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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH090246 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to determine the feasibility and acceptability of utilizing an adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood dysregulation disorder (DMDD).
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 intervention will have overall improvement in SMD/DMDD symptoms.
This research is being done to learn more about how to help teenagers with a sad or angry mood, and emotional responses out of proportion to what would be expected in a situation. Together these symptoms are called Severe Mood Dysregulation (SMD), a research diagnosis, or disruptive mood dysregulation disorder (DMDD), a newer clinical diagnosis. Currently, there is no standard treatment for teens that have SMD/DMDD. These teens usually receive medication and some type of talk therapy. This research is being done to compare two types of talk therapy to see which is most effective in helping teens with SMD/DMDD. Investigators will compare treatment as usual (TAU) with Interpersonal Psychotherapy for Youth with Mood and Behavior Dysregulation (IPT-MBD). Investigators do not know if TAU and IPT-MBD work just as well, or if one is better than the other. When this study is over, investigators hope there will be a better idea of how to study treatments for teens with SMD/DMDD.
For those participants who receive IPT-MBD, are prescribed an antipsychotic, and have significant improvement in symptoms, investigators will gradually taper the antipsychotic dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual (TAU) | Active Comparator | Participants who are not randomly assigned to the IPT-MBD group will continue with treatment at usual, which is considered routine care. |
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| IPT-MBD | Other | Weekly Interpersonal Therapy for SMD/DMDD (IPT-MBD) sessions, which emphasizes building skills in managing relationships, helping with problem solving, strengthening communication skills and other skills. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPT-MBD | Other | IPT-MBD is a modified form of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), which emphasizes building skills in managing relationships, helping with problem solving, and strengthening communication skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention rate | To describe/assess feasibility of IPT-MBD, investigators will look at ease of recruitment and retention rate goal of at least 80%. Investigators will collect data on the number of subjects recruited, enrolled, and who followed the protocol for 24 weeks. Investigators will comment on adherence to the overall study, as well as to specific treatment visits. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Scale for SMD/DMDD (CGI-SMD/DMDD) | Investigators will utilize the Clinical Global Impressions Scale for Global Improvement (CGI-I) and Severity of Illness (CGI-S) to measure improvement in SMD/DMDD symptoms and to assess the effectiveness of IPT-MBD on the severity of SMD/DMDD symptoms in youth with SMD/DMDD. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Miller, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C024274 | adenylate isopentenyltransferase |
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| Satisfaction | To assess the feasibility and acceptability of a 24-week psychosocial treatment intervention for youth with SMD/DMDD, investigators will compare satisfaction questionnaires between treatment arms. | 24 weeks |