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

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ClinicalTrials.gov Identifier: NCT02429674
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eleanor McGlinchey, New York State Psychiatric Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: TranS-C and IPT-A Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances
Study Start Date : February 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
TranS-C and IPT-A
12 sessions of weekly outpatient psychotherapy for adolescent depression.
Behavioral: TranS-C and IPT-A
The goal of IPT-A is to decrease depressive symptoms by focusing on current interpersonal difficulties and helping the adolescent improve his or her relationships and interpersonal interactions. This is accomplished through psychoeducation about the adolescent's depression and its link to interpersonal relationships, review of the adolescent's significant relationships, identification of interpersonal problem areas on which to focus the treatment, development of interpersonal problem solving and communication skills, and role-playing. The sleep disturbances intervention will include several modules selected because they are successful treatments for insomnia, and/or may help promote adherence to some of the recommendations related to sleep.
Other Name: Transdiagnostic Sleep and Circadian treatment and IPT-A




Primary Outcome Measures :
  1. Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS) [ Time Frame: Week 12 ]
    Reduction in depression symptoms


Secondary Outcome Measures :
  1. Change from Baseline in sleep using actigraphy estimated sleep variables [ Time Frame: Week 12 ]
    Reduction in sleep difficulties and increase in sleep duration

  2. Change from baseline in Cytokine levels found in saliva [ Time Frame: Week 12 ]
    Reduction in inflammatory markers



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429674


Contacts
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Contact: Eleanor McGlinchey, PhD 646 774-5859 mcglinc@nyspi.columbia.edu
Contact: Amir Levine, MD 646-774-7331 alevine@nyspi.columbia.edu

Locations
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United States, New York
Pediatric Anxiety and Mood Research Clinic, New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Eleanor McGlinchey, Ph.D.    646-774-5859    mcglinc@nyspi.columbia.edu   
Principal Investigator: Eleanor L McGlinchey, Ph.D.         
Sub-Investigator: Laura Mufson, Ph.D.         
Sub-Investigator: Amir Levine, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Eleanor L McGlinchey, Ph.D. New York State Psychiatric Institute

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Responsible Party: Eleanor McGlinchey, Assistant Professor of Clinical Psychology in Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02429674     History of Changes
Other Study ID Numbers: #7089
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eleanor McGlinchey, New York State Psychiatric Institute:
Depression
Adolescence
Additional relevant MeSH terms:
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Sleep Wake Disorders
Dyssomnias
Parasomnias
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms