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Completed

NCT Number: NCT04656626

Brief Mindfulness Based Intervention to Improve Psychological Wellbeing

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

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imam Abdulrahman Bin Faisal University

Dammam, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Mindfulness Based Intervention

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2020
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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