Intervention StudyMBSRNCT05653739
Mindfulness Based Stress Reduction Intervention
A study testing Mindfulness Based Stress Reduction Intervention in people with Intervention Study, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
The aim of the current study is to find out the impact of Mindfulness based stress reduction intervention on psychosocial factors associated with distress tolerance and quality of life among youth . The study is conducted on the youth age ranging from 15-24 years from districts Mardan and Nowshera of KP. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Intervention Study
- What is being tested?
- Mindfulness Based Stress Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 31 Aug 2023
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The participants studying in different public and private sector higher education institutes of Mardan and Nowshera districts of KP.
- Participants who volunteer to participate were included.
- Participants with High psychological distress, and Vicarious Trauma.
- Participants with low distress tolerance and low quality of life.
Who cannot join
- Participants below 15 years or above 24 years i.e., the age range of youth (as recommended by WHO) will be excluded.
- Participants with any significant reported medical disease were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current study is to find out the impact of Mindfulness based stress reduction intervention on psychosocial factors associated with distress tolerance and quality of life among youth . The study is conducted on the youth age ranging from 15-24 years from districts Mardan and Nowshera of KP. Standardized tools are used to screen highly vulnerable cohort for further intervention. Eligible participants who scored higher on psychological distress, vicarious traumatization, and low on distress tolerance and quality of life and show their consent were recruited for the Intervention Phase. Participants were assigned randomly to experimental and control groups in intervention phase. Participants in the experimental group were given Mindfulness Based Stress Intervention (MBSR) training in the settings conducive for research.
- Conditions
- Intervention Study
- Being tested
- Mindfulness Based Stress Reduction Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction InterventionBehavioural
MBSR is Mindfulness based intervention designed by Kabat-Zinn (1990) in order to deal with the stress and other psychological issues among individuals. This has been very effective intervention across different cultures . In this 8 week intervention participants will be given some home tasks to practice for at least 40 minutes a day.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Intervention Group | Experimental | Mindfulness Based Stress Reduction Intervention , The training consists of eight weekly group sessions with the duration of approximately 2-2.5 hours with a trained instructor. Further participants were given daily audio-guided home practice (approximately 45 min/day), and a day-long mindfulness retreat (occurring during week sixth of the 8-week program) Receives: Behavioral: Mindfulness Based Stress Reduction Intervention |
| Control Group | No intervention | Participants in the control group were not given any intervention in order to compare with the experimental group. At the end of the study participants in this group were also offered relaxation trainings in order to deal with the psychological distress, quality of life and distress tolerance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Psychological distress.
Psychological distress will be measured through Depression Anxiety and Stress Scale (DASS). After giving intervention to the participants it is expected that the participants will score low on the scale as low score is the indication of low level of psychological distress on DASS. Score above 32 will be considered as high level of psychological distress while score below 32 will be considered as indication of low level of psychological distress
Measured: Psychological distress will be measured before giving the intervention and at 8 weeks of intervention again the scale will be administered to measure psychological distress in order to check changes.
Changes in Vicarious Trauma
Vicarious Trauma will be measured through Secondary Stress Trauma Questionnaire. Individuals scoring above 44 on the scale is the indication of high level of secondary traumatic symptoms.
Measured: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on STQ.
Change in Distress Tolerance
Distress Tolerance will be measured through Distress Tolerance Scale (DTS).Low scores on the scale is the indication of higher level of distress tolerance. So score above 34 will be selected for participants to be recruited for study.
Measured: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on DTS i.e., their distress tolerance will be improved.
change in Quality of Life
Quality of life will be measured through The World Health Organization Quality of Life Scale (WHOQOL-BREF). High scores on the scale is the indication of high level of quality of life. Individuals scoring above 62 on the scale will be considered as scoring high on QOL for the current study. After participants are exposed to the intervention they will score higher on WHOQOL-BREF which means high quality of life.
Measured: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score high on WHOQOL-BREF.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start25 Feb 2023
- Primary completion30 May 2023
- Study completion31 Aug 2023
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 Intervention StudyStudies 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
- Supportive care
- 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, Irum Mir, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653739
- Sponsor's protocol ID
- FJWU/EC/2022/46
- Acronym
- MBSR
- Status last verified
- Sep 2023
- First submitted
- 19 Nov 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The findings of the study will be shared with the other researchers in the field through published research articles.
Publications
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.
PubMed 15673629Motta RW, Kefer JM, Hertz MD, Hafeez S. Initial evaluation of the Secondary Trauma Questionnaire. Psychol Rep. 1999 Dec;85(3 Pt 1):997-1002. doi: 10.2466/pr0.1999.85.3.997.
