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Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

Sponsor
Imam Abdulrahman Bin Faisal University (Other)
Overall Status
Completed
CT.gov ID
NCT04656626
Collaborator
(none)
146
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
74.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: brief mindfulness based intervention
  • Behavioral: Progressive muscle relaxation
 N/A

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
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 :
Jul 7, 2020
Actual Primary Completion Date :
Jul 21, 2020
Actual Study Completion Date :
Sep 5, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. reduction of anxiety symptom severity [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 [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 [14days]

    assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.

  2. and functional status [14 days]

    12-Item Short Form survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
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:

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imam Abdulrahman Bin Faisal University Dammam Saudi Arabia

Sponsors and Collaborators

  • Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: amani al-qurni, BOARD, IMAM ABDULRHMAN BIN FAISAL UNIVERSITY

Study Documents (Full-Text)

More Information

Publications

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:
Dec 7, 2020
Last Update Posted:
Dec 10, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stress, Psychological

Study Results

No Results Posted as of Dec 10, 2020