Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

Study Overview
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Brief Summary
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our aim is to evaluate the effectiveness of virtual brief mindfulness based interventions on psychological wellbeing, resiliency, and anxiety of frontline HCP to cope for (COVID19) stressors

Detailed Description
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Our specific objectives are: To measure frontline HCP's level of anxiety, resilience, and how mindfulness based interventions affect anxiety and psychological resilience of HCP.

Official Title
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Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: brief mindfulness based intervention
* Behavioral: Progressive muscle relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of KSA Exclusion Criteria: History of psychotic disorder, Substance abuse or dependence within the last 6 months Current severe neurotic disorder, severe depression or severe anxiety. Concurrent psychotherapy. Significant personality disorder

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID19 Frontline Health Care Providers recieving mindfulness intervention<br>This arm will receive mindfulness audios (randomized and double blinded) | Behavioral: brief mindfulness based intervention<br>* The 20 minute daily mindfulness sessions for 2 weeks consist of the following guided meditation practices: 1. Bring your attention to a primary object of focus 2. Maintain a moment-moment awareness 3. When your mind naturally drifts into thinking (mind wandering); just notice you are thinking, and then bring your attention back to your object of focus 4. When a strong sensation arises, again, notice the sensation or emotion and return to your breath. 5. As you gain confidence, you may practice maintaining this focus while observing thoughts flowing through your mind or sensations in your body while showing no concern for the content 6. You may even label your thoughts 7. Thank yourself for your efforts and for taking this time.<br>|
| Placebo Comparator: COVID19 Frontline Health Care Providers receiving progressive muscle relaxation<br>This arm will receive progressive muscle relaxation audios (randomized and double blinded) | Behavioral: Progressive muscle relaxation<br>* Control group: Control group will be given an mp3 audio recording of a 20-minutes of progressive muscle relaxation will be sent directly as SMS messages and emails to be heard by the participants through their personal device of their choice, such as a smart phone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of anxiety symptom severity | assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety | 14 days | 
| change in the level of psychological resilience | assessed using the (Connor-Davidson Resilience Scale (CD-RISC)); score from 0-40, higher scores indicate more resilience | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mental wellbeing | assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better. | 14days | 
| and functional status | 12-Item Short Form survey | 14 days |