Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

• ClinicalTrials.gov Identifier: NCT04656626
• Recruitment Status: Completed
• First Posted: December 7, 2020
• Last Update Posted: December 10, 2020
• Sponsor: Imam Abdulrahman Bin Faisal University
• Information provided by (Responsible Party): Amani M AlQurni, Imam Abdulrahman Bin Faisal University

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
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.

Study Design

• 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

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 [ 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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Saudi Arabia

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)

Documents provided by Amani M AlQurni, Imam Abdulrahman Bin Faisal University:

Study Protocol and Statistical Analysis Plan  [PDF] May 5, 2020

Informed Consent Form  [PDF] May 1, 2020

More Information

Publications:

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.

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.

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.

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. Review.

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. Epub 2007 Sep 25.

• 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
• Last Update Posted: December 10, 2020
• Last Verified: December 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; Behavioral Symptoms