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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID19 Frontline Health Care Providers recieving mindfulness intervention | Experimental | This arm will receive mindfulness audios (randomized and double blinded) |
|
| COVID19 Frontline Health Care Providers receiving progressive muscle relaxation | Placebo Comparator | This arm will receive progressive muscle relaxation audios (randomized and double blinded) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brief mindfulness based intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| amani al-qurni, BOARD | IMAM ABDULRHMAN BIN FAISAL UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Abdulrahman Bin Faisal University | Dammam | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32243468 | Background | Alzahrani AM, Hakami A, AlHadi A, Batais MA, Alrasheed AA, Almigbal TH. The interplay between mindfulness, depression, stress and academic performance in medical students: A Saudi perspective. PLoS One. 2020 Apr 3;15(4):e0231088. doi: 10.1371/journal.pone.0231088. eCollection 2020. | |
| 20390691 | Background | Lynn SJ, Barnes S, Deming A, Accardi M. Hypnosis, rumination, and depression: catalyzing attention and mindfulness-based treatments. Int J Clin Exp Hypn. 2010 Apr;58(2):202-21. doi: 10.1080/00207140903523244. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2020 | Dec 5, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2020 | Dec 6, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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masking/ blindness was programmed in the system/website that was developed for this study; the participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.
the system/ website For the sack of this study a new system was developed to be used for data collection. The system was designed as an electronic questioner with audio clips that is sent automatically to the participants' email and phones, where each participant receives their own special link.
the participants after responding to the pre intervention link will be automatically randomized by the system/website to intervention or control group.
the whole data collection and intervention process is automatic, virtual and blinded
|
| Progressive muscle relaxation | Behavioral | 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. |
|
| 14 days |
| 17019673 | Background | Lau MA, Bishop SR, Segal ZV, Buis T, Anderson ND, Carlson L, Shapiro S, Carmody J, Abbey S, Devins G. The Toronto Mindfulness Scale: development and validation. J Clin Psychol. 2006 Dec;62(12):1445-67. doi: 10.1002/jclp.20326. |
| 21275504 | Background | Brooks SK, Gerada C, Chalder T. Review of literature on the mental health of doctors: are specialist services needed? J Ment Health. 2011 Apr;20(2):146-56. doi: 10.3109/09638237.2010.541300. Epub 2011 Jan 28. |
| 17899351 | Background | Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008 Feb;31(1):23-33. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25. |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |