NCT00245193

Brief Summary

This study will investigate the effectiveness of motivationally-enhanced brief interpersonal psychotherapy (MI-IPT-B) in treating depression in mothers who bring their children to a child mental health clinic for psychiatric treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

First QC Date

October 25, 2005

Last Update Submit

June 21, 2013

Conditions

Keywords

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Score on the Hamilton Rating Scale for Depression; measured at baseline, Week 14, and Month 6

Secondary Outcomes (1)

  • Score on the Beck Depression Inventory; measured at baseline, Week 14, and Month 6

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biological or adoptive mother whose child between the ages of 6 and 18 is treated in the Services for Teens at Risk (STAR) Center or the Center for Children and Families (CCF)
  • Mother lives with and has custody of the child receiving treatment
  • Meets DSM-IV criteria for current unipolar depressive disorder (e.g., dysthymic disorder, depressive disorder, or single or recurrent episodes of major depressive disorder)
  • Score of greater than 16 on the Beck Depression Inventory
  • Score of greater than 15 on the Hamilton Rating Scale for Depression (17-item)
  • Willingness to maintain existing stable dose of antidepressant medication throughout the study if currently on medication and still experiencing symptoms of depression
  • Willingness of child (treated in STAR clinic or CCF) to give informed consent

You may not qualify if:

  • Currently receiving antidepressant medication at sub-therapeutic doses or at therapeutic doses but for an inadequate period of time to assess response
  • Current dose of medication has not been stable for at least 8 weeks prior to study enrollment
  • Suicidal or homicidal
  • Requires hospitalization
  • At risk for child abuse or neglect and requires intervention
  • Simultaneous psychotic disorder or organic mental disorder
  • History of drug or alcohol abuse within 6 months of study enrollment
  • History of a prior manic episode
  • Significant medical illness that might explain depressive symptoms (e.g., epilepsy, autoimmune disorders, liver dysfunction, unstable endocrine disease)
  • Not fluent in English
  • Severe cognitive deficits that would interfere with psychotherapy treatment
  • Currently receiving another form of individual psychotherapy or couples therapy (except for participation in a support group, such as Alcoholics Anonymous)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15231, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Holly Swartz, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

April 1, 2003

Study Completion

March 1, 2006

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations