An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Phase 2

Completed

• Conditions: Depressive Disorder
• Interventions: Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; Other: Usual Care; Drug: Selective Serotonin Reuptake Inhibitor

• Registration Number: NCT03222570
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Study Start: 2018-02-26
• Primary Completion: 2024-04-28
• Study Completion: 2024-04-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Meet DSM-V criteria for a primary diagnosis of Major Depressive Disorder, Persistent Depressive Disorder, or Depressive Disorder NEC
• Current significant depressive symptoms (based on Children's Depression Rating Scale - Revised [CDRS-R] & Beck Depression Inventory-II [BDI-II])
• Current impairment in psychosocial functioning (based on Children's Global Assessment Scale [CGAS])

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Exclusion Criteria

• Non English-speaking
• Meet DSM-V criteria for bipolar disorder, psychosis, anorexia nervosa, substance use disorder, autism spectrum disorder, or intellectual disability disorder.
• Adolescents who are actively suicidal with a plan and/or intent who are assessed to need a higher level of care than outpatient treatment due to safety risk will be referred for appropriate level of stabilization. Once stabilized, the adolescent can be re-evaluated for eligibility to participate in the study.
• Currently taking medication for a psychiatric diagnosis other than ADHD
• Females who are pregnant, breastfeeding, or having unprotected sexual intercourse, due to the possibility of randomization to treatment with an SSRI.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IPT-A - possible augment with addl IPT-A	Interpersonal Psychotherapy for Depressed Adolescents	Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, the dose of IPT-A will be increased by scheduling sessions twice per week for 4 weeks (16 sessions total).
IPT-A - possible augment with SSRI	Interpersonal Psychotherapy for Depressed Adolescents	Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, treatment will be augmented by adding a selective serotonin reuptake inhibitor (SSRI).
Usual Care	Usual Care	Therapists will implement therapy procedures that they usually use and believe to be effective in clinical practice. Therapists will use whatever methods they usually use to make decisions regarding the frequency of therapy sessions and whether to refer the adolescent to start an SSRI.
IPT-A - possible augment with SSRI	Selective Serotonin Reuptake Inhibitor	Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed systematically over the course of therapy. If an adolescent demonstrates an insufficient response to IPT-A at one of these assessments, treatment will be augmented by adding a selective serotonin reuptake inhibitor (SSRI).

Primary Outcome Measures

Name	Time	Method
Severity of depressive symptoms (Children's Depression Rating Scale - Revised)	36 weeks

Secondary Outcome Measures

Name	Time	Method
Level of Interpersonal functioning (aggregate of Conflict Behavior Questionnaire, Inventory of Parent and Peer Attachment - Revised, Issues Checklist, and parent and adolescent coded interpersonal behaviors during a conflict negotiation task)	36 weeks	Measures will be aggregated using latent factor analysis.

Trial Locations

Locations (1)

Institute for Translational Research in Children's Mental Health; 🇺🇸 Minneapolis, Minnesota, United States