Stress, PsychologicalNCT04656626
Brief Mindfulness Based Intervention to Improve Psychological Wellbeing
A study testing brief mindfulness based intervention and Progressive muscle relaxation in people with Stress, Psychological, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- brief mindfulness based intervention and Progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Jul 2020to 5 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COVID19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of KSA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial
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.
- Conditions
- Stress, Psychological
- Being tested
- brief mindfulness based intervention, Progressive muscle relaxation
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief mindfulness based interventionBehavioural
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 relaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID19 Frontline Health Care Providers recieving mindfulness intervention | Experimental | This arm will receive mindfulness audios (randomized and double blinded) Receives: 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) Receives: Behavioral: Progressive muscle relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of anxiety symptom severity
assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety
Measured: 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
Measured: 14 days
Secondary outcomes (2)
mental wellbeing
assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.
Measured: 14days
and functional status
12-Item Short Form survey
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start7 Jul 2020
- Primary completion21 Jul 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani M AlQurni, Imam Abdulrahman Bin Faisal University
- Investigators
- amani al-qurni, BOARD, Principal investigator, IMAM ABDULRHMAN BIN FAISAL UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656626
- Sponsor's protocol ID
- Mindfullness during a pandemic
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32243468Lynn 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 20390691Lau 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 17019673Brooks 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 21275504Carmody 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 at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT04656626
- Acronym / sponsor ID
- Mindfullness during a pandemic
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19 Frontline Health Care Providers recieving mindfulness intervention | Experimental | Behavioral: brief mindfulness based interventionThis arm will receive mindfulness audios (randomized and double blinded) |
| COVID19 Frontline Health Care Providers receiving progressive muscle relaxation | Placebo comparator | Behavioral: Progressive muscle relaxationThis arm will receive progressive muscle relaxation audios (randomized and double blinded) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID19 frontline health care providers namely, physicians, nurses and respiratory therapist at 2 main hospitals in the eastern province of KSA
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief mindfulness based interventionThe 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. | Behavioural | COVID19 Frontline Health Care Providers recieving mindfulness intervention |
| Progressive muscle relaxationControl 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. | Behavioural | COVID19 Frontline Health Care Providers receiving progressive muscle relaxation |
Primary outcome
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
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
2 secondary outcomes
mental wellbeing
Time frame: 14days
and functional status
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Background: PubMed 32243468Alzahrani 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.
- Background: PubMed 20390691Lynn 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.
- Background: PubMed 17019673Lau 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.
- Background: PubMed 21275504Brooks 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.
- Background: PubMed 17899351Carmody 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amani al-qurni, BOARD principal investigator
IMAM ABDULRHMAN BIN FAISAL UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief mindfulness based intervention and Progressive muscle relaxation in people with Stress, Psychological, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of anxiety symptom severity (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656626, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.