CovidResearchTrials by Shray Alag


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Healthy Minds Program Foundations TrainingWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D013315 Stress, Psychological NIH 0.21

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There is one clinical trial.

Clinical Trials


1 COVID-19 and the Healthy Minds Program for Educators

This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted. Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted. The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.

NCT04426318 Anxiety Depression Psychological Stress Psychological Distress Well-being Behavioral: Healthy Minds Program Foundations Training
MeSH:Stress, Psychological

Primary Outcomes

Description: Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.

Measure: Change from baseline on an aggregate measure of Psychological distress that averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Secondary Outcomes

Description: A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.

Measure: Change from baseline on the Five Facet Mindfulness Questionnaire Act with Awareness subscale

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.

Measure: Change from baseline on the Drexel Defusion Scale (DDS)

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.

Measure: Change from baseline on the Meaning in Life Questionnaire

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.

Measure: Change from baseline on the NIH Toolbox Loneliness scale

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. The perceived coronavirus threat, coronavirus impacts questionnaire, and coronavirus experiences subscales will be summed. The total possible range in scores is 7 - 112 with higher scores representing greater perceived threat.

Measure: Change from baseline on the Conway COVID Questionnaire

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.

Measure: Change from baseline on the Self-Compassion Scale Short Form

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.

Measure: Change from baseline on the Perseverative Thought Questionnaire

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: Well-being with be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.

Measure: Change from baseline on the World Health Organization 5-item (WHO-5) well-being scale

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for both prosocial construal and bias range from 1 to 7, with higher scores representing greater prosocial construal and bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).

Measure: Change from baseline on the Neutral Face Rating task

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).

Measure: Change from baseline on the Growth Mindset Scale for Well-Being

Time: baseline, 4 weeks (post intervention)

Other Outcomes

Description: 4-tems following each app-based practice for treatment participants that ask about perceive quality of the practice, (1 poor, 9 very good), and mood (1 poor, 5 good).

Measure: Slope across time on Practice quality and mood items

Time: Every other day when participant completes a practice (up to 4 weeks)

Description: A measure of working alliance in a digital environment that will be averaged across all items for a score range from 1 to 7, with higher scores reflecting higher levels of alliance.

Measure: Digital working alliance

Time: After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only


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