Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- reduction of anxiety symptom severity
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- 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
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
COVID19 Frontline Health Care Providers recieving mindfulness intervention
This arm will receive mindfulness audios (randomized and double blinded)
Intervention: brief mindfulness based intervention (Behavioral)
COVID19 Frontline Health Care Providers receiving progressive muscle relaxation
This arm will receive progressive muscle relaxation audios (randomized and double blinded)
Intervention: Progressive muscle relaxation (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- and functional status(14 days)
- mental wellbeing(14days)
Investigators
Amani M AlQurni
Assistant Professor - Family Medicine
Imam Abdulrahman Bin Faisal University