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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429674
• Other study ID #: #7089
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 2021

Study information

• Verified date: January 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dyssomnias
• Parasomnias

Intervention

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.

Locations

Country	Name	City	State
United States	Pediatric Anxiety and Mood Research Clinic, New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS)	Reduction in depression symptoms	Week 12
Secondary	Change from Baseline in sleep using actigraphy estimated sleep variables	Reduction in sleep difficulties and increase in sleep duration	Week 12
Secondary	Change from baseline in Cytokine levels found in saliva	Reduction in inflammatory markers	Week 12