Clinical trial NCT04536935: Mobile Mental Health Apps for Suicide Prevention
Official title: Acceptability, Usability and Effectiveness of Mental Health Apps for Suicide Prevention in Essential Workers and the Unemployed During SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Emotional Regulation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-03
Enrollment: 838
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.
measure: Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
timeFrame: GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks.
measure: Brief Difficulties With Emotional Regulation Scale (DERS)
timeFrame: DERS at RCT baseline and RCT follow-up; duration of four weeks.
measure: Suicidal Behavioral Questionnaire-Revised (SBQ-R)
timeFrame: SBQ-R RCT baseline and RCT follow-up; duration of four weeks.
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Intervention Usability Scale (IUS)
timeFrame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Other outcomes:
measure: PARS EQ-5D
timeFrame: PARS EQ-5D at RCT baseline and RCT follow-up; duration of 4 weeks.
measure: CAGE-AID
timeFrame: Participants will complete the CAGE-AID at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Brief Resilience Scale (BRS)
timeFrame: Participants will complete the BRS at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Defeat Scale
timeFrame: Participants will complete the Defeat Scale at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Entrapment Scale
timeFrame: Participants will complete the Entrapment Scale at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Interpersonal Needs Questionnaire
timeFrame: Participants will complete the Interpersonal Needs Questionnaire at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
measure: Loneliness and Social Distress Scale
timeFrame: Loneliness and Social Distress Scale at 4 weeks
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
citation: 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.
citation: 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.