The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:12 - 17
Updated:1/30/2019
Start Date:February 2015
End Date:June 2020
Contact:Eleanor McGlinchey, PhD
Email:mcglinc@nyspi.columbia.edu
Phone:646 774-5859

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The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents
(IPT-A) with depression works to change sleep and related biological markers found in saliva,
namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is
to understand the biological mechanisms of recovery from depression in order to assist in
selecting and guiding personalized psychotherapeutic interventions with the highest
likelihood of success for individual adolescents with depression.

The primary aim of this project is to examine whether adolescent depression and the
associated symptoms of sleep disturbance are best treated using an empirically supported
psychotherapy that is augmented with a sleep improvement module. Twenty adolescents (ages
12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive
disorder not otherwise specified, or adjustment disorder with depressed mood and also report
elevated levels of sleep disturbance will receive Interpersonal Psychotherapy for Depressed
Adolescents (IPT-A) with an adjunctive sleep module that is integrated throughout the
treatment. Identifying the best approach to treating both the adolescent's depression and the
commonly associated symptom of sleep disturbance will have significant implications for the
long-term outcomes of depressed adolescents. Moreover, identifying unique symptom and
biological profiles at the outset of treatment may enable doctors to predict treatment
outcome.

Inclusion Criteria:

- outpatient participant

- parent or legally authorized representative must provide consent and assent by the
participant

- Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria
for a depressive disorder

- Clinical Global Assessment Scale (C-GAS) < 65

- Quick Inventory of Depression Symptoms - Self Report 16 (QIDS-SR16) over 8 and less
than 24.

- English speaking

- significant sleep complaints

Exclusion Criteria:

- co-morbid psychiatric diagnosis of bipolar disorder, psychosis, autism spectrum
disorder, intellectual development disorder, conduct disorder or substance abuse
disorder

- any condition or illness such as uncontrolled seizure disorder, uncontrolled diabetes,
or any other conditions that represent as an inappropriate risk to the participant
and/or could confound the interpretation of the study

- currently in active evidence-based psychotherapy for the same condition

- currently taking medication for a psychiatric diagnosis that is not a stable dose (4
weeks on the same dose).

- currently considered at risk for suicide in the opinion of the study doctor, has made
a suicide attempt in the past 4 months, or is currently reporting active suicidal
ideation.

- history of alcohol or other substance abuse as defined by DSM-V within the last 6
months.

- evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless
legs or periodic limb movements during sleep

- sleep treatment that might confound the interpretation of sleep outcomes.
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Eleanor L McGlinchey, Ph.D.
Phone: 646-774-5859
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mi
from
New York, NY
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