NCT03633825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39,450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 17, 2019

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

August 14, 2018

Results QC Date

August 17, 2018

Last Update Submit

April 10, 2023

Conditions

Keywords

suicidemental health crisiscrisis referralshelp-seekingrisk assessmenttreatment barrier

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Use of Crisis-referrals

    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 Outcomes (1)

  • Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good"

    5 hours post intervention

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Brief help-seeking barrier reduction intervention

Interventions

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

  • Jaroszewski AC, Morris RR, Nock MK. Randomized controlled trial of an online machine learning-driven risk assessment and intervention platform for increasing the use of crisis services. J Consult Clin Psychol. 2019 Apr;87(4):370-379. doi: 10.1037/ccp0000389.

MeSH Terms

Conditions

SuicideDepression

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Principal Investigator
Organization
Harvard University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 16, 2018

Study Start

August 10, 2017

Primary Completion

September 20, 2017

Study Completion

September 20, 2017

Last Updated

April 12, 2023

Results First Posted

April 17, 2019

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations