AngerNCT04438746
Chronic Pain, Opioids, and Anger Treatment
A study testing Emotion discussion and Cognitive Behavioral Affective Therapy in people with Anger and Opioid Use, run by The University of Texas at San Antonio at 1 site in United States.
Trial summary
The current US opioid epidemic is a pressing public health concern. Links between opioid misuse and mortality are well-known; nearly 70% of all drug overdose deaths in 2017 were attributable to opioids. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anger, Opioid Use, Chronic Pain
- What is being tested?
- Emotion discussion and Cognitive Behavioral Affective Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- taking opioid pain relievers for at least 3 months in the past 12 months
- maladaptive levels of anger as measured by STAXI-2
- without psychiatric co-morbidity (e.g., major depression, substance use disorder, etc.)
- not undergoing current psychological/psychiatric treatment
- speak English.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at San Antonio
San Antonio, Texas, 78249
About this study
Official title: Alleviating Pain and Opioid Dependence Through Anger Management: A Pilot Study
The current US opioid epidemic is a pressing public health concern. Links between opioid misuse and mortality are well-known; nearly 70% of all drug overdose deaths in 2017 were attributable to opioids. Given their pain-relieving properties, opioids have been widely used in the chronic pain population who are also susceptible to misuse of these analgesics.. In chronic pain patients with anger, the pain as well as opioid use may be aggravated. For example, suppression of anger has been linked with increased pain sensitivity in experiments, while anger-hostility scores and internalized anger predict pain severity variance and pain intensity, respectively. Anger is also linked with drug use/abuse, including opioids. The goal of this research is to implement a state-of-the-art program for anger regulation in chronic pain patients., Called Cognitive Behavioral Affective Therapy (CBAT), this program is evaluated on multiple measures of anger, sensory versus affective measures of pain, and measures of opioid misuse. CBAT is expected to reduce anger, and thereby produce reduction in pain as well as shift attitudes away from opioid misuse..
Read the detailed description
Participants will be recruited by electronic announcements and IRB approved recruitment flyers in local pain clinics and pain support groups. These ads and flyers will contain relevant info (e.g., study email address and GoogleVoice number) for prospective participants to contact study staff with any questions about participation. Interested participants will be screened by an RA on the phone using the following steps: 1) RA will obtain verbal consent upon explaining study participation and answering any questions participants may have; 2) Once informed consent is obtained, RA will use participants preferred email address to send potential participant a link to the Qualtrics screening questionnaire; 3) RA will then briefly orient participant to Qualtrics; and 3) RA will complete the screening process with participant on the phone to determine and inform participant of their eligibility to participate.
Consent and Screening: Participants will first go through the informed consent procedure, where they will be told about the purpose of the study, expectations of them as participants, etc. Informed consent is expected to take no more than 5 minutes. They will then be asked to complete a screening questionnaire which is expected to take no more than 3 minutes. Eligible participants will be randomly assigned to one of two groups: 1) Control and 2) CBAT. Both control group and experimental group participants will be required to complete 2 pre-recorded sessions per week lasting 1 hour each (total of 8 hours) over the course of 4 weeks.
Online Sessions and Surveys: After questionnaires (including measures of pain and opioid use, the Anger Parameters Scale) have been administered at pre-treatment, the first session will serve as orientation to self-monitoring anger levels between sessions. If a participant has no anger on a given day, no monitoring is necessary. Following this, control group participants self-monitor their anger and watch pre-recorded sessions on emotions in general. The treatment group will be actively trained in anger regulation skills within the framework of CBAT. These participants will proceed from a week of anger prevention to a week of intervention to a week of postvention. During the prevention phase, an individually-tailored behavior contract against anger will be signed by each paParticipants will work with investigators over email to draft and electronically sign their contracts. RAs will review participant progress toward fulfillment of contracts during weekly check-in phone calls to participants. Participants will also engage in behavioral rehearsal of anger-provoking situations and learn about stimulus control for discriminating and avoiding situations that are likely to culminate in anger.
In the Intervention phase, participants will be introduced to techniques for regulating anger that could not be prevented. These include thought-stopping, distraction, and cognitive reappraisal..
In the postvention phase, participants will be trained in techniques for ameliorating residual anger. These include expressive writing and verbal disclosure. Gestalt therapy empty chair dialogue will be used for overcoming unresolved anger.
At the conclusion of the 4 weeks of anger self-regulation training, the same questionnaires relating to anger, pain, and opioid misuse and beliefs will be assessed in both groups. This post-treatment set of questionnaires is expected to take no more than 20 minutes.
