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Technology Assisted Programs That Promote Mental Health for Teenagers (ProjectTECH)

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ClinicalTrials.gov Identifier: NCT01912729
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

Condition or disease Intervention/treatment
Depression Behavioral: Networked Peer Support with Peer Guide Behavioral: Networked Peer Support with Clinician Coach

Detailed Description:
The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Technology Assisted Intervention for the Treatment and Prevention of Depression
Study Start Date : January 2016
Primary Completion Date : June 2016
Study Completion Date : July 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Networked Peer Support with Peer Guide
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Behavioral: Networked Peer Support with Peer Guide
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
Experimental: Networked Peer Support with Clinician Coach
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Behavioral: Networked Peer Support with Clinician Coach
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
No Intervention: Wait List Control
Participants may be asked to wait for up to 8 weeks until minimum group size is met. After 4 weeks from baseline, if a group has not yet started, we will conduct another assessment. These participants will serve as the Wait List Control group.


Outcome Measures

Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Change from baseline to up to 8 weeks ]
    Change in self-reported depressive symptom severity from baseline to end of treatment

  2. Adherence to the application [ Time Frame: Change from baseline to up to 8 weeks ]
    Number of times accessed and time to last use


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS).
  • Is familiar with the use of computers and the Internet, as well as mobile phones
  • Is able to speak and read English
  • Is between 14-19 years of age

Exclusion Criteria:

  • Is currently taking an antidepressant medication or has taken one in the previous 3 months
  • Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis.
  • Is severely suicidal (has ideation, plan, and intent in the past 12 months) .
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): NCT01912729


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
More Information

Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01912729     History of Changes
Other Study ID Numbers: P20MH090318 STU00056069
P20MH090318 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by David Mohr, Northwestern University:
Depression prevention
Technology Assisted
Adolescents
Peer networked

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders