- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03633825
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB17-1303
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.
Clinical Trials on Suicide and Depression
-
Zagazig UniversityRecruitingSuicide and DepressionEgypt
-
Stanford UniversityCompletedDepression and SuicideUnited States
-
Centre Hospitalier Henri LaboritRecruitingDepression and SuicideFrance
-
University of Texas Southwestern Medical CenterNational Institute of Mental Health (NIMH)CompletedSuicide, Attempted | Suicide and Depression | Suicide ThreatUnited States
-
University of Texas Southwestern Medical CenterEnrolling by invitationDepressive Disorder | Depression | Suicidal Ideation | Suicide, Attempted | Suicide | Depressive Symptoms | Depression, Anxiety | Depressive Episode | Depression and Suicide | Depression, TeenUnited States
-
University of MemphisRecruitingSuicide Ideation | Suicidal Behaviors | Depression/AnxietyUnited States
-
Institut National de la Santé Et de la Recherche...National Agency of Public Health; Institut de Recherche en Santé Publique,... and other collaboratorsCompletedAnxiety Disorders | Psychological Distress | Suicide and Depression | Local Authorities PromotionFrance
-
University of PittsburghUniversity of Oregon; National Institute of Mental Health (NIMH); Children's... and other collaboratorsRecruitingAdolescent Behavior | Suicide and DepressionUnited States
-
Eli Lilly and CompanyCompleted
-
University Hospital, MontpellierINSERM U960 - Cognitive Neuroscience Laboratory - Paris, FranceTerminatedDepression | History of Suicide AttemptFrance
Clinical Trials on Brief help-seeking barrier reduction intervention
-
113 Suicide PreventionCompleted
-
University of PennsylvaniaPfizer; Pennsylvania Department of Health; Dickinson CollegeCompleted
-
Florida State UniversityMilitary Suicide Research ConsortiumCompletedMilitary Service Members at Elevated Suicide RiskUnited States
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Kwong Wah... and other collaboratorsRecruitingSmoking Cessation | Mobile Health | Post-dischargeChina
-
Radboud University Medical CenterCompletedRandomized Controlled Trial | Mindfulness | Psychopathology | Health PersonnelNetherlands
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDepressive Disorder | ViolenceUnited States
-
Harvard UniversityTerminatedSuicide | Distress, EmotionalUnited States
-
City, University of LondonCompletedStress | AnxietyUnited Kingdom
-
The University of Hong KongNot yet recruiting
-
The University of Hong KongRecruitingThe "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke ExposureSmoking Cessation | Second Hand Tobacco SmokeChina