Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01591564|
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : March 31, 2015
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.
|Condition or disease||Intervention/treatment|
|Severe Mood Dysregulation||Behavioral: Interpersonal Psychotherapy for youth with SMD (IPT-SMD)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot|
|Study Start Date :||July 2012|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
All participants will receive the intervention.
Behavioral: Interpersonal 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.
- Retention rate [ Time Frame: 20 weeks ]We are assessing the feasibility and acceptability of IPT-SMD in anticipation of conducting a larger trial.
- Clinical Global Impressions Scale CGI-I (SMD) [ Time Frame: 20 weeks ]We will utilize the CGI-I (SMD) to assess the effectiveness of IPT-SMD on the severity of SMD symptoms in youth with SMD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591564
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Leslie Miller, M.D.||Johns Hopkins University|