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

NCT02429674 | Completed

• 1 other identifier: #7089
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Adolescence

Outcome Measures

Primary Outcomes (1)

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

  Reduction in depression symptoms

  Week 12

Secondary Outcomes (2)

• Change from Baseline in sleep using actigraphy estimated sleep variables

  Week 12

• Change from baseline in Cytokine levels found in saliva

  Week 12

Study Arms (1)

TranS-C and IPT-A

OTHER

12 sessions of weekly outpatient psychotherapy for adolescent depression.

Behavioral: TranS-C and IPT-A

Interventions

TranS-C and IPT-A BEHAVIORAL

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.

Also known as: Transdiagnostic Sleep and Circadian treatment and IPT-A

TranS-C and IPT-A

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

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

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Eleanor L McGlinchey, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology in Psychiatry

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 29, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)