Psychological StressNCT05415280
Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction
A study testing Mindfulness Based stress reduction in people with Psychological Stress, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 19 to 35 years
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Mindfulness Based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 1 Dec 2022
- 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 19 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participants fulfil the age criteria, students from public and private universities, and provided signed informed consent.
Who cannot join
- Participant suffering from chronic physical or psychological disorder. In addition participant who experience death of loved ones during COVID-19 pandemic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction During Pandemic: A Randomized Control Trails
The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic.
Read the detailed description
In the current study the data was collected from the young adults (age range 19-35 years). The high scorer from the sample selected from the participants in both control and experimental groups. furthermore, the mindfulness based stress reduction intervention was given to the experimental group. The mindfulness based stress reduction intervention comprised eight weeks period. After the provision of intervention the data for the second phase would be collected.
- Conditions
- Psychological Stress
- Being tested
- Mindfulness Based stress reduction
- Keywords
- psychological stress mobile phone addiction
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based stress reductionBehavioural
The aim of the psychological intervention to reduce the mental health problems of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based stress reduction | Experimental | mindfulness based stress reduction intervention was used to treat psychological and addiction problems of the individuals Receives: Behavioral: Mindfulness Based stress reduction |
| Relaxation Exercise | Other | the control group was provided with the relaxation technique. Receives: Behavioral: Mindfulness Based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 related Stress
COVID-19 related stress scale(<5 minimum, >72 Maximum)
Measured: 35 minutes
anxiety and depression
hospitalized anxiety and depression scale (<7 minimum, >21 Maximum)
Measured: 15 minutes
Secondary outcomes (1)
mobile phone addiction
smartphone addiction scale (33 minimum, 198maximum)
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zia-un-nisa, Fatima Jinnah Women University
- Investigators
- zia-un Nisa, Principal investigator, assisstant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415280
- Sponsor's protocol ID
- MBSR
- Status last verified
- Jun 2022
- First submitted
- 24 Feb 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigator has not plan to share data without taking permission from the study participants.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness Based Intervention on the COVID-19 Related Distress and Mobile Addiction During Pandemic: A Randomized Control Trails
- ClinicalTrials.gov ID
- NCT05415280
- Acronym / sponsor ID
- MBSR
- Conditions
- Psychological Stress
- Keywords
- psychological stress mobile phone addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 13 Jun 2022 (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.
The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic.
Detailed description
In the current study the data was collected from the young adults (age range 19-35 years). The high scorer from the sample selected from the participants in both control and experimental groups. furthermore, the mindfulness based stress reduction intervention was given to the experimental group. The mindfulness based stress reduction intervention comprised eight weeks period. After the provision of intervention the data for the second phase would be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based stress reduction | Experimental | Behavioral: Mindfulness Based stress reductionmindfulness based stress reduction intervention was used to treat psychological and addiction problems of the individuals |
| Relaxation Exercise | Other | Behavioral: Mindfulness Based stress reductionthe control group was provided with the relaxation technique. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The participants fulfil the age criteria, students from public and private universities, and provided signed informed consent.
Key exclusion criteria (1 listed)
- Participant suffering from chronic physical or psychological disorder. In addition participant who experience death of loved ones during COVID-19 pandemic.
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 |
|---|---|---|
| Mindfulness Based stress reductionThe aim of the psychological intervention to reduce the mental health problems of the participants. | Behavioural | Mindfulness based stress reduction, Relaxation Exercise |
Primary outcome
COVID-19 related Stress
Time frame: 35 minutes
COVID-19 related stress scale(<5 minimum, >72 Maximum)
anxiety and depression
Time frame: 15 minutes
hospitalized anxiety and depression scale (<7 minimum, >21 Maximum)
1 secondary outcome
mobile phone addiction
Time frame: 35 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No. The investigator has not plan to share data without taking permission from the study participants.
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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.
zia-un Nisa principal investigator
assisstant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based stress reduction in people with Psychological Stress, run by Fatima Jinnah Women University at 1 site in Pakistan.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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 Pakistan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zia-un nisa (03335248819, ziaunnisa95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 related Stress (time frame: 35 minutes). 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?
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 14 Jun 2022.