Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics

NCT ID: NCT00270244

Last Updated: 2011-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-01-31

Brief Summary

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This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving the treatment of depressed adolescents in school-based health clinics.

Detailed Description

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Depression is a serious medical condition. It occurs in people of all ages, but only in the past two decades has depression in children and adolescents been taken seriously. Children and adolescents with depression may exhibit such behaviors as pretending to be sick, refusing to go to school or getting in trouble at school, clinging to a parent or worrying that the parent may die, sulking, or acting in a negative or grouchy manner. A previous study demonstrated that, when administered by clinicians in school-based clinics, individual interpersonal psychotherapy is effective in reducing depressive symptoms and improving global and social functioning. This study will assess the effectiveness of group interpersonal psychotherapy (IPT-AG) versus treatment as usual (TAU) in improving depressive symptoms of adolescents in school-based health clinics.

Participants in this 16-week single-blind study will be randomly assigned to receive either IPT-AG or TAU in a school-based clinic. Participants assigned to receive IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. Study visits will occur at baseline and Weeks 4, 8, 12, and 16, or upon early termination. At the end of 16 weeks, participants assigned to receive IPT-AG will continue in a maintenance program in which they will receive IPT-AG once a month for an additional 6 months. All participants will also be assessed 6 and 12 months post-treatment to measure depressive symptoms, global and social functioning, satisfaction with care, and utilization of other services.

Conditions

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Depression

Keywords

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Major Depression Dysthymic Disorder Adjustment Disorder With Depressed Mood Depressive Disorder Not Otherwise Specified Adolescent Psychotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Participants will receive treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.

2

Participants will receive group interpersonal psychotherapy for depressed adolescents

Group Type EXPERIMENTAL

Group interpersonal psychotherapy for depressed adolescents (IPT-AG)

Intervention Type BEHAVIORAL

Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. Sessions will focus on problems in interpersonal relationships.

Interventions

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Group interpersonal psychotherapy for depressed adolescents (IPT-AG)

Participants assigned to IPT-AG will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. Sessions will focus on problems in interpersonal relationships.

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

TAU will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
* Score of 24 or greater on the CES-D
* Score between 10 and 28 on the HRSD
* Score of 65 or less on the C-GAS
* English-speaking
* Parental or legal guardian consent to participate

Exclusion Criteria

* Actively suicidal
* Score greater than 28 on the HRSD
* Mentally retarded
* Any life threatening medical illness
* Meets diagnostic criteria for current substance abuse, schizophrenia, or bipolar disorder
* Any evidence of psychosis, conduct disorder, or active eating disorder
* Currently in active treatment for depression
* Taking antidepressant medication at the time of baseline assessment
* Recent death of someone close
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura H. Mufson, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute-Columbia University College of Physicians and Surgeons

Countries

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United States

Other Identifiers

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R01MH073640

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 84-CTS

Identifier Type: -

Identifier Source: secondary_id

R01 MH73640, #5037

Identifier Type: -

Identifier Source: org_study_id