PubMed 10672764Simons,J.S., Gaher,R.M.(2005). The Distress Tolerance Scale: Development and Validation of a Self Report Measure. Motivation and Emotion,29,83-102. https://doi.org/10.1007/s11031-005-7955-3
Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction Intervention
- ClinicalTrials.gov ID
- NCT05653739
- Acronym / sponsor ID
- MBSR / FJWU/EC/2022/46
- Conditions
- Intervention Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 16 Dec 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 aim of the current study is to find out the impact of Mindfulness based stress reduction intervention on psychosocial factors associated with distress tolerance and quality of life among youth . The study is conducted on the youth age ranging from 15-24 years from districts Mardan and Nowshera of KP. Standardized tools are used to screen highly vulnerable cohort for further intervention. Eligible participants who scored higher on psychological distress, vicarious traumatization, and low on distress tolerance and quality of life and show their consent were recruited for the Intervention Phase. Participants were assigned randomly to experimental and control groups in intervention phase. Participants in the experimental group were given Mindfulness Based Stress Intervention (MBSR) training in the settings conducive for research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Intervention Group | Experimental | Behavioral: Mindfulness Based Stress Reduction InterventionMindfulness Based Stress Reduction Intervention , The training consists of eight weekly group sessions with the duration of approximately 2-2.5 hours with a trained instructor. Further participants were given daily audio-guided home practice (approximately 45 min/day), and a day-long mindfulness retreat (occurring during week sixth of the 8-week program) |
| Control Group | No intervention | –Participants in the control group were not given any intervention in order to compare with the experimental group. At the end of the study participants in this group were also offered relaxation trainings in order to deal with the psychological distress, quality of life and distress tolerance. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The participants studying in different public and private sector higher education institutes of Mardan and Nowshera districts of KP.
- Participants who volunteer to participate were included.
- Participants with High psychological distress, and Vicarious Trauma.
- Participants with low distress tolerance and low quality of life.
Key exclusion criteria (2 listed)
- Participants below 15 years or above 24 years i.e., the age range of youth (as recommended by WHO) will be excluded.
- Participants with any significant reported medical disease were also excluded.
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 InterventionMBSR is Mindfulness based intervention designed by Kabat-Zinn (1990) in order to deal with the stress and other psychological issues among individuals. This has been very effective intervention across different cultures . In this 8 week intervention participants will be given some home tasks to practice for at least 40 minutes a day. | Behavioural | Mindfulness Based Intervention Group |
Primary outcome
Changes in Psychological distress.
Time frame: Psychological distress will be measured before giving the intervention and at 8 weeks of intervention again the scale will be administered to measure psychological distress in order to check changes.
Psychological distress will be measured through Depression Anxiety and Stress Scale (DASS). After giving intervention to the participants it is expected that the participants will score low on the scale as low score is the indication of low level of psychological distress on DASS. Score above 32 will be considered as high level of psychological distress while score below 32 will be considered as indication of low level of psychological distress
Changes in Vicarious Trauma
Time frame: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on STQ.
Vicarious Trauma will be measured through Secondary Stress Trauma Questionnaire. Individuals scoring above 44 on the scale is the indication of high level of secondary traumatic symptoms.
Change in Distress Tolerance
Time frame: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score low on DTS i.e., their distress tolerance will be improved.
Distress Tolerance will be measured through Distress Tolerance Scale (DTS).Low scores on the scale is the indication of higher level of distress tolerance. So score above 34 will be selected for participants to be recruited for study.
change in Quality of Life
Time frame: The time frame for the completion of intervention is 8 weeks after which it is expected that participants will score high on WHOQOL-BREF.
Quality of life will be measured through The World Health Organization Quality of Life Scale (WHOQOL-BREF). High scores on the scale is the indication of high level of quality of life. Individuals scoring above 62 on the scale will be considered as scoring high on QOL for the current study. After participants are exposed to the intervention they will score higher on WHOQOL-BREF which means high quality of life.
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 28 Sep 2023.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Background: PubMed 15673629Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.
- Background: PubMed 10672764Motta RW, Kefer JM, Hertz MD, Hafeez S. Initial evaluation of the Secondary Trauma Questionnaire. Psychol Rep. 1999 Dec;85(3 Pt 1):997-1002. doi: 10.2466/pr0.1999.85.3.997.
- BackgroundSimons,J.S., Gaher,R.M.(2005). The Distress Tolerance Scale: Development and Validation of a Self Report Measure. Motivation and Emotion,29,83-102. https://doi.org/10.1007/s11031-005-7955-3
- Background: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Individual participant dataSharing planned: No. The findings of the study will be shared with the other researchers in the field through published research articles.
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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 Intervention Study, 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 4 inclusion and 2 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 28 Sep 2023. 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?
Changes in Psychological distress. (time frame: Psychological distress will be measured before giving the intervention and at 8 weeks of intervention again the scale will be administered to measure psychological distress in order to check changes.). The study lists 4 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 NCT05653739, 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 28 Sep 2023.