Brief Online Help-seeking Barrier Reduction Intervention

• Sponsor: Harvard University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03633825
• Collaborator: (none)
• Enrollment: 39,450
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 29286.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 10, 2017
• Actual Primary Completion Date: Sep 20, 2017
• Actual Study Completion Date: Sep 20, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Use of Crisis-referrals [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" [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard University	Cambridge	Massachusetts	United States	02138

Sponsors and Collaborators

• Harvard University

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Aug 14, 2018
• Study Protocol - Aug 31, 2017

More Information

Publications

None provided.

• Responsible Party: Adam Jaroszewski, Principal Investigator, Harvard University
• ClinicalTrials.gov Identifier: NCT03633825
• Other Study ID Numbers: IRB17-1303
• First Posted: Aug 16, 2018
• Last Update Posted: Aug 12, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Adam Jaroszewski, Principal Investigator, Harvard University: suicide; mental health crisis; crisis referrals; help-seeking; risk assessment; treatment barrier
• Additional relevant MeSH terms: Suicide

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 39,450 Koko users who signed up for the service between August 10, 2017 and September 20, 2017. Koko (née Panoply) provides safety services for large online social networks.
Pre-assignment Detail	All potential participants (N=39,450) screened for eligibility were considered enrolled. Potential participants were randomized upon accessing the platform, not later when identified as being in-crisis, because we used the platform's extant, AB-testing randomization tool. No other AB-tests were on the platform during the study period.

Arm/Group Title	Control	Intervention
Arm/Group Description	Control Condition: Users in the control condition experienced the Koko digital platform as usual.	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 overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/concerns related to each barrier. For example, a previous study among Koko users found that a common concern was that calls to lifelines invariably result in visits by the police. 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.
Period Title: Enrollment
STARTED	19838	19612
COMPLETED	805	775
NOT COMPLETED	19033	18837
Period Title: Enrollment
STARTED	805	775
COMPLETED	805	775
NOT COMPLETED	0	0
Period Title: Enrollment
STARTED	805	775
COMPLETED	327	325
NOT COMPLETED	478	450
Period Title: Enrollment
STARTED	327	325
COMPLETED	327	325
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Intervention	Total
Arm/Group Description	Control Condition: Users in the control condition experienced the Koko digital platform as usual.	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 overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/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. 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.	Total of all reporting groups
Overall Participants	805	775	1580
Age (years) [Mean (Standard Deviation) ]
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Control Condition: Users in the control condition experienced the Koko digital platform as usual.	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 overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/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. 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.
Measure Participants	327	325
Count of Participants [Participants]	130 16.1%	159 20.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=.02
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 1.03 to 1.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good"
Description	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.
Time Frame	5 hours post intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Control Condition: Users in the control condition experienced the Koko digital platform as usual.	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 overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/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. 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.
Measure Participants	327	325
Count of Participants [Participants]	250 31.1%	234 30.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=.19
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.91 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	31 days.
Arm/Group Title	Control		Intervention
Arm/Group Description	Control Condition: Users in the control condition experienced the Koko digital platform as usual.		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 overcome the potential barrier(s) they selected. By exploring various barriers, users could read brief messages designed to dispel common misconceptions/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. 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.
All Cause Mortality
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/805 (0%)		0/775 (0%)
Serious Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/805 (0%)		0/775 (0%)
Other (Not Including Serious) Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/805 (0%)		0/775 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.