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Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
brief mindfulness based intervention
Progressive muscle relaxation
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress, Psychological

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Imam Abdulrahman Bin Faisal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVID19 Frontline Health Care Providers recieving mindfulness intervention

COVID19 Frontline Health Care Providers receiving progressive muscle relaxation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

mental wellbeing
assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.
and functional status
12-Item Short Form survey

Full Information

First Posted
December 4, 2020
Last Updated
December 8, 2020
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT04656626
Brief Title
Brief Mindfulness Based Intervention to Improve Psychological Wellbeing
Official Title
Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
July 21, 2020 (Actual)
Study Completion Date
September 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID19 Frontline Health Care Providers recieving mindfulness intervention
Arm Type
Experimental
Arm Description
This arm will receive mindfulness audios (randomized and double blinded)
Arm Title
COVID19 Frontline Health Care Providers receiving progressive muscle relaxation
Arm Type
Placebo Comparator
Arm Description
This arm will receive progressive muscle relaxation audios (randomized and double blinded)
Intervention Type
Behavioral
Intervention Name(s)
brief mindfulness based intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive muscle relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
reduction of anxiety symptom severity
Description
assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety
Time Frame
14 days
Title
change in the level of psychological resilience
Description
assessed using the (Connor-Davidson Resilience Scale (CD-RISC)); score from 0-40, higher scores indicate more resilience
Time Frame
14 days
Secondary Outcome Measure Information:
Title
mental wellbeing
Description
assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.
Time Frame
14days
Title
and functional status
Description
12-Item Short Form survey
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amani al-qurni, BOARD
Organizational Affiliation
IMAM ABDULRHMAN BIN FAISAL UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32243468
Citation
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.
Results Reference
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PubMed Identifier
20390691
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.
Results Reference
background
PubMed Identifier
17019673
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. doi: 10.1002/jclp.20326.
Results Reference
background
PubMed Identifier
21275504
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.
Results Reference
background
PubMed Identifier
17899351
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. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.
Results Reference
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Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

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