Clinical trial NCT00401102: Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury
Official title: An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged in Non-suicidal Self-injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Self-injurious Behavior
Keywords: self-injurious behavior
depression
adolescents
psychotherapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: MINT: Mental Health Initiative
First posted: 2006-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: CGI
timeFrame: 1 week
measure: C-GAS
timeFrame: 1 month
measure: CDRS
timeFrame: 1 week
measure: Self-Injurious Thoughts and Behaviors Interview
timeFrame: 8 weeks
measure: Self-injury Monitoring Card
timeFrame: 1 month
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 2 weeks
measure: Multidimensional Anxiety Scale for Children
timeFrame: recently
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI
name: Colleen Jacobson, PhD
role: PRINCIPAL_INVESTIGATOR
References: