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Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01591564
Enrollment
3
Registered
2012-05-04
Start date
2012-07-31
Completion date
2013-12-31
Last updated
2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mood Dysregulation

Keywords

interpersonal psychotherapy, severe mood dysregulation

Brief summary

The purpose of this study is to determine the feasibility and acceptability of an utilizing an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD). The investigators hypothesize that retention rates will be \>80%,satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD intervention will have overall improvement in SMD symptoms.

Interventions

BEHAVIORALInterpersonal Psychotherapy for youth with SMD (IPT-SMD)

Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Male and female subjects, ages 13 to 17 years, who meet criteria for severe mood dysregulation as defined by NIMH criteria. * Subject has an estimated IQ \>70 on the Kaufman Brief Intelligence Test (KBIT-2) * Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form. * Participants must be on the same dose of any prescribed medication for 4 weeks prior to randomization. * Children's Global Assessment Scale (CGAS) ≤ 60

Exclusion criteria

* Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician. * Subject suffers from a concomitant medical or psychiatric co-morbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment). * Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks). * Pregnant females. * Primary caretaker does not speak English

Design outcomes

Primary

MeasureTime frameDescription
Retention rate20 weeksWe are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.

Secondary

MeasureTime frameDescription
Clinical Global Impressions Scale CGI-I (SMD)20 weeksWe will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026