- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275607
Maladaptive Anger Treatment
Cognitive Behavioral Affective Therapy (CBAT) for Maladaptive Anger in a Community Sample: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
P.I. Dr. Fernandez and Ph.D. student Brandon Perez will train about five undergraduate students in the recruitment procedures. Participants will be recruited by sending electronic announcements and IRB-approved recruitment materials to 1) counseling and psychotherapy clinics, 2) anger management support groups, and 3) social media platforms. Materials will contain study and contact information (study email address and Google Voice number) for potential participants to contact study staff. Interested participants will sign consent forms and be screened for eligibility via an electronic version of the consent form and a brief screening instrument, both presented using an online App (created on Thunkable) for administration of questionnaires. After successfully completing screening, participants will enter their phone number and email address. Participants who do not satisfy screening criteria will be notified accordingly.
Consent and Screening: Participants will first go through the informed consent procedure, where they will be told about the purpose of the study, expectations for them as participants, etc. Informed consent is expected to take approximately 10 minutes. Participants will then be asked to complete a screening questionnaire which is expected to take no more than 3 minutes. These procedures are done via the earlier-mentioned Smart Phone Application. Eligible participants will be randomly assigned to one of two groups: (i) a treatment group receiving Cognitive Behavioral Affective Therapy (CBAT), or (ii) a comparison group receiving Emotional Education (EE). Each group will receive separate links to videos (specific to the content of that group) and pre-recorded by Dr. Fernandez. There will be two videos per week, each lasting about 50 minutes (no more than 8 hours total) over the course of 4 weeks. At 1-month follow-up, each group will be required to view/listen to a final 50-minute videorecording that recaps the specific content for that group.
Questionnaires and other measures: Anger will be screened using the 10-item trait scale of the STAXI-2. At pre-treatment, post-treatment, and follow-up, anger will be assessed using two psychometric instruments, the Anger Parameters Scale and the Anger Expressions Scale. During each of these three phases, anger will also be measured via self-monitoring with reference to a graphical display. These measurement techniques have been effectively used and described in our previous studies.
Online Sessions: The video for session 1 will deal with orientation and self-monitoring. Participants will practice self-monitoring their anger during that first week of orientation. If a participant has no anger on a given day, no monitoring is necessary. Following this week, the comparison group participants will continue to self-monitor their anger for 4 weeks during which they will view/listen to videos on the general topic of emotions (including anger, fear, sadness, as well as positive emotions such as joy). CBAT participants will continue to self-monitor their anger for 4 weeks during which they will view/listen to videos on anger regulation techniques. These videos will cover anger prevention, anger intervention, and anger postvention consecutively. During the prevention phase, an individually tailored behavior contract against anger will be signed by each participant that allows them to reward themselves for adhering to anger reduction goals. Contracts such as these are commonly used in behavior modification. Not legally binding they are formal agreements made collaboratively between provider and participant. They are designed to build motivation and commitment to change. Specifically, both parties agree on the desired or adaptive behaviors, the points to be awarded for such behaviors, and the points to be deducted in the case of maladaptive behaviors. The net number of points is then regularly reviewed by both parties and any appropriate rewards are then "given." In CBAT, rewards are typically watching a favorite movie, dining out at a favorite restaurant, etc. Participants will work with investigators over email to draft and electronically sign their contracts. Research Assistants will review participant progress on their contracts during their regular check-in phone calls. While there is no feasible way to ensure total adherence to the contract - either with in-person or online CBAT training - the phone calls are useful in encouraging participation and self-monitoring. For EE, participants will receive self-monitoring training with an emphasis on the definition of emotion, and types of emotions. Instead of specific skills for regulating anger or other emotions, a range of emotions (e.g., fear, anxiety, sorrow, grief, melancholy, guilt, embarrassment, self-consciousness, pride, contempt, jealousy, surprise, and happiness) will be illustrated with sources from art, literature and the humanities in general. While the comparison group will not receive any skills training for anger regulation, emotional education will receive educational information on negative emotions (such as anger) and positive emotions too.
CBAT participants will also engage in anger prevention techniques such as behavioral rehearsal of anger-provoking situations and stimulus control for discriminating and avoiding situations that are likely to culminate in anger. Intervention techniques include use of thought-stopping, distraction, reappraisal, and replacing maladaptive cognition with coping statements. The postvention phase will train participants in dealing with residual anger through expressive writing and verbal disclosure. Gestalt therapy empty chair dialogue will be used for overcoming unresolved anger. Finally, affective strategies of humor and forgiveness will also be broached.
After the final session (in week 5), participants in both groups will complete the same set of questionnaires previously administered before treatment. This set of questionnaires is expected to take no more than 20 minutes. Participants will then have a 3-week interim waiting period, during which time no action is required on their part, but one intended to serve as a time for participants to reflect and implement techniques that they have learned. This is followed by 1 week of daily anger self-monitoring. Finally, a follow-up session (30-50 minutes) will be held with both groups after this self-monitoring period.
Phone Calls and Knowledge Checks: To ensure that participants comprehend the online videos, RAs will check in with participants twice a week. This also serves to ensure that there are no difficulties with their participation in the study and to verify that the participants are not in any emotional distress. Each semi-weekly phone calls is expected to last approximately 10 minutes, for a total time of 160 minutes over the duration of the study (1 week pre-treatment, 4 weeks of CBAT or EE; and 1 week post-treatment).
Total participant time commitment during the duration of the study is approximately 12 hours.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ephrem Fernandez, Ph.D.
- Phone Number: (210) 458-5755
- Email: ephrem.fernandez@utsa.edu
Study Contact Backup
- Name: Brandon S Perez, M.S.
- Phone Number: (281) 975-9534
- Email: brandon.perez3@utsa.edu
Study Locations
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Texas
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San Antonio, Texas, United States, 78249
- Recruiting
- The University of Texas at San Antonio
-
Contact:
- Ephrem Fernandez, Ph.D.
- Email: ephrem.fernandez@utsa.edu
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Contact:
- Brandon S Perez, M.S.
- Email: brandon.perez3@utsa.edu
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Principal Investigator:
- Ephrem Fernandez, Ph.D.
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Sub-Investigator:
- Brandon S Perez, M.S.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Live in the United States
- Have maladaptive anger (as assessed by the STAXI-2)
- Do not currently have any serious psychiatric illnesses (e.g., schizophrenia, autism, dementia, suicidal ideation)
- Are not currently undergoing psychological or psychiatric treatment
- Are not currently undergoing an anger treatment program
- Speak English
Exclusion Criteria:
- Does not live in the United States
- Does not have maladaptive anger, as assessed by the STAXI-2
- Has a current serious psychiatric illness (e.g., schizophrenia, autism, dementia, suicidal ideation)
- Is currently undergoing psychological or psychiatric treatment
- Is currently undergoing an anger treatment program
- Does not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioral Affective Therapy
Group receiving CBAT.
|
Active training in regulating anger.
|
Placebo Comparator: Emotional Education
Group receiving general emotion psychoeducation.
|
General discussion of emotions; no therapy or training is offered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anger Parameters Scale (APS)
Time Frame: Baseline
|
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold. 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. |
Baseline
|
Anger Parameters Scale (APS)
Time Frame: One-month
|
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold. 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
|
Anger Parameters Scale (APS)
Time Frame: One month after end of treatment program
|
The Anger Parameters Scale taps into five parameters: Frequency, Duration, Intensity, Latency, and Threshold. 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 after end of treatment program
|
Anger Expressions Scale (AES)
Time Frame: Baseline
|
Measured with the Anger Expressions Scale.
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.
|
Baseline
|
Anger Expressions Scale (AES)
Time Frame: One-month
|
Measured with the Anger Expressions Scale.
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
|
Anger Expressions Scale (AES)
Time Frame: One month after end of treatment program
|
Measured with the Anger Expressions Scale.
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 treatment program
|
Self-Monitored Anger (Anger Log)
Time Frame: Baseline up to 4 weeks
|
Self-monitoring has been successfully implemented for the assessment of anger .
The anger log comprises two graphs that range from 12:00 AM to 12:00 PM and 12:00 PM to 12:00 AM, covering a 24-hour period.
More specifically, the x-axis represents the time of day, and the y-axis represents the severity of anger.
The scale ranges in severity and is broken down into levels: anger, annoyance, and rage.
|
Baseline up to 4 weeks
|
Self-Monitored Anger (Anger Log)
Time Frame: One week after the interim period
|
Self-monitoring has been successfully implemented for the assessment of anger .
The anger log comprises two graphs that range from 12:00 AM to 12:00 PM and 12:00 PM to 12:00 AM, covering a 24-hour period.
More specifically, the x-axis represents the time of day, and the y-axis represents the severity of anger.
The scale ranges in severity and is broken down into levels: anger, annoyance, and rage.
|
One week after the interim period
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Fernandez, E. (2008). The angry personality: A representation on six dimensions of anger expression. https://doi.org/10.4135/9781849200479
- Fernandez, E., Arevalo, I., Torralba A., & Vargas, R. (2014). Norms for Five Parameters of Anger: How Do Incarcerated Adults Differ From the Community?. International Journal of Forensic Mental Health. 13. 18-24. https://doi.org/10.1080/14999013.2014.889256
- Fernandez, E. & Beck, R. (2001). Cognitive-Behavioral Self-Intervention Versus SelfMonitoring of Anger: Effects on Anger Frequency, Duration, and Intensity. Behavioural and Cognitive Psychotherapy, 29(3). 345-356. http://doi.org/10.1017/S1352465801003071
- Fernandez E, Pham TM, Kolaparthi K, Sun R, Perez BS, Iwuala EC, Wu W, Shattuck EC. Parameters of anger as related to sensory-affective components of pain. Scand J Pain. 2022 Dec 9;23(2):284-290. doi: 10.1515/sjpain-2022-0131. Print 2023 Apr 25.
- Fernandez E, Perez B, Sun R, Kolaparthi K, Pham T, Iwuala E, Garza R, Shattuck EC, Wu W. Anger treatment via CBAT delivered remotely: Outcomes on psychometric and self-monitored measures of anger. Clin Psychol Psychother. 2023 Sep 12. doi: 10.1002/cpp.2907. Online ahead of print.
- Fernandez E, Scott S. Anger treatment in chemically-dependent inpatients: evaluation of phase effects and gender. Behav Cogn Psychother. 2009 Jul;37(4):431-47. doi: 10.1017/S1352465809990075. Epub 2009 Jun 23.
- Fernandez E, Woldgabreal Y, Guharajan D, Day A, Kiageri V, Ramtahal N. Social Desirability Bias Against Admitting Anger: Bias in the Test-Taker or Bias in the Test? J Pers Assess. 2019 Nov-Dec;101(6):644-652. doi: 10.1080/00223891.2018.1464017. Epub 2018 May 9.
- Henderson, M. M. (2016). The anger parameters scale and the anger expressions scale: A psychometric study. The University of Texas at San Antonio.
- Spielberger, C. D., Sydeman, S. J., Owen, A. E., & Marsh, B. J. (1999). Measuring anxiety and anger with the State-Trait Anxiety Inventory (STAI) and the State-Trait Anger Expression Inventory (STAXI). In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (2nd ed., pp. 993-1021). Lawrence Erlbaum Associates Publishers.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FY23-24-93
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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