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Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656626
Recruitment Status : Completed
First Posted : December 7, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Amani M AlQurni, Imam Abdulrahman Bin Faisal University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: brief mindfulness based intervention Behavioral: Progressive muscle relaxation Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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

Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Stress

Arm Intervention/treatment
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:

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.





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. mental wellbeing [ Time Frame: 14days ]
    assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.

  2. and functional status [ Time Frame: 14 days ]
    12-Item Short Form survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. History of psychotic disorder,
  2. Substance abuse or dependence within the last 6 months
  3. Current severe neurotic disorder, severe depression or severe anxiety.
  4. Concurrent psychotherapy.
  5. Significant personality disorder

Information from the National Library of Medicine

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


Locations
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Saudi Arabia
Imam Abdulrahman Bin Faisal University
Dammam, Saudi Arabia
Sponsors and Collaborators
Imam Abdulrahman Bin Faisal University
Investigators
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Principal Investigator: amani al-qurni, BOARD IMAM ABDULRHMAN BIN FAISAL UNIVERSITY
  Study Documents (Full-Text)

Documents provided by Amani M AlQurni, Imam Abdulrahman Bin Faisal University:
Informed Consent Form  [PDF] May 1, 2020

Publications:
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Responsible Party: Amani M AlQurni, Assistant Professor - Family Medicine, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier: NCT04656626    
Other Study ID Numbers: Mindfullness during a pandemic
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms