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CompletedNCT04656626Updated Dec 10, 2020

Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

An interventional study of brief mindfulness based intervention and Progressive muscle relaxation in Stress, Psychological, sponsored by Imam Abdulrahman Bin Faisal University. Completed at 1 site in Saudi Arabia. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.

Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2020, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
22 Years and older
Sex
All
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Study 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

Read the 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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Conditions studied

  • Stress, Psychological

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03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's enrollment of 146 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Imam Abdulrahman Bin Faisal University is the lead sponsor of 88 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
146 participants (actual)

Study arms

  • Experimental
    COVID19 Frontline Health Care Providers recieving mindfulness intervention

    This arm will receive mindfulness audios (randomized and double blinded)

    Behavioral: brief mindfulness based intervention

  • 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

Interventions

  • Behavioralbrief 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.

  • BehavioralProgressive 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.

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What researchers measure

Primary outcomes

  1. reduction of anxiety symptom severity

    assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety

    Time frame: 14 days

  2. 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

    Time frame: 14 days

Secondary outcomes

  1. mental wellbeing

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

    Time frame: 14days

  2. and functional status

    12-Item Short Form survey

    Time frame: 14 days

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Study locations

1 site
  • Imam Abdulrahman Bin Faisal University
    Dammam, Saudi Arabia
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References and documents

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. PubMed 32243468 ↗
  • 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. PubMed 20390691 ↗
  • 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. doi: 10.1002/jclp.20326. PubMed 17019673 ↗
  • 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. PubMed 21275504 ↗
  • 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. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25. PubMed 17899351 ↗

Study documents

  • Protocol and statistical analysis plan · May 5, 2020
  • Informed consent form · May 1, 2020

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04656626
Lead sponsor
Imam Abdulrahman Bin Faisal University
Responsible party
Amani M AlQurni (Assistant Professor - Family Medicine, Imam Abdulrahman Bin Faisal University) — Principal investigator
First posted
Dec 7, 2020
Start date
Jul 7, 2020
Primary completion
Jul 21, 2020
Completion
Sep 5, 2020
Last update
Dec 10, 2020

Study contacts

amani al-qurni, BOARD
principal investigator · IMAM ABDULRHMAN BIN FAISAL UNIVERSITY

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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