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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: TranS-C and IPT-A
    • 12 sessions of weekly outpatient psychotherapy for adolescent depression.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in Depression symptom score on the Children’s Depression Rating Scale (CDRS)
    • Time Frame: Week 12
    • Reduction in depression symptoms

Secondary Measures

  • Change from Baseline in sleep using actigraphy estimated sleep variables
    • Time Frame: Week 12
    • Reduction in sleep difficulties and increase in sleep duration
  • Change from baseline in Cytokine levels found in saliva
    • Time Frame: Week 12
    • Reduction in inflammatory markers

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • New York State Psychiatric Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eleanor McGlinchey, Assistant Professor of Clinical Psychology in Psychiatry – New York State Psychiatric Institute
  • Overall Official(s)
    • Eleanor L McGlinchey, Ph.D., Principal Investigator, New York State Psychiatric Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.