Chronic Pain, Opioids, and Anger Treatment

Chronic Pain Clinical Trial

Official title:

Alleviating Pain and Opioid Dependence Through Anger Management: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04438746
• Other study ID #: #20-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2022
• Source: The University of Texas at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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..

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anger
• Chronic Pain
• Opioid Use

Intervention

Behavioral:
• Emotion discussion
General discussion of emotions; no therapy or training is offered
• Cognitive Behavioral Affective Therapy
Active training in regulating anger

Locations

Country	Name	City	State
United States	University of Texas at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One month
Primary	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.	One month after end of intervention
Primary	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	One month
Primary	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	One month after end of intervention
Primary	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	One month
Primary	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	One month after end of intervention
Primary	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.	One month
Primary	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.	One month after end of intervention
Primary	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.	One month
Primary	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.	One month after end of intervention
Primary	Change in chronic pain ratings at one month	Single item measured on a scale from 0-10	One month
Primary	Change in chronic pain ratings at one month follow up	Single item measured on a scale from 0-10	One month after end of intervention
Primary	Change in emotional response to chronic pain at one month	Single item measured on a scale from "a little unpleasant" to "extremely distressing"	One month
Primary	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"	One month after end of intervention