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Protocol Details

Psychological Treatments for Youth with Severe Irritability

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 8 Years
Max Age: 17 Years

Referral Letter Required


Population Exclusion(s)



Interpretation Bias Training;
Cognitive Behavioral Therapy;
Natural History

Recruitment Keyword(s)




Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Mental Health


When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.


To test two whether IBT and CBT can decrease severe irritability in children and youth.


Children 8-17 years old with DMDD. Their symptoms must have started before age 10.


Participants will be screened with a review of their symptoms. Parents and participants will answer questions.

Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.

Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.

Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.

Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.

Participants will do practice activities at home.

Participants doing IBT will have up to 14 sessions over 10 weeks.

Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.

Participants and parents answer questions about their progress.

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Inclusion criteria for both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:

1. Age 8-17 years

2. Must be enrolled into NIMH DIRP protocol 02-M-0021, Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in children and youth.

3. Must meet DSM 5 diagnostic criteria for DMDD which are (for CBT, must meet lifetime history of either DMDD or one of two core DMDD criteria [b or c]):

- Must meet all of the following:

a. Diagnosis must first be made between ages 6-18 years

b. Abnormal mood (specifically, anger and/or irritability), present at least half of the day most days, and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers).

c. Compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. Such events occur, on average, at least three times a week.

- The symptoms in b and c above are currently present and have been present for at least 12 months without any symptom-free periods exceeding two months.

- The onset of symptoms must be prior to age 10 years.

- The symptoms are severe in at least one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers). In addition, there are at least mild symptoms (verbal aggression) in a second setting.

4. Patients must be fluent in English

a. All instruments have not been validated in other languages.

b. Psychotherapy will be designed and conducted in English.

5. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more).

6. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment and throughout the three weeks of training and post-training assessment.


Exclusion criteria both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:

1. The individual exhibits any of these cardinal bipolar symptoms:

a. Elevated or expansive mood.

b. Grandiosity or inflated self-esteem.

c. Decreased need for sleep.

d. Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences).

e. A history of hypomanic or manic symptoms that occurred in distinct episodes lasting more than 1 day.

2. Meets DSM 5 criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or posttraumatic stress disorder.

3. IQ<70

4. The symptoms are due to the direct physiologic effects of a drug of abuse, or to a general medical or neurological condition.

5. Meets criteria for alcohol or substance abuse three months prior to enrollment.

6. Meets DSM 5 criteria for current major depressive disorder. The rationale for the exclusion of youth with MDD is because the two novel interventions being tested are contraindicated for those with major depressive disorder. However, there is no contraindication to participation for those with treated/resolved or remitted major depressive disorder; only those with a current diagnosis need to be excluded.

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Leibenluft E. Severe mood dysregulation, irritability, and the diagnostic boundaries of bipolar disorder in youths. Am J Psychiatry. 2011 Feb;168(2):129-42. doi: 10.1176/appi.ajp.2010.10050766. Epub 2010 Dec 1.

Leibenluft E, Stoddard J. The developmental psychopathology of irritability. Dev Psychopathol. 2013 Nov;25(4 Pt 2):1473-87. doi: 10.1017/S0954579413000722.

Brotman MA, Kircanski K, Stringaris A, Pine DS, Leibenluft E. Irritability in Youths: A Translational Model. Am J Psychiatry. 2017 Jun 1;174(6):520-532. doi: 10.1176/appi.ajp.2016.16070839. Epub 2017 Jan 20.

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Principal Investigator

Referral Contact

For more information:

Melissa A. Brotman, Ph.D.
National Institute of Mental Health (NIMH)
(301) 435-6645

Melissa A. Brotman, Ph.D.
National Institute of Mental Health (NIMH)
(301) 435-6645

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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