Brief Mindfulness Based Intervention to Improve Psychological Wellbeing
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|ClinicalTrials.gov Identifier: NCT04656626|
Recruitment Status : Completed
First Posted : December 7, 2020
Last Update Posted : December 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological||Behavioral: brief mindfulness based intervention Behavioral: Progressive muscle relaxation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
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
|Official Title:||Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial|
|Actual Study Start Date :||July 7, 2020|
|Actual Primary Completion Date :||July 21, 2020|
|Actual Study Completion Date :||September 5, 2020|
Experimental: COVID19 Frontline Health Care Providers recieving mindfulness intervention
This arm will receive mindfulness audios (randomized and double blinded)
Behavioral: brief mindfulness based intervention
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.
Placebo Comparator: COVID19 Frontline Health Care Providers receiving progressive muscle relaxation
This arm will receive progressive muscle relaxation audios (randomized and double blinded)
Behavioral: Progressive muscle relaxation
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.
- reduction of anxiety symptom severity [ Time Frame: 14 days ]assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety
- change in the level of psychological resilience [ Time Frame: 14 days ]assessed using the (Connor-Davidson Resilience Scale (CD-RISC)); score from 0-40, higher scores indicate more resilience
- mental wellbeing [ Time Frame: 14days ]assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.
- and functional status [ Time Frame: 14 days ]12-Item Short Form survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656626
|Imam Abdulrahman Bin Faisal University|
|Dammam, Saudi Arabia|
|Principal Investigator:||amani al-qurni, BOARD||IMAM ABDULRHMAN BIN FAISAL UNIVERSITY|