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Mobile Mental Health Apps for Suicide Prevention

Primary Purpose

Depression, Anxiety, Emotional Regulation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Mental Health App - 1
Mobile Mental Health App - 2
Mobile Mental Health App - 3
Mobile Mental Health App - 4
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Phase 2: Mobile Mental Health App - 1

Phase 2: Mobile Mental Health App - 2

Phase 2: Mobile Mental Health App - 3

Phase 2: Mobile Mental Health App - 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 22, 2020
Last Updated
October 7, 2022
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04536935
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Emotional Regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
838 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2: Mobile Mental Health App - 1
Arm Type
Active Comparator
Arm Description
Participants randomized to a free mobile mental health application that focuses on meditation.
Arm Title
Phase 2: Mobile Mental Health App - 2
Arm Type
Active Comparator
Arm Description
Participants randomized to a free mobile mental health application that assists with coping with COVID-19.
Arm Title
Phase 2: Mobile Mental Health App - 3
Arm Type
Active Comparator
Arm Description
Participants randomized to a free mobile mental health application that focuses on positive psychology.
Arm Title
Phase 2: Mobile Mental Health App - 4
Arm Type
Active Comparator
Arm Description
Participants randomized to a free mobile application that addresses mental health issues through mood tracking.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Mental Health App - 1
Other Intervention Name(s)
Calm
Intervention Description
Free mobile mental health application that focuses on meditation
Intervention Type
Behavioral
Intervention Name(s)
Mobile Mental Health App - 2
Other Intervention Name(s)
COVID Coach
Intervention Description
Free mobile mental health application that assists with coping with COVID-19
Intervention Type
Behavioral
Intervention Name(s)
Mobile Mental Health App - 3
Other Intervention Name(s)
7 Cups of Tea
Intervention Description
Free mobile mental health application that focuses on positive psychology.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Mental Health App - 4
Other Intervention Name(s)
Beautiful Mood
Intervention Description
Free mobile application that addresses mental health issues through mood tracking
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.
Title
Generalized Anxiety Disorder (7-Item) Scale (GAD-7)
Description
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.
Time Frame
GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks.
Title
Brief Difficulties With Emotional Regulation Scale (DERS)
Description
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.
Time Frame
DERS at RCT baseline and RCT follow-up; duration of four weeks.
Title
Suicidal Behavioral Questionnaire-Revised (SBQ-R)
Description
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.
Time Frame
SBQ-R RCT baseline and RCT follow-up; duration of four weeks.
Secondary Outcome Measure Information:
Title
Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Title
Intervention Appropriateness Measure (IAM)
Description
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.
Time Frame
Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Title
Intervention Usability Scale (IUS)
Description
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.
Time Frame
Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.
Title
Feasibility of Intervention Measure (FIM)
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
PARS EQ-5D
Description
Standardized measure of health status with a total score range of 0 - 1. Maximum score of one indicates the best health state.
Time Frame
PARS EQ-5D at RCT baseline and RCT follow-up; duration of 4 weeks.
Title
CAGE-AID
Description
Standardized measure of alcohol/drug use with a total score range of 0 - 4. Higher scores indicate higher risk for substance use.
Time Frame
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.
Title
Brief Resilience Scale (BRS)
Description
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.
Time Frame
Participants will complete the BRS at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.
Title
Defeat Scale
Description
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.
Time Frame
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.
Title
Entrapment Scale
Description
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.
Time Frame
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.
Title
Interpersonal Needs Questionnaire
Description
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).
Time Frame
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.
Title
Loneliness and Social Distress Scale
Description
No data displayed because outcome measure data was not collected therefore zero total participants analyzed.
Time Frame
Loneliness and Social Distress Scale at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36191176
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.
Results Reference
derived
PubMed Identifier
35617246
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.
Results Reference
derived

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Mobile Mental Health Apps for Suicide Prevention

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