Group Interpersonal Psychotherapy for Depressed Adolescents in School-based Clinics

NCT00270244 | Completed Phase 2 DMC

• 3 other identifiers: R01 MH73640, #5037R01MH073640DSIR 84-CTS
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms as measured by the Hamilton Rating Scale for Depression (HRSD) and the Center for Epidemiological Studies-Depression Scale (CES-D)

  Measured at Month 18

• Overall impairment, as measured by the Global Assessment Scale for Children (C-GAS)

  Measured at Month 18

• Social functioning, as measured by the Social Adjustment Scale-Self-report (SAS-SR)

  Measured at Month 18

Secondary Outcomes (1)

• Short Acculturation Scale for Hispanics, CES-D, HRSD, C-GAS, Clinical Global Improvement, Inventory of Parent and Peer Attachment, Family Adaptation and Cohesions Evaluation Scales III, and the Penn Helping Alliance Questionnaire-Revised

  Measured at Month 18

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual (TAU)

2

EXPERIMENTAL

Participants will receive group interpersonal psychotherapy for depressed adolescents

Behavioral: Group interpersonal psychotherapy for depressed adolescents (IPT-AG)

Interventions

Group interpersonal psychotherapy for depressed adolescents (IPT-AG) 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.

2

Treatment as usual (TAU) BEHAVIORAL

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

1

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Dysthymic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Laura H. Mufson, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 26, 2005
• Study Start: December 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 30, 2011

Record last verified: 2011-12