Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00127400
Other study ID # 11487A
Secondary ID
Status Completed
Phase Phase 2
First received August 3, 2005
Last updated September 4, 2013
Start date February 2002
Est. completion date July 2006

Study information

Verified date September 2013
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see how different forms of "Anger Management" compare in reducing anger and impulsive aggressive symptoms in people. "Anger Management" is a common form of "talk therapy" used to help people with anger problems. There are different types of "talk therapy" used to help people for anger problems and this study will compare two types of talk therapy in people with Intermittent Explosive Disorder (IED). IED is a disorder in which there are frequent and sudden outbursts of anger (yelling, throwing and breaking things, hitting people) that lead to problems with other people socially or at work.


Description:

Intermittent Explosive Disorder (IED) is increasingly acknowledged as a common, potentially disabling psychiatric condition. Despite this, there are currently no empirically supported behavioral treatments for patients with IED. The purpose of the proposed study is to assess the short-term and long-term efficacy of a cognitive-behavioral treatment (CBT), previously found to be successful in treating dysfunctional anger, for treating IED. Secondary goals of the project are to:

1. explore mechanisms involved in the successful treatment of IED, and

2. examine individual differences associated with treatment response.

Seventy-two subjects meeting for both research and DSM IED criteria will be randomly assigned to either 12 weeks of individual CBT, 12 weeks of group CBT or 12 weeks of a wait-list control condition. Subjects will be assessed before and after therapy/wait-list as well as at 3 month and 6 month follow-up. Primary outcome measures will assess aggressive behavior, anger, and the presence of an IED diagnosis at post-treatment, 6-month follow-up and 12-month follow-up. Social and emotional information processing will be evaluated as potential mechanism of change. Trait aggression will be assessed as a potential moderating variable.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- The subject meets research criteria for a lifetime diagnosis of intermittent explosive disorder (IED).

- The subject has a Trait Anger Score > 21 on the STAXI (see above).

- Subject is willing to be randomized to any one of the four conditions.

- The subject is willing and able to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.)

- Subject gives informed consent to participate in study.

Exclusion Criteria:

- The subject has any history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I bipolar mood disorder, schizophrenia, delusional disorder, organic brain disorder, mental retardation.

- The subject meets DSM-IV criteria for alcohol or drug dependence within 30 days prior to the start of any of the study conditions.

- The subject has a Beck Depression Inventory, 2nd Edition (BDI-II) score > 32.

- The subject has aggressive obsessions in the context of Obsessive Compulsive Disorder (OCD).

- Current suicidal behavior or homicidal ideation.

- The subject is not willing to be randomized to any one of the four conditions.

- The subject is not willing to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.).

- The subject, in the opinion of the principal investigator (PI), is not able or likely to cooperate with study protocol (i.e., keep appointments, complete rating forms, etc.)

- The subject is already engaged in an anger management program elsewhere.

- The subject does not give informed consent to participate in study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
anger management therapy


Locations

Country Name City State
United States The University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (9)

Deffenbacher JL, Oetting ER, Lynch RS, Morris CD. The expression of anger and its consequences. Behav Res Ther. 1996 Jul;34(7):575-90. — View Citation

Deffenbacher, J. L., & McKay, M. (2000). Overcoming Situational and General Anger: A protocol for the treatment of anger based on relaxation, cognitive restructuring, and coping skills training. New Harbinger Publication: Oakland

Deffenbacher, J. L., & Stark, R. S. (1992). Relaxation and cognitive-relaxation treatments of general anger. Journal of Counseling Psychology, 39, 158-167.

Deffenbacher, J. L., Filetti, L. B., Lynch, R. S., Dahlen, E.R., & Oetting, E. R. (2002). Cognitive-behavioral treatment of high anger. Behavioral Research Therapy, 34, 575-590.

Deffenbacher, J. L., McNamara, K., Stark, R. S., & Sabadell, P. M. (1990a). A comparison of cognitive-behavioral and process-oriented group counseling for general anger reduction. Journal of Counseling & Development, 69, 167-69.

Deffenbacher, J. L., McNamara, K., Stark, R. S., & Sabadell, P. M. (1990b). A combination of cognitive, relaxation, and behavioral coping skills in the reduction of general anger. Journal of College Student Development, 31, 351-358.

Deffenbacher, J. L., Oetting, E. R., Huff, M. E., & Thwaites, G. A. (1995). Fifteen-month follow-up of social skills and cognitive-relaxation approaches to general anger reduction. Journal of Counseling Psychology, 42, 400-405.

Deffenbacher, J. L., Oetting, E. R., Huff, M. E., Cornell, G. R., & Dallager, C. J. (1996a). Evaluation of two cognitive-behavioral approaches to general anger reduction. Cognitive Therapy and Research, 20, 551-573.

DiGiuseppe, R. & Tafrate, R. C. (2003). Anger Treatment for Adults: A Meta-Analytic Review. Clinical Psychology Science & Practice, 10, 70-84.

Outcome

Type Measure Description Time frame Safety issue
Primary Aggression interview (Overt Aggression Scale-Modified
Primary [OASM]) at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
Primary State-Trait Anxiety Inventory (STAXI) questionnaire at midpoint 1 week post-treatment, 3-month follow-up and 6-month follow-up
Secondary Behavioral aggression measures (Taylor Aggression Paradigm [TAP], Point Subtraction Aggression Paradigm [PSAP]) at 1 week post-treatment
See also
  Status Clinical Trial Phase
Completed NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Completed NCT01093053 - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations N/A
Terminated NCT00624520 - Mental Stress Reduction in Defibrillator Patients Phase 3
Completed NCT03697837 - Digital Parent Training for Disruptive Behaviors in Children N/A
Completed NCT03683979 - The Impact of Interpretation Bias Modification Training on Anger and Reactive Aggression N/A
Terminated NCT04192448 - Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression N/A
Completed NCT04776304 - Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms N/A
Completed NCT01918696 - Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention N/A
Completed NCT00197951 - Clinical Trial With Ziprasidone for the Treatment of Psychiatric Pathology Associated to Alcoholism Phase 3
Recruiting NCT04702711 - Experiences of Anger in Patients in Primary Health Care With Symptoms of Generalized Anxiety
Completed NCT03693209 - Using Implementation Intentions to Reduce Anger and Aggression in Adolescence N/A
Not yet recruiting NCT06094933 - Randomized Clinical Trial of MARI N/A
Recruiting NCT06242717 - Postpartum Screening for Anxiety and Comorbid Conditions
Completed NCT02954146 - Mobile Health Application for Family and Behavioral Health Provider Communication N/A
Completed NCT01965184 - Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents N/A
Completed NCT04620122 - Effects of Progressive Muscle Relaxation Training With Music Therapy on Sleep Quality and Trait Anger/Anger Expression Style of Patients at Community Mental Health Center N/A
Completed NCT03907995 - Peer-led Group Intervention for Coping With Disaster N/A
Recruiting NCT00866411 - Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms N/A
Enrolling by invitation NCT06308601 - The Effect of Laughter Yoga on Loneliness, Anger and Salivary Cortisol Levels in Visually Impaired Individuals N/A
Completed NCT04174040 - Process Model of Emotion Regulation Integrated Musical Rhythm Interventions' Effects on Student Nurses' Anger N/A