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Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury

An Open-clinical Trial of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) for Depressed Adolescents Engaged in Non-suicidal Self-injury

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00401102
Acronym
IPT-ASI
Enrollment
10
Registered
2006-11-17
Start date
2006-11-30
Completion date
2009-09-30
Last updated
2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Self-injurious Behavior

Keywords

self-injurious behavior, depression, adolescents, psychotherapy

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.

Interventions

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.

Sponsors

MINT: Mental Health Initiative
CollaboratorOTHER
New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frame
C-GAS1 month
Self-Injurious Thoughts and Behaviors Interview8 weeks
Self-injury Monitoring Card1 month
CGI1 week
CDRS1 week

Secondary

MeasureTime frame
Multidimensional Anxiety Scale for Childrenrecently
Beck Depression Inventory2 weeks

Countries

United States

Participant flow

Participants by arm

ArmCount
Group 1
All participants recieved Interpersonal psychotherapy
12
Total12

Baseline characteristics

CharacteristicGroup 1
Age, Categorical
<=18 years
12 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age Continuous14.5 years
STANDARD_DEVIATION 1.3
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

CDRS

Time frame: 1 week

Primary

C-GAS

Time frame: 1 month

Primary

CGI

Time frame: 1 week

Primary

Self-Injurious Thoughts and Behaviors Interview

Time frame: 8 weeks

Population: Data for all subjects who completed the study was examined - however because this was a small pilot study and only 5 subjects completed treatment, no statistical tests were completed.

ArmMeasureValue (MEAN)Dispersion
Group 1Self-Injurious Thoughts and Behaviors Interview0.4 episodes of self-injury past monthStandard Deviation 0.9
Primary

Self-injury Monitoring Card

Time frame: 1 month

Secondary

Beck Depression Inventory

Time frame: 2 weeks

Secondary

Multidimensional Anxiety Scale for Children

Time frame: recently

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026