An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression
Overview
- Phase
- Phase 2
- Intervention
- Interpersonal Psychotherapy for Depressed Adolescents
- Conditions
- Depressive Disorder
- Sponsor
- University of Minnesota
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Children's Depression Rating Scale - Revised
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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 \[CDRS-R\])
- •Current impairment in psychosocial functioning (based on Children's Global Assessment Scale \[CGAS\])
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
Arms & Interventions
IPT-A Adaptive Treatment Strategy
Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).
Intervention: Interpersonal Psychotherapy for Depressed Adolescents
IPT-A Adaptive Treatment Strategy
Adolescents begin with an initial treatment plan of 12 weekly sessions of interpersonal psychotherapy for depressed adolescents (IPT-A). Depressive symptoms will be assessed at week 4 and week 8 of therapy. If an adolescent demonstrates an insufficient response at either time point, the adolescent will be randomized a second time to either an increased dose of IPT-A (sessions scheduled twice per week for 4 weeks;16 sessions total) or the addition of a selective serotonin reuptake inhibitor (SSRI).
Intervention: Selective Serotonin Reuptake Inhibitor
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.
Intervention: Usual Care
Outcomes
Primary Outcomes
Children's Depression Rating Scale - Revised
Time Frame: 16 weeks
Minimum value: 17 Maximum value: 113 Higher scores indicate worse outcome
Secondary Outcomes
- Children's Global Assessment Scale(16 weeks)