Mobile Mental Health Apps for Suicide Prevention

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT04536935
Collaborator
National Institute of Mental Health (NIMH) (NIH)
3,000
1
4
6.6
452

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile Mental Health App - 1
  • Behavioral: Mobile Mental Health App - 2
  • Behavioral: Mobile Mental Health App - 3
  • Behavioral: Mobile Mental Health App - 4
N/A

Detailed Description

Participants will be recruited nationally via Prolific. Phase 1 will enroll 2,000 participants 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. Participants will be asked about their mental health needs, challenges they face accessing care, and strategies they have used to manage their mental health. All participants will then be shown App Store descriptions of ten apps that have received the highest rating by PsyberGuide, a non-profit company that consistently rates existing apps for their safety, data privacy and user ratings. Participants will provide initial impressions on the acceptability and feasibility of using these apps. The investigators will then ask participants if they would be willing to participate in a randomized trial (Phase 2) to test these apps, with the aim of recruiting 1000 participants. Participants will 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Acceptability, Usability and Effectiveness of Mental Health Apps for Suicide Prevention in Essential Workers and the Unemployed During SARS-CoV-2
Actual Study Start Date :
Nov 30, 2020
Actual Primary Completion Date :
Jun 20, 2021
Actual Study Completion Date :
Jun 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Phase 2: Mobile Mental Health App - 1

Behavioral: Mobile Mental Health App - 1
Free mobile mental health application that focuses on meditation
Other Names:
  • Calm
  • Active Comparator: Phase 2: Mobile Mental Health App - 2

    Behavioral: Mobile Mental Health App - 2
    Free mobile mental health application that assists with coping with COVID-19
    Other Names:
  • COVID Coach
  • Active Comparator: Phase 2: Mobile Mental Health App - 3

    Behavioral: Mobile Mental Health App - 3
    Free mobile mental health application that focuses on positive psychology.
    Other Names:
  • 7 Cups of Tea
  • Active Comparator: Phase 2: Mobile Mental Health App - 4

    Behavioral: Mobile Mental Health App - 4
    Free mobile application that addresses mental health issues through mood tracking
    Other Names:
  • Beautiful Mood
  • Outcome Measures

    Primary Outcome Measures

    1. Patient Health Questionnaire (PHQ-9) [Change from baseline PHQ-9 at 4 weeks]

      The PHQ-9 consists of 9 depression items and one disability item. Each time 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.

    2. Generalized Anxiety Disorder (7-Item) Scale (GAD-7) [Change from baseline GAD-7 at 4 weeks]

      A 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD.

    3. Brief Difficulties with Emotional Regulation Scale (DERS) [Change from baseline DERS at 4 weeks]

      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%]"). Higher scores indicate more difficulty in emotion regulation.

    Secondary Outcome Measures

    1. Acceptability of Intervention Measure (AIM) [4 weeks]

      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. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.

    2. Intervention Appropriateness Measure (IAM) [4 weeks]

      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. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.

    3. Feasibility of Intervention Measure (FIM) [4 weeks]

      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. Participants will complete this measure after 4 weeks of using the mobile mental health app to which they are randomized.

    Other Outcome Measures

    1. PARS EQ-5D [Change from baseline PARS EQ-5D at 4 weeks]

      Standardized measure of health status

    2. CAGE-AID [Change from baseline CAGE-AID at 4 weeks]

      Standardized measure of alcohol/drug use

    3. Brief Resilience Scale (BRS) [Change from baseline BRS at 4 weeks]

      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 giving a range of 6-30. Higher score indicates higher resilience.

    4. Defeat Scale [Change from baseline Defeat Scale at 4 weeks]

      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.

    5. Entrapment Scale [Change from baseline Entrapment Scale at 4 weeks]

      This 16-item 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.

    6. Loneliness and Social Distress Scale [Change from baseline Loneliness and Social Distress Scale at 4 weeks]

      Brief measure of thwarted belongingness. Higher ratings indicate greater thwarted belongingness (range 22-154)

    7. Interpersonal Needs Questionnaire [Change from Interpersonal Needs Questionnaire at 4 weeks]

      Brief questionnaire that asks respondents to think about themselves and other people, based on the respondent's current beliefs and experiences.

    8. Suicidal Behavioral Questionnaire-Revised (SBQ-R) [Change from baseline SBQ-R at 4 weeks]

      Self-report questionnaire designed to identify risk factors for suicide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • University of Washington
    • National Institute of Mental Health (NIMH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kate Comtois, Professor, University of Washington
    ClinicalTrials.gov Identifier:
    NCT04536935
    Other Study ID Numbers:
    • STUDY00010842
    • 5P50MH115837-03
    First Posted:
    Sep 3, 2020
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022