Finally, a follow-up session (2 hours) will be held for both groups one month after post-treatment. Anger, pain, and opioid use measures will be re-administered (taking no more than 20 minutes). All participants will receive a brief booster session to reinforce effective anger regulation techniques. The same pre- and post-treatment questionnaires mentioned above will be re-administered at this point in the study.
Phone Calls and Knowledge Tests: To ensure that participants are paying attention to the online videos, RAs will contact them weekly and administer a brief, multiple choice knowledge test over the phone. Participants who score less than 50% in any given week will be dropped from the study. During that same phone call, RAs will check in with participants to ensure that there are no problems with their participation in the study and that the participants are not in any emotional distress. Phone calls are anticipated to last approximately 10 minutes, for a total time of 50 minutes over the span of the study (4 weeks of either treatment or control and the 1-month follow up). Total participant time commitment over the course of the study is approximately 12 hours.
- Conditions
- Anger, Opioid Use, Chronic Pain
- Being tested
- Emotion discussion, Cognitive Behavioral Affective Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion discussionBehavioural
General discussion of emotions; no therapy or training is offered
Cognitive Behavioral Affective TherapyBehavioural
Active training in regulating anger
| Study group | Role | What they receive |
|---|---|---|
| Group receiving CBAT | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Affective Therapy |
| Group receiving general emotion training | Placebo comparator | Not described Receives: Behavioral: Emotion discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain medication dosage and frequency of use at one month
Participants are asked what pain medication they are using and at what dosage and frequency. Open-ended question.
Measured: One month
Change in pain medication dosage and frequency of use at one month follow-up
Participants are asked what pain medication they are using and at what dosage and frequency. Open-ended question.
Measured: One month after end of intervention
Change in attitudes/beliefs surrounding pain medication at one month
Assessed using the Pain Medication Beliefs Questionnaire (Schieffer et al., 2005), a five-item instrument measuring beliefs about one's response to, relief from, and potential addiction to pain medication
Measured: One month
Change in attitudes/beliefs surrounding pain medication at one month follow-up
Assessed using the Pain Medication Beliefs Questionnaire (Schieffer et al., 2005), a five-item instrument measuring beliefs about one's response to, relief from, and potential addiction to pain medication
Measured: One month after end of intervention
Change in opioid misuse at one month
Measured with the Current Opioid Misuse Measure (Butler et al., 2007), a 17-item instrument assessing signs and symptoms of drug misuse, emotional/psychiatric problems due to misuse, evidence of lying about drug use, and other domains
Measured: One month
Change in opioid misuse at one month follow-up
Measured with the Current Opioid Misuse Measure (Butler et al., 2007), a 17-item instrument assessing signs and symptoms of drug misuse, emotional/psychiatric problems due to misuse, evidence of lying about drug use, and other domains
Measured: One month after end of intervention
Change in anger parameters at one month
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold (Fernandez et al., 2014). Scores can range from 0-120 and higher scores imply more maladaptive anger.
The APS is comprised of 30 items rated from 0-4. The total possible score ranges from 0 to 120. A higher score on the APS indicates more maladaptive anger.
Measured: One month
Change in anger parameters at one month follow-up
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold (Fernandez et al., 2014). Scores can range from 0-120 and higher scores imply more maladaptive anger.
Measured: One month after end of intervention
Change in anger expression style at one month
Measured with the Anger Expression Scale (Fernandez, 2008). The AES is comprised of 60 items rated from 0-4. These items are organized into 12 sub-scales of 5 items each. These sub-scales have a minimum total possible score of 0 and a maximum of 20. Higher scores on each sub-scale (as well as a higher cumulative score) indicates more maladaptive anger.
Measured: One month
Change in anger expression style at one month follow-up
Measured with the Anger Expression Scale (Fernandez, 2008). The AES is comprised of 60 items rated from 0-4. These items are organized into 12 sub-scales of 5 items each. These sub-scales have a minimum total possible score of 0 and a maximum of 20. Higher scores on each sub-scale (as well as a higher cumulative score) indicates more maladaptive anger.
