NCT00401102

Brief Summary

The purpose of this study is to examine the feasibility of using Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) to treat adolescents who are experiencing symptoms of depression and are engaging in non-suicidal self-injurious behaviors. The trial will include recruiting 10 particpants, administering 12-sessions of individual IPT-A, and determining how the IPT-A protocol needs to be amended to adequately address the self-injury in addition to depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 depression

Timeline
Completed

Started Nov 2006

Typical duration for phase_1 depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 28, 2013

Completed
Last Updated

January 28, 2013

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

November 15, 2006

Results QC Date

December 20, 2012

Last Update Submit

December 20, 2012

Conditions

DepressionSelf-injurious Behavior

Keywords

self-injurious behaviordepressionadolescentspsychotherapy

Outcome Measures

Primary Outcomes (5)

  • CGI

    1 week

  • C-GAS

    1 month

  • CDRS

    1 week

  • Self-Injurious Thoughts and Behaviors Interview

    8 weeks

  • Self-injury Monitoring Card

    1 month

Secondary Outcomes (2)

  • Beck Depression Inventory

    2 weeks

  • Multidimensional Anxiety Scale for Children

    recently

Study Arms (1)

Interpersonal psychotherapy

OTHER

All participants received interpersonal psychotherapy adapted for self-injury

Behavioral: Interpersonal Psychotherapy for Depressed Adolescents

Interventions

Interpersonal Psychotherapy for Depressed AdolescentsBEHAVIORAL

Open clinical trial of IPT-ASI for depressed and self-injuring adolescents, 12-18 years. Goal is to assess feasibility of using IPT-A protocol for teens with co-morbid depression and self-injury. All eligible participants receive 12 weeks of individual IPT-ASI with optional monthly booster sessions. IPT-ASI is a psychosocial intervention that focuses on the importance of interpersonal relationships in relation to psychological functioning. The first phase (4 weeks) includes a review of depression and self-injury symptoms, psycho-education about depression and self-injury, and a detailed assessment of the patient's important interpersonal relationships. The middle phase (weeks 5-9) involves interpersonal skill building, including communication skills, affect identification and expression, problem solving. The final phase ( weeks 10-12) involves review of skills, generalization of skills to other relationships, termination.

Interpersonal psychotherapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years of age
  • Diagnosis of MDD, Dysthymic Disorder, Depressive Disorder NOS, Adjustment Disorder with depressed Mood
  • Non-suicidal self-injurious behavior
  • CDRS \>= 36
  • C-GAS \<= 65
  • English speaking patient
  • One English speaking caregiver -

You may not qualify if:

  • Suicide attempt within past 6 months or actively suicidal
  • Severe incident of non-suicidal self-injury in past 3 months
  • Severe episode of MDD
  • Treatment resistant non-suicidal self-injury
  • Frequent non-suicidal self-injury
  • Mentally retarded
  • Current diagnosis of: PTSD, OCD, Schizophrenia, Bipolar Disorder, Psychosis, Substance Dependence, ADHD
  • Current substance use
  • Currently in active treatment for same condition
  • Currently taking antidepressant medication
  • Medical illness likely to interfere with treatment -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

DepressionSelf-Injurious Behavior

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Colleen Jacobsonn
Organization
Iona College
cjacobson@iona.edu
646-207-3563

Study Officials

  • Colleen Jacobson, PhD

    NYSPI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 28, 2013

Results First Posted

January 28, 2013

Record last verified: 2012-12

Locations

US(1)