Chronic Pain, Opioids, and Anger Treatment

NCT04438746 | Unknown

• 1 other identifier: #20-002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Anger; Opioid Use; Chronic Pain

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change in chronic pain ratings at one month

  Single item measured on a scale from 0-10

  One month

• 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

• 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

• 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

Study Arms (2)

Group receiving CBAT

EXPERIMENTAL

Behavioral: Cognitive Behavioral Affective Therapy

Group receiving general emotion training

PLACEBO COMPARATOR

Behavioral: Emotion discussion

Interventions

Emotion discussion BEHAVIORAL

General discussion of emotions; no therapy or training is offered

Group receiving general emotion training

Cognitive Behavioral Affective Therapy BEHAVIORAL

Active training in regulating anger

Group receiving CBAT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas at San Antonio: lead

Study Sites (1)

University of Texas at San Antonio

San Antonio, Texas, 78249, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ephrem Fernandez, PhD

  University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychology

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 19, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

US (1)