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DepressionNCT04536935

Mobile Mental Health Apps for Suicide Prevention

A study testing Mobile Mental Health App - 1, Mobile Mental Health App - 2 and Mobile Mental Health App - 3 in people with Depression and Anxiety, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Depression, Anxiety, Emotional Regulation
What is being tested?
Mobile Mental Health App - 1, Mobile Mental Health App - 2 and Mobile Mental Health App - 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
838 participants
Where
1 siteUnited States
Study dates
30 Nov 2020to 20 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Mobile Mental Health App - 1, Mobile Mental Health App - 2, Mobile Mental Health App - 3, Mobile Mental Health App - 4
Medical subject headings
Depression, Anxiety Disorders, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile Mental Health App - 1Behavioural

    Also called Calm

    Free mobile mental health application that focuses on meditation

  • Mobile Mental Health App - 2Behavioural

    Also called COVID Coach

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

  • Mobile Mental Health App - 3Behavioural

    Also called 7 Cups of Tea

    Free mobile mental health application that focuses on positive psychology.

  • Mobile Mental Health App - 4Behavioural

    Also called Beautiful Mood

    Free mobile application that addresses mental health issues through mood tracking

Study groups in NCT04536935
Study groupRoleWhat they receive
Phase 2: Mobile Mental Health App - 1Active comparatorParticipants randomized to a free mobile mental health application that focuses on meditation.
Receives: Behavioral: Mobile Mental Health App - 1
Phase 2: Mobile Mental Health App - 2Active comparatorParticipants randomized to a free mobile mental health application that assists with coping with COVID-19.
Receives: Behavioral: Mobile Mental Health App - 2
Phase 2: Mobile Mental Health App - 3Active comparatorParticipants randomized to a free mobile mental health application that focuses on positive psychology.
Receives: Behavioral: Mobile Mental Health App - 3
Phase 2: Mobile Mental Health App - 4Active comparatorParticipants randomized to a free mobile application that addresses mental health issues through mood tracking.
Receives: Behavioral: Mobile Mental Health App - 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.

  2. 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.

    Measured: GAD-7 at RCT baseline and RCT follow-up; duration of 4 weeks.

  3. 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.

    Measured: DERS at RCT baseline and RCT follow-up; duration of four weeks.

  4. 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.

    Measured: SBQ-R RCT baseline and RCT follow-up; duration of four weeks.

Secondary outcomes (4)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2020
  2. Study start30 Nov 2020
  3. Primary completion20 Jun 2021
  4. Study completion20 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
838 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536935
Sponsor's protocol ID
STUDY00010842
Other IDs
5P50MH115837-03
Status last verified
Oct 2022
First submitted
22 Aug 2020
Last updated
20 Oct 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36191176

  • 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.

    PubMed 35617246

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Mental Health App - 1, Mobile Mental Health App - 2 and Mobile Mental Health App - 3 in people with Depression and Anxiety, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire (PHQ-9) (time frame: PHQ-9 at RCT baseline and RCT follow-up; duration of 4 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536935, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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