Psychological DistressNCT06263335
MBI for Psychological Distress, SI and NSSI Among Young Adults
A study testing Mindfulness Based Stress Reduction Intervention in people with Psychological Distress and Suicidal Ideation, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Suicidal Ideation, Non-Suicidal Self Injury
- What is being tested?
- Mindfulness Based Stress Reduction Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2022to 28 May 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 18-24, of any gender, who consented to participate and could comprehend English (the language of the questionnaires).
- Selected respondents from the initial survey were included based on specific criteria:
- Willingness to continue participation.
- Unmarried status.
- Pursuing education (Bachelors, Masters, or Ph.D.) , Pakistan.
- Non-hosteller and unemployed.
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- Residing with both parents.
- Affirmative response to screener questions about suicidal ideation (SI) and non-suicidal self-injury (NSSI).
- High scores on psychological distress and SI scales.
Who cannot join
- Participants failing to meet inclusion criteria or falling under the following categories were excluded:
- Non-students.
- History of present or past psychiatric illness, with recent medication or treatment within the past year.
- Presence of debilitating physical diseases or disabilities. Involvement in or history of substance use.
- Long-term medication for any condition, as these factors could impact study results.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima Jinnah Women University
Rawalpindi, Punjab Province, 46000
About this study
Official title: Impact of Mindfulness Based Therapeutic Intervention on Psychological Distress, Suicidal Ideation and Non-Suicidal Self Injury Among Young Adults: A Randomized Controlled Trial
Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups.
Read the detailed description
Study assessment measures:
- Informed consent form
- Demographic questionnaire
- Screener questions form
- Assessment instruments:
- Depression Anxiety and Stress Scale (DASS-21)
- Suicide Ideation Scale (SIS)
- Alexian Brothers Urge to Self Injure Scale (ABUSI)
- Mindfulness Attention Awareness Scale
- Being tested
- Mindfulness Based Stress Reduction Intervention
- Keywords
- Mindfulness Based Intervention, Psychological Distress, Suicidal Ideation, Non-Suicidal Self Injury
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction InterventionOther
During an eight-week intervention period, clients were to engage in mindfulness practices lasting between 45 minutes to an hour each session. The intervention would incorporate various components of the Mindfulness-Based Stress Reduction (MBSR) program, including mindfulness of the present moment, body scans, mindful eating, walking meditation, yoga exercises, and discussions on applying mindfulness to everyday experiences and stress management. Sessions would typically range from 30 to 90 minutes per week, with an additional full-day retreat session towards the end of the program. In addition to mindfulness practice, participants were to receive teachings on stress management and its application to interpersonal and daily life situations.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group (Receiving Mindfulness Based Intervention) | Experimental | after the young adults have been randomized into interventional and control groups based on high levels of psychological distress, SI and NSSI, n=30 participants from this group would receive the mindfulness based intervention. Receives: Other: Mindfulness Based Stress Reduction Intervention |
| Control Group (No Intervention) | No intervention | A wait list control group of n=30 randomized participants from the initial cohort would be in this group and receive no intervention, until the trial is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
This refers to the overall level of emotional suffering or discomfort experienced by individuals, often encompassing symptoms of depression, anxiety, and stress. In this study, psychological distress serves as a primary outcome measure because it is a key variable being assessed in relation to the intervention's efficacy.
Measured: 8-12 weeks
Suicidal Ideation
Suicidal ideation involves thoughts or ideas about engaging in behaviors intended to end one's life. As a primary outcome measure, assessing suicidal ideation is crucial in understanding the impact of the intervention on the participants' mental health and risk of self-harm.
Measured: 8-12 weeks
Non-Suicidal Self-Injury (NSSI)
NSSI refers to deliberate, self-inflicted harm to one's body without suicidal intent, such as cutting or burning oneself. It is an essential primary outcome measure in this study because it directly relates to the intervention's effectiveness in reducing self-harming behaviors among participants.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start28 Feb 2022
- Primary completion28 May 2022
- Study completion28 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia Sohail, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263335
- Sponsor's protocol ID
- Fatima Jinnah Women University
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within the ethical considerations, results of research would be shared via research publications.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness Based Therapeutic Intervention on Psychological Distress, Suicidal Ideation and Non-Suicidal Self Injury Among Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06263335
- Acronym / sponsor ID
- Fatima Jinnah Women University
- Keywords
- Mindfulness Based Intervention, Psychological Distress, Suicidal Ideation, Non-Suicidal Self Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 16 Feb 2024 (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.
Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups.
Detailed description
Study assessment measures:
- Informed consent form
- Demographic questionnaire
- Screener questions form
- Assessment instruments:
- Depression Anxiety and Stress Scale (DASS-21)
- Suicide Ideation Scale (SIS)
- Alexian Brothers Urge to Self Injure Scale (ABUSI)
- Mindfulness Attention Awareness Scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group (Receiving Mindfulness Based Intervention) | Experimental | Other: Mindfulness Based Stress Reduction Interventionafter the young adults have been randomized into interventional and control groups based on high levels of psychological distress, SI and NSSI, n=30 participants from this group would receive the mindfulness based intervention. |
| Control Group (No Intervention) | No intervention | –A wait list control group of n=30 randomized participants from the initial cohort would be in this group and receive no intervention, until the trial is completed. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants aged 18-24, of any gender, who consented to participate and could comprehend English (the language of the questionnaires).
- Selected respondents from the initial survey were included based on specific criteria:
- Willingness to continue participation.
- Unmarried status.
- Pursuing education (Bachelors, Masters, or Ph.D.) , Pakistan.
Key exclusion criteria (5 listed)
- Participants failing to meet inclusion criteria or falling under the following categories were excluded:
- Non-students.
- History of present or past psychiatric illness, with recent medication or treatment within the past year.
- Presence of debilitating physical diseases or disabilities. Involvement in or history of substance use.
- Long-term medication for any condition, as these factors could impact study results.
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 Reduction InterventionDuring an eight-week intervention period, clients were to engage in mindfulness practices lasting between 45 minutes to an hour each session. The intervention would incorporate various components of the Mindfulness-Based Stress Reduction (MBSR) program, including mindfulness of the present moment, body scans, mindful eating, walking meditation, yoga exercises, and discussions on applying mindfulness to everyday experiences and stress management. Sessions would typically range from 30 to 90 minutes per week, with an additional full-day retreat session towards the end of the program. In addition to mindfulness practice, participants were to receive teachings on stress management and its application to interpersonal and daily life situations. | Other | Interventional Group (Receiving Mindfulness Based Intervention) |
Primary outcome
Psychological Distress
Time frame: 8-12 weeks
This refers to the overall level of emotional suffering or discomfort experienced by individuals, often encompassing symptoms of depression, anxiety, and stress. In this study, psychological distress serves as a primary outcome measure because it is a key variable being assessed in relation to the intervention's efficacy.
Suicidal Ideation
Time frame: 8-12 weeks
Suicidal ideation involves thoughts or ideas about engaging in behaviors intended to end one's life. As a primary outcome measure, assessing suicidal ideation is crucial in understanding the impact of the intervention on the participants' mental health and risk of self-harm.
Non-Suicidal Self-Injury (NSSI)
Time frame: 8-12 weeks
NSSI refers to deliberate, self-inflicted harm to one's body without suicidal intent, such as cutting or burning oneself. It is an essential primary outcome measure in this study because it directly relates to the intervention's effectiveness in reducing self-harming behaviors among participants.
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 16 Feb 2024.
- Individual participant dataSharing planned: Yes. Within the ethical considerations, results of research would be shared via research publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intervention in people with Psychological Distress and Suicidal Ideation, 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 9 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 16 Feb 2024. 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?
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?
Psychological Distress (time frame: 8-12 weeks). The study lists 3 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 16 Feb 2024.