NCT04536935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
838

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

August 22, 2020

Results QC Date

July 18, 2022

Last Update Submit

October 7, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (4)

  • Acceptability of Intervention Measure (AIM)

    Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.

  • Intervention Appropriateness Measure (IAM)

    Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.

  • Intervention Usability Scale (IUS)

    Participants will complete this measure at RCT Follow-Up; after 4 weeks of using the mobile mental health app to which they are randomized.

  • Feasibility of Intervention Measure (FIM)

    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 (7)

  • PARS EQ-5D

    PARS EQ-5D at RCT baseline and RCT follow-up; duration of 4 weeks.

  • CAGE-AID

    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.

  • Brief Resilience Scale (BRS)

    Participants will complete the BRS at RCT follow-up; after 4 weeks of using the mobile mental health app to which they are randomized.

  • +4 more other outcomes

Study Arms (4)

Phase 2: Mobile Mental Health App - 1

ACTIVE COMPARATOR

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

Behavioral: Mobile Mental Health App - 1

Phase 2: Mobile Mental Health App - 2

ACTIVE COMPARATOR

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

Behavioral: Mobile Mental Health App - 2

Phase 2: Mobile Mental Health App - 3

ACTIVE COMPARATOR

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

Behavioral: Mobile Mental Health App - 3

Phase 2: Mobile Mental Health App - 4

ACTIVE COMPARATOR

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

Behavioral: Mobile Mental Health App - 4

Interventions

Free mobile mental health application that focuses on meditation

Also known as: Calm
Phase 2: Mobile Mental Health App - 1

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

Also known as: COVID Coach
Phase 2: Mobile Mental Health App - 2

Free mobile mental health application that focuses on positive psychology.

Also known as: 7 Cups of Tea
Phase 2: Mobile Mental Health App - 3

Free mobile application that addresses mental health issues through mood tracking

Also known as: Beautiful Mood
Phase 2: Mobile Mental Health App - 4

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase 1
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

DepressionAnxiety DisordersEmotional Regulation

Interventions

Calmodulin

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

Intracellular Calcium-Sensing ProteinsIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsCalcium-Binding ProteinsCarrier ProteinsProteins

Results Point of Contact

Title
Morgan Johnson
Organization
University of Washington

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2020

First Posted

September 3, 2020

Study Start

November 30, 2020

Primary Completion

June 20, 2021

Study Completion

June 20, 2021

Last Updated

October 20, 2022

Results First Posted

October 20, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations