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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TranS-C and IPT-A
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Adolescence

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pediatric Anxiety and Mood Research Clinic, New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TranS-C and IPT-A

Arm Description

12 sessions of weekly outpatient psychotherapy for adolescent depression.

Outcomes

Primary Outcome Measures

Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS)
Reduction in depression symptoms

Secondary Outcome Measures

Change from Baseline in sleep using actigraphy estimated sleep variables
Reduction in sleep difficulties and increase in sleep duration
Change from baseline in Cytokine levels found in saliva
Reduction in inflammatory markers

Full Information

First Posted
April 22, 2015
Last Updated
January 28, 2021
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02429674
Brief Title
The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances
Official Title
The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TranS-C and IPT-A
Arm Type
Other
Arm Description
12 sessions of weekly outpatient psychotherapy for adolescent depression.
Intervention Type
Behavioral
Intervention Name(s)
TranS-C and IPT-A
Other Intervention Name(s)
Transdiagnostic Sleep and Circadian treatment and IPT-A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS)
Description
Reduction in depression symptoms
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in sleep using actigraphy estimated sleep variables
Description
Reduction in sleep difficulties and increase in sleep duration
Time Frame
Week 12
Title
Change from baseline in Cytokine levels found in saliva
Description
Reduction in inflammatory markers
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor L McGlinchey, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Anxiety and Mood Research Clinic, New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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