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Trial record 11 of 65 for:    psychotherapy | Not yet recruiting Studies

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

This study is not yet open for participant recruitment.
Verified October 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03222570
First Posted: July 19, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition Intervention Phase
Depressive Disorder Behavioral: Interpersonal Psychotherapy for Depressed Adolescents Drug: Selective Serotonin Reuptake Inhibitor Other: Usual Care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Severity of depressive symptoms (Children's Depression Rating Scale - Revised) [ Time Frame: 36 weeks ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 36 weeks ]
    Measures will be aggregated using latent factor analysis.


Estimated Enrollment: 200
Anticipated Study Start Date: March 2018
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPT-A - possible augment with addl IPT-A
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).
Behavioral: Interpersonal Psychotherapy for Depressed Adolescents
IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.
Experimental: IPT-A - possible augment with SSRI
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).
Behavioral: Interpersonal Psychotherapy for Depressed Adolescents
IPT-A is an evidence-based intervention that aims to decrease depressive symptoms by helping adolescents improve their relationships and interpersonal interactions. It addresses one or more of four interpersonal problem areas: grief, role disputes, role transitions, and interpersonal deficits. The primary treatment techniques in IPT-A include emotion identification/expression, linking interpersonal events to mood, communication analysis, communication skill building, decision analysis, role playing, and assignment of interpersonal experiments (i.e. homework). In clinical trials, depressed adolescents treated with IPT-A demonstrated fewer depressive symptoms and better psychosocial functioning post-treatment than adolescents in control conditions.
Drug: Selective Serotonin Reuptake Inhibitor
Fluoxetine, escitalopram, citalopram, fluvoxamine, or sertraline
Active Comparator: 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.
Other: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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] & Beck Depression Inventory-II [BDI-II])
  • 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
  • Females who are pregnant, breastfeeding, or having unprotected sexual intercourse, due to the possibility of randomization to treatment with an SSRI.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222570


Contacts
Contact: Meredith Gunlicks-Stoessel, Ph.D. 612-273-9844 mgunlick@umn.edu

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03222570     History of Changes
Other Study ID Numbers: R01MH113748 ( U.S. NIH Grant/Contract )
First Submitted: July 13, 2017
First Posted: July 19, 2017
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data resulting from the proposed project will be shared via the National Database for Clinical Trials (NDCT).
Supporting Materials: Study Protocol
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators