Mobile Mental Health Apps for Suicide Prevention

NCT ID: NCT04536935

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 838 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-06-20

Brief Summary

Access to mental health care by essential workers and the unemployed during the COVID19 pandemic has been challenging. Usual access to mental health care is limited by social distancing, and for many now unemployed due to closures of businesses, insurance is insufficient to cover the costs of mental health care. For these individuals who are at risk for suicide (isolation, unemployment, financial crisis plus past suicide attempts, significant mental health challenges), access to care is crucial and many maybe turning to online and accessible interventions, such as mental health apps and other online resources. Indeed, organizations such as the VA have already created free access mobile applications for mental health in anticipation of this need. Using Psyberguide, the investigators will identify the top ten free apps that address mental health issues and conduct a nation-wide evaluation of these apps with participants who are essential workers and unemployed with risk for suicide. Participants will first be surveyed about which strategies they have used to manage mental health issues, what apps and online tools they have used, and what usability challenges they have faced. The investigators will then ask a random sample of participant to engage in a randomized trial of these top-rated apps for 4 weeks. Apps will be rated on usability, acceptability, feasibility and effectiveness. Results from this trial will be quickly disseminated through several avenues: (1) the UWAC website and ALACRITY Centers network; (2) through CREATIV Lab's partnership with Mental Health America; (3) through the UW Center for Suicide Prevention and Recovery (CSPAR) and partnerships with other suicide focused organizations including Forefront, the American Foundation for Suicide Prevention, that American Association of Suicidology, the Rocky Mountain MIRECC, and the Defense Suicide Prevention Office and (4) through local partnership with King County and WA state contact tracers.

Detailed Description

Participants will be recruited nationally via Prolific. Investigators will aim to recruit 1,000 participants in the clinical trial who are essential workers and/or unemployed due to COVID-19 and have a past history of mental health issues or experiencing suicide ideation motivational risk factors to be randomized (250 per group) to one of the four apps. They will be asked to download their assigned app and use it for 4 weeks. After 4 weeks of use, participants will be asked to provide an evaluation of acceptability, feasibility and usability of the app, how often they used the app, and if they found the app helpful. Participants will also be asked to complete clinical outcome measures.

Conditions

Depression; Anxiety; Emotional Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 2: Mobile Mental Health App - 1

Participants randomized to a free mobile mental health application that focuses on meditation.

Group Type: ACTIVE_COMPARATOR

Mobile Mental Health App - 1

Intervention Type: BEHAVIORAL

Free mobile mental health application that focuses on meditation

Phase 2: Mobile Mental Health App - 2

Participants randomized to a free mobile mental health application that assists with coping with COVID-19.

Group Type: ACTIVE_COMPARATOR

Mobile Mental Health App - 2

Intervention Type: BEHAVIORAL

Free mobile mental health application that assists with coping with COVID-19

Phase 2: Mobile Mental Health App - 3

Participants randomized to a free mobile mental health application that focuses on positive psychology.

Group Type: ACTIVE_COMPARATOR

Mobile Mental Health App - 3

Intervention Type: BEHAVIORAL

Free mobile mental health application that focuses on positive psychology.

Phase 2: Mobile Mental Health App - 4

Participants randomized to a free mobile application that addresses mental health issues through mood tracking.

Group Type: ACTIVE_COMPARATOR

Mobile Mental Health App - 4

Intervention Type: BEHAVIORAL

Free mobile application that addresses mental health issues through mood tracking

Interventions

Mobile Mental Health App - 1

Free mobile mental health application that focuses on meditation

Intervention Type: BEHAVIORAL

Mobile Mental Health App - 2

Free mobile mental health application that assists with coping with COVID-19

Intervention Type: BEHAVIORAL

Mobile Mental Health App - 3

Free mobile mental health application that focuses on positive psychology.

Intervention Type: BEHAVIORAL

Mobile Mental Health App - 4

Free mobile application that addresses mental health issues through mood tracking

Intervention Type: BEHAVIORAL

Other Intervention Names

Calm; COVID Coach; 7 Cups of Tea; Beautiful Mood

Eligibility Criteria

Inclusion Criteria

Phase 1

• 19 years old and older
• Identify as an essential worker or unemployed due to COVID-19
• English-speaking
• Access to a mobile device (e.g. smartphone or tablet)
• Based in the United States

Phase 2

• 19 years old and older
• Scored at or above validated cut off scores in Phase 1 (PHQ-2>3; GAD-2>3; SBQ-R>7) or reported history of past suicide attempt
• Identify as an essential worker or unemployed due to COVID-19
• English-speaking
• Access to a mobile device (e.g. smartphone or tablet)
• Based in the United States

Exclusion Criteria

Phase 1

• Under the age of 19
• Neither an essential worker nor unemployed due to COVID-19
• Non-English speaking
• No access to a mobile device (e.g. smartphone or tablet)
• Not based in the United States

Phase 2

• Under the age of 19
• Did not score at or above validated cut off scores in Phase 1 (PHQ-2>3; GAD-2>3; SBQ-R>7) nor reported history of past suicide attempt
• Neither an essential worker nor unemployed due to COVID-19
• Non-English speaking
• No access to a mobile device (e.g. smartphone or tablet)
• Not based in the United States

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kate Comtois

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

Comtois KA, Mata-Greve F, Johnson M, Pullmann MD, Mosser B, Arean P. Effectiveness of Mental Health Apps for Distress During COVID-19 in US Unemployed and Essential Workers: Remote Pragmatic Randomized Clinical Trial. JMIR Mhealth Uhealth. 2022 Nov 7;10(11):e41689. doi: 10.2196/41689.

Reference Type: DERIVED

PMID: 36191176 (View on PubMed)

Mata-Greve F, Johnson M, Blanchard BE. A longitudinal examination of cultural risk factors of suicide and emotion regulation. Am J Orthopsychiatry. 2022;92(5):635-645. doi: 10.1037/ort0000629. Epub 2022 May 26.

Reference Type: DERIVED

PMID: 35617246 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P50MH115837-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010842

Identifier Type: -

Identifier Source: org_study_id