Mobile Mental Health Apps for Suicide Prevention

Depression Clinical Trial

Official title:

Acceptability, Usability and Effectiveness of Mental Health Apps for Suicide Prevention in Essential Workers and the Unemployed During SARS-CoV-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536935
• Other study ID #: STUDY00010842
• Secondary ID: 5P50MH115837-03
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: October 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 838
• Est. completion date: June 20, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Emotional Regulation
• Suicide

Intervention

Behavioral:
• Mobile Mental Health App - 1
Free mobile mental health application that focuses on meditation
• Mobile Mental Health App - 2
Free mobile mental health application that assists with coping with COVID-19
• Mobile Mental Health App - 3
Free mobile mental health application that focuses on positive psychology.
• Mobile Mental Health App - 4
Free mobile application that addresses mental health issues through mood tracking

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PARS EQ-5D	Standardized measure of health status with a total score range of 0 - 1. Maximum score of one indicates the best health state.	PARS EQ-5D at RCT baseline and RCT follow-up; duration of 4 weeks.
Other	CAGE-AID	Standardized measure of alcohol/drug use with a total score range of 0 - 4. Higher scores indicate higher risk for substance use.	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.
Other	Brief Resilience Scale (BRS)	The Brief Resilience Scale (BRS) is a 6-item, self-reported measure of an individual's ability to bounce back, resist illness, adapt to stress, or thrive in the face of adversity. Responses for all 6 items are on a scale of 1-5, with a total mean score ranging from 1 to 5. Higher score indicates higher resilience.	Participants will complete the BRS at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Other	Defeat Scale	Gilbert and Allan (1998) designed the items on this scale in order to depict a sense of failed struggle and losing rank. This measure requests participants to respond to 16 items on a 5-point Likert scale (ranging from 0 = 'Never' to 4 = 'Always') asking them how much they had felt defeated in the previous seven days, for example item 1 'I feel that I have not made it in life'. This scale has very high internal consistency with Alpha coefficients of 0.94 for females and 0.93 for males in both groups, furthermore reliability of 0.94 for students and 0.93 for depressed group. Total score can range from 0 to 64. Higher scores indicate higher levels of defeat.	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.
Other	Entrapment Scale	This 16-item entrapment scale asks participants to indicate on a 5-point scale the degree to which the items represent their thoughts and feelings. The response options are 0 = 'not at all like me', 1 = 'a little bit like me', 2 = 'moderately like me', 3= 'quite a bit like me' and 4 = 'extremely like me'. Gilbert and Allan (1998) reported high levels of internal consistency for both student and depressed groups, with Cronbach's alphas respectively of .93 and .86 in Internal Entrapment, and .88 and .89 in External Entrapment. Total score can range from 0 to 64. Higher scores indicate higher levels of entrapment.	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.
Other	Interpersonal Needs Questionnaire	Brief questionnaire that asks respondents to think about themselves and other people, based on the respondent's current beliefs and experiences. Higher scores indicate higher levels of thwarted belongingness (subscale range 9 to 63) and perceived burdensomeness (subscale range 9 to 63).	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.
Other	Loneliness and Social Distress Scale	No data displayed because outcome measure data was not collected therefore zero total participants analyzed.	Loneliness and Social Distress Scale at 4 weeks
Primary	Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) consists of 9 depression items and one disability item. Each item is associated with a DSM symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time, with a total sum score ranging from 0 - 27. Higher scores indicate higher depression symptom severity.	PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.
Primary	Generalized Anxiety Disorder (7-Item) Scale (GAD-7)	The Generalized Anxiety Disorder Scale (GAD-7) is a 7- item screener for generalized anxiety. It consists of items related to generalized anxiety disorder. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks to crease a total sum score ranging from 0 - 21. The scale is a valid screener for generalized anxiety symptoms. Higher scores indicate higher anxiety symptom severity.	GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks.
Primary	Brief Difficulties With Emotional Regulation Scale (DERS)	The Brief Difficulties with Emotional Regulation Scale (DERS) is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Total scores range from 18 - 90 with higher scores indicate more difficulty in emotion regulation.	DERS at RCT baseline and RCT follow-up; duration of four weeks.
Primary	Suicidal Behavioral Questionnaire-Revised (SBQ-R)	The suicidal behavioral questionnaire revised (SBQ-R) is a self-report questionnaire designed to identify risk factors for suicide. Total scores range from 3 to 18, with higher scores indicate indicating higher risk of suicidal behavior.	SBQ-R RCT baseline and RCT follow-up; duration of four weeks.
Secondary	Acceptability of Intervention Measure (AIM)	This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, with higher scores indicating higher acceptability. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.	Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Secondary	Intervention Appropriateness Measure (IAM)	This is a four item measure of intervention appropriateness, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, with higher scores indicating higher appropriateness. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.	Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Secondary	Intervention Usability Scale (IUS)	The Intervention Usability Scale (IUS) is a 10-item measure that assesses intervention usability through its likeability, learnability, difficulty, need for support, system integration, and efficiency. The measure is based on the System Usability Scale (SUS), a standardized, normed measure in industry for digital tools. Total scores can range from 0 - 100 with higher scores indicate higher levels of usability.	Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Secondary	Feasibility of Intervention Measure (FIM)	This is a four item measure of intervention feasibility, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized. High scores indicate higher levels of feasibility. No data displayed because outcome measure data was not collected therefore zero total participants analyzed.	Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.