Brief Online Help-seeking Barrier Reduction Intervention

April 10, 2023 updated by: Adam Jaroszewski, Harvard University

Randomized Controlled Trial of an Online Machine Learning-Driven Risk Assessment and Intervention Platform for Increasing the Use of Crisis Services

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

39450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Harvard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 hours post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 hours post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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