Measured: One month after end of intervention
Change in chronic pain ratings at one month
Single item measured on a scale from 0-10
Measured: One month
Change in chronic pain ratings at one month follow up
Single item measured on a scale from 0-10
Measured: One month after end of intervention
Change in emotional response to chronic pain at one month
Single item measured on a scale from "a little unpleasant" to "extremely distressing"
Measured: One month
Change in emotional response to chronic pain at one month follow-up
Single item measured on a scale from "a little unpleasant" to "extremely distressing"
Measured: One month after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ephrem Fernandez, The University of Texas at San Antonio
- Investigators
- Ephrem Fernandez, PhD, Principal investigator, University of Texas at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438746
- Sponsor's protocol ID
- #20-002
- Status last verified
- May 2022
- First submitted
- 28 May 2020
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Pain and Opioid Dependence Through Anger Management: A Pilot Study
- ClinicalTrials.gov ID
- NCT04438746
- Acronym / sponsor ID
- #20-002
- Conditions
- Anger, Opioid Use, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The University of Texas at San AntonioUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current US opioid epidemic is a pressing public health concern. Links between opioid misuse and mortality are well-known; nearly 70% of all drug overdose deaths in 2017 were attributable to opioids. Given their pain-relieving properties, opioids have been widely used in the chronic pain population who are also susceptible to misuse of these analgesics.. In chronic pain patients with anger, the pain as well as opioid use may be aggravated. For example, suppression of anger has been linked with increased pain sensitivity in experiments, while anger-hostility scores and internalized anger predict pain severity variance and pain intensity, respectively. Anger is also linked with drug use/abuse, including opioids. The goal of this research is to implement a state-of-the-art program for anger regulation in chronic pain patients., Called Cognitive Behavioral Affective Therapy (CBAT), this program is evaluated on multiple measures of anger, sensory versus affective measures of pain, and measures of opioid misuse. CBAT is expected to reduce anger, and thereby produce reduction in pain as well as shift attitudes away from opioid misuse..
Detailed description
Participants will be recruited by electronic announcements and IRB approved recruitment flyers in local pain clinics and pain support groups. These ads and flyers will contain relevant info (e.g., study email address and GoogleVoice number) for prospective participants to contact study staff with any questions about participation. Interested participants will be screened by an RA on the phone using the following steps: 1) RA will obtain verbal consent upon explaining study participation and answering any questions participants may have; 2) Once informed consent is obtained, RA will use participants preferred email address to send potential participant a link to the Qualtrics screening questionnaire; 3) RA will then briefly orient participant to Qualtrics; and 3) RA will complete the screening process with participant on the phone to determine and inform participant of their eligibility to participate.
Consent and Screening: Participants will first go through the informed consent procedure, where they will be told about the purpose of the study, expectations of them as participants, etc. Informed consent is expected to take no more than 5 minutes. They will then be asked to complete a screening questionnaire which is expected to take no more than 3 minutes. Eligible participants will be randomly assigned to one of two groups: 1) Control and 2) CBAT. Both control group and experimental group participants will be required to complete 2 pre-recorded sessions per week lasting 1 hour each (total of 8 hours) over the course of 4 weeks.
Online Sessions and Surveys: After questionnaires (including measures of pain and opioid use, the Anger Parameters Scale) have been administered at pre-treatment, the first session will serve as orientation to self-monitoring anger levels between sessions. If a participant has no anger on a given day, no monitoring is necessary. Following this, control group participants self-monitor their anger and watch pre-recorded sessions on emotions in general. The treatment group will be actively trained in anger regulation skills within the framework of CBAT. These participants will proceed from a week of anger prevention to a week of intervention to a week of postvention. During the prevention phase, an individually-tailored behavior contract against anger will be signed by each paParticipants will work with investigators over email to draft and electronically sign their contracts. RAs will review participant progress toward fulfillment of contracts during weekly check-in phone calls to participants. Participants will also engage in behavioral rehearsal of anger-provoking situations and learn about stimulus control for discriminating and avoiding situations that are likely to culminate in anger.
In the Intervention phase, participants will be introduced to techniques for regulating anger that could not be prevented. These include thought-stopping, distraction, and cognitive reappraisal..
In the postvention phase, participants will be trained in techniques for ameliorating residual anger. These include expressive writing and verbal disclosure. Gestalt therapy empty chair dialogue will be used for overcoming unresolved anger.
At the conclusion of the 4 weeks of anger self-regulation training, the same questionnaires relating to anger, pain, and opioid misuse and beliefs will be assessed in both groups. This post-treatment set of questionnaires is expected to take no more than 20 minutes.
Finally, a follow-up session (2 hours) will be held for both groups one month after post-treatment. Anger, pain, and opioid use measures will be re-administered (taking no more than 20 minutes). All participants will receive a brief booster session to reinforce effective anger regulation techniques. The same pre- and post-treatment questionnaires mentioned above will be re-administered at this point in the study.
Phone Calls and Knowledge Tests: To ensure that participants are paying attention to the online videos, RAs will contact them weekly and administer a brief, multiple choice knowledge test over the phone. Participants who score less than 50% in any given week will be dropped from the study. During that same phone call, RAs will check in with participants to ensure that there are no problems with their participation in the study and that the participants are not in any emotional distress. Phone calls are anticipated to last approximately 10 minutes, for a total time of 50 minutes over the span of the study (4 weeks of either treatment or control and the 1-month follow up). Total participant time commitment over the course of the study is approximately 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving CBAT | Experimental | Behavioral: Cognitive Behavioral Affective Therapy |
| Group receiving general emotion training | Placebo comparator | Behavioral: Emotion discussion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- taking opioid pain relievers for at least 3 months in the past 12 months
- maladaptive levels of anger as measured by STAXI-2
- without psychiatric co-morbidity (e.g., major depression, substance use disorder, etc.)
- not undergoing current psychological/psychiatric treatment
- speak English.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Emotion discussionGeneral discussion of emotions; no therapy or training is offered | Behavioural | Group receiving general emotion training |
| Cognitive Behavioral Affective TherapyActive training in regulating anger | Behavioural | Group receiving CBAT |
Primary outcome
Change in pain medication dosage and frequency of use at one month
Time frame: One month
Participants are asked what pain medication they are using and at what dosage and frequency. Open-ended question.
Change in pain medication dosage and frequency of use at one month follow-up
Time frame: One month after end of intervention
Participants are asked what pain medication they are using and at what dosage and frequency. Open-ended question.
Change in attitudes/beliefs surrounding pain medication at one month
Time frame: One month
Assessed using the Pain Medication Beliefs Questionnaire (Schieffer et al., 2005), a five-item instrument measuring beliefs about one's response to, relief from, and potential addiction to pain medication
Change in attitudes/beliefs surrounding pain medication at one month follow-up
Time frame: One month after end of intervention
Assessed using the Pain Medication Beliefs Questionnaire (Schieffer et al., 2005), a five-item instrument measuring beliefs about one's response to, relief from, and potential addiction to pain medication
Change in opioid misuse at one month
Time frame: One month
Measured with the Current Opioid Misuse Measure (Butler et al., 2007), a 17-item instrument assessing signs and symptoms of drug misuse, emotional/psychiatric problems due to misuse, evidence of lying about drug use, and other domains
Change in opioid misuse at one month follow-up
Time frame: One month after end of intervention
Measured with the Current Opioid Misuse Measure (Butler et al., 2007), a 17-item instrument assessing signs and symptoms of drug misuse, emotional/psychiatric problems due to misuse, evidence of lying about drug use, and other domains
Change in anger parameters at one month
Time frame: One month
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold (Fernandez et al., 2014). Scores can range from 0-120 and higher scores imply more maladaptive anger. The APS is comprised of 30 items rated from 0-4. The total possible score ranges from 0 to 120. A higher score on the APS indicates more maladaptive anger.
Change in anger parameters at one month follow-up
Time frame: One month after end of intervention
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold (Fernandez et al., 2014). Scores can range from 0-120 and higher scores imply more maladaptive anger.
Change in anger expression style at one month
Time frame: One month
Measured with the Anger Expression Scale (Fernandez, 2008). The AES is comprised of 60 items rated from 0-4. These items are organized into 12 sub-scales of 5 items each. These sub-scales have a minimum total possible score of 0 and a maximum of 20. Higher scores on each sub-scale (as well as a higher cumulative score) indicates more maladaptive anger.
Change in anger expression style at one month follow-up
Time frame: One month after end of intervention
Measured with the Anger Expression Scale (Fernandez, 2008). The AES is comprised of 60 items rated from 0-4. These items are organized into 12 sub-scales of 5 items each. These sub-scales have a minimum total possible score of 0 and a maximum of 20. Higher scores on each sub-scale (as well as a higher cumulative score) indicates more maladaptive anger.
Change in chronic pain ratings at one month
Time frame: One month
Single item measured on a scale from 0-10
Change in chronic pain ratings at one month follow up
Time frame: One month after end of intervention
Single item measured on a scale from 0-10
Change in emotional response to chronic pain at one month
Time frame: One month
Single item measured on a scale from "a little unpleasant" to "extremely distressing"
Change in emotional response to chronic pain at one month follow-up
Time frame: One month after end of intervention
Single item measured on a scale from "a little unpleasant" to "extremely distressing"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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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.
Ephrem Fernandez, PhD principal investigator
University of Texas at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion discussion and Cognitive Behavioral Affective Therapy in people with Anger and Opioid Use, run by The University of Texas at San Antonio 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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?
Results are not available in the source record.
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?
Change in pain medication dosage and frequency of use at one month (time frame: One month). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2022.