chronic Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950791, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.