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Brief Online Help-seeking Barrier Reduction Intervention

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ClinicalTrials.gov Identifier: NCT03633825
Recruitment Status : Completed
First Posted : August 16, 2018
Results First Posted : April 17, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Jaroszewski, Harvard University

Brief Summary:
Objective: Mental illness is a leading cause of disease burden; however, many barriers prevent people from seeking mental health services. Technological innovations may improve the ability to reach under-served populations by overcoming many existing barriers. The investigators evaluated a brief, automated risk assessment and intervention platform designed to increase the use of crisis resources provided to individuals who were online and in crisis. Hypothesis: The investigators hypothesized that individuals assigned to the intervention condition would report using crisis resources at higher rates than individuals in the control condition. Method: Participants, users of the digital mental health app Koko, were randomly assigned to treatment or control conditions upon accessing the app and were included in the study after their posts were identified by machine learning classifiers as signaling a current mental health crisis. Participants in the treatment condition received a brief Barrier Reduction Intervention (BRI) designed to increase the use of crisis service referrals provided on the app. Participants were followed-up several hours later to assess the use of crisis services.

Condition or disease Intervention/treatment Phase
Crisis Intervention Suicide and Depression Behavioral: Brief help-seeking barrier reduction intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of an Online Machine Learning-Driven Risk Assessment and Intervention Platform for Increasing the Use of Crisis Services
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
No Intervention: Control
Experimental: Intervention Behavioral: Brief help-seeking barrier reduction intervention
The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended to help the user overcome the potential barrier(s) they selected. By exploring the menu of barriers, users could read brief messages designed to dispel common misconceptions or concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police or other emergency services. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.




Primary Outcome Measures :
  1. Number of Participants Reporting Use of Crisis-referrals [ Time Frame: 5 hours post intervention ]
    The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline)


Secondary Outcome Measures :
  1. Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good" [ Time Frame: 5 hours post intervention ]
    The number of participants in the treatment versus control conditions reporting that their experience on the Koko digital platform was "good" versus "bad" using a two-option response question.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants identified as experiencing a mental health crisis by a hybrid human-machine computation system evaluating semantic content of posts made on digital platforms.

Exclusion Criteria:

  • Participants who were not identified as experiencing a mental health crisis.

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): NCT03633825


Locations
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United States, Massachusetts
Harvard University
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Harvard University
  Study Documents (Full-Text)

Documents provided by Adam Jaroszewski, Harvard University:
Statistical Analysis Plan  [PDF] August 14, 2018
Study Protocol  [PDF] August 31, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adam Jaroszewski, Principal Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT03633825     History of Changes
Other Study ID Numbers: IRB17-1303
First Posted: August 16, 2018    Key Record Dates
Results First Posted: April 17, 2019
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Jaroszewski, Harvard University:
suicide
mental health crisis
crisis referrals
help-seeking
risk assessment
treatment barrier
Additional relevant MeSH terms:
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Suicide
Behavioral Symptoms
Self-Injurious Behavior