NCT04656626

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

14 days

First QC Date

December 4, 2020

Last Update Submit

December 8, 2020

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • mental wellbeing

    14days

  • and functional status

    14 days

Study Arms (2)

COVID19 Frontline Health Care Providers recieving mindfulness intervention

EXPERIMENTAL

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

Behavioral: brief mindfulness based intervention

COVID19 Frontline Health Care Providers receiving progressive muscle relaxation

PLACEBO COMPARATOR

This arm will receive progressive muscle relaxation audios (randomized and double blinded)

Behavioral: Progressive muscle relaxation

Interventions

brief mindfulness based interventionBEHAVIORAL

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.

COVID19 Frontline Health Care Providers recieving mindfulness intervention
Progressive muscle relaxationBEHAVIORAL

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.

COVID19 Frontline Health Care Providers receiving progressive muscle relaxation

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COVID19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of KSA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Saudi Arabia

Location

Related 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.

    PMID: 32243468BACKGROUND

  • 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.

    PMID: 20390691BACKGROUND

  • 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.

    PMID: 17019673BACKGROUND

  • 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.

    PMID: 21275504BACKGROUND

  • 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.

    PMID: 17899351BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • amani al-qurni, BOARD

    IMAM ABDULRHMAN BIN FAISAL UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Family Medicine

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 7, 2020

Study Start

July 7, 2020

Primary Completion

July 21, 2020

Study Completion

September 5, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations

SA(1)