Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

Stress, Psychological Clinical Trial

Official title:

Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656626
• Other study ID #: Mindfullness during a pandemic
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: September 5, 2020

Study information

• Verified date: December 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 5, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of anxiety symptom severity	assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety	14 days
Primary	change in the level of psychological resilience	assessed using the (Connor-Davidson Resilience Scale (CD-RISC)); score from 0-40, higher scores indicate more resilience	14 days
Secondary	mental wellbeing	assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.	14days
Secondary	and functional status	12-Item Short Form survey	14 days