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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00401102
Other study ID # 5332
Secondary ID
Status Completed
Phase Phase 1
First received November 15, 2006
Last updated December 20, 2012
Start date November 2006
Est. completion date September 2009

Study information

Verified date December 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Engagement in non-suicidal self-injury (NSSI), purposefully harming oneself without the conscious intent to die such as cutting or burning, is pervasive among adolescents. Lifetime prevalence estimates among community samples of high school students range from 13.0% to 23.2%. Despite the significance of this public health problem, there are no known interventions that successfully reduce the frequency of NSSI or prevent NSSI in adolescents. The goal of the current study is to develop an effective psychosocial intervention for NSSI among adolescents who are engaging in self-injury and have a depressive disorder. Specifically, we will amend Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), a psychotherapy that has demonstrated efficacy in treating depressed adolescents (Mufson et al., 1994, 1999, 2004), for use with adolescents with depression who are engaging in NSSI, with the ultimate goal of curing the depression and NSSI. Ten participants will be administered IPT-A and assessed several times throughout the course of the trial. It is expected that IPT-A will be a useful treatment for co-morbid depression and self-injury, although adaptations to the protocol will likely be needed to address the behavioral aspect of the self-injury. Data analyses will be descriptive in nature and involve examining the individual trajectories of depression and NSSI over time. The data obtained from the current study will lay the groundwork for an ultimate randomized controlled trial in which we plan to compare IPT-A versus nondirective supportive therapy in the treatment of co-morbid depression and NSSI.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

1. 12 to 18 years of age

2. Diagnosis of MDD, Dysthymic Disorder, Depressive Disorder NOS, Adjustment Disorder with depressed Mood

3. Non-suicidal self-injurious behavior

4. CDRS >= 36

5. C-GAS <= 65

6. English speaking patient

7. One English speaking caregiver -

Exclusion Criteria:

1. Suicide attempt within past 6 months or actively suicidal

2. Severe incident of non-suicidal self-injury in past 3 months

3. Severe episode of MDD

4. Treatment resistant non-suicidal self-injury

5. Frequent non-suicidal self-injury

6. Mentally retarded

7. Current diagnosis of: PTSD, OCD, Schizophrenia, Bipolar Disorder, Psychosis, Substance Dependence, ADHD

8. Current substance use

9. Currently in active treatment for same condition

10. Currently taking antidepressant medication

11. Medical illness likely to interfere with treatment -

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Interpersonal Psychotherapy for Depressed Adolescents
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.

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute MINT: Mental Health Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CGI 1 week Yes
Primary C-GAS 1 month No
Primary CDRS 1 week Yes
Primary Self-Injurious Thoughts and Behaviors Interview 8 weeks No
Primary Self-injury Monitoring Card 1 month No
Secondary Beck Depression Inventory 2 weeks No
Secondary Multidimensional Anxiety Scale for Children recently No
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