Chronic Pain Clinical Trial
Official title:
Alleviating Pain and Opioid Dependence Through Anger Management: A Pilot Study
Verified date | May 2022 |
Source | The University of Texas at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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..
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: - |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas at San Antonio |
United States,
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 |
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