Distress, EmotionalMindset-PKNCT06442007
Universally Delivered Interventions for Young People
A study testing Behavioral Activation - single session intervention (BA-SSI) and 4-session Mindset intervention in people with Distress, Emotional, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Mental health problems are amongst the major contributors to disease burden globally. According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Distress, Emotional
- What is being tested?
- Behavioral Activation - single session intervention (BA-SSI) and 4-session Mindset intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth is between the age 12-15 years (inclusive) at the time of study enrollment.
- Youth has one parent or legal guardian to give consent.
- Youth speaks Urdu well enough to complete the paper based intervention.
Who cannot join
- Intellectual disability, as this may undermine comprehension of intervention material.
- Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).
- Schools Inclusion Criteria
- Schools in the study areas are eligible to participate if they meet all the following criteria:
- the school authority agrees to participate;
- the schools shall be non-specialist public schools;
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- school contains at least 80 students; Exclusion criteria
- If the school meet the following exclusion criteria, they are ineligible to participate:
- the school authority refuses to participate;
- a specialist and/or independent or private school;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Public school for boys 1
Rawalpindi, Punjab Province
Tayyeba Kiran, PhD, 0923328262142, tayyebakiran@gmail.com
About this study
Official title: A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
Mental health problems are amongst the major contributors to disease burden globally.
According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Read more
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
Read the detailed description
A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan.
Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.
Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.
All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.
- Conditions
- Distress, Emotional
- Being tested
- Behavioral Activation - single session intervention (BA-SSI), 4-session Mindset intervention
- Keywords
- adolescents, anxiety, depression, single session interventions, growth mindset, Pakistan
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation - single session intervention (BA-SSI)Behavioural
Single session intervention
4-session Mindset interventionBehavioural
This is comprised of 4 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation - single session intervention (BA-SSI) | Experimental | This is comprised of 5 five components:
1. Discussion on the rationale of the behavioral activation
2. Awareness raising about distress, including how behavior shapes feelings and thoughts;
3. a life values assessment
4. the creation of an activity action plan
5. an exercise in which youths write about benefits that might result from engaging in each activity, an obstacle that might keep them from doing the activities and a strategy for overcoming the identified obstacles. Receives: Behavioral: Behavioral Activation - single session intervention (BA-SSI) |
| 4-session Mindset intervention | Active comparator | This is comprised of a growth mindset module (2 sessions), a gratitude module (1 session) and a value affirmations module (1 session). Sessions are delivered weekly (over 4 weeks) and each session lasts for an hour. Reading and writing activities and group discussions are included in each session. Participants are supposed to complete homework exercises are assigned between sessions. Receives: Behavioral: 4-session Mindset intervention |
| Waiting list control group | No intervention | At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
This will be monitored through a research trial log. This log will include information about number of schools approached, number of schools eligible to participate, number of schools consented to participate, number of YP approached, number of eligible YP and number of those who consented to participate
Measured: Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment
Feasibility of intervention
Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log.
Measured: Retention of participants in the Intervention at the completion of one month intervention period.
Depression
The Patient Health Questionnaire -8 will be used to assess the symptoms of depression. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be used to assess depression severity
Measured: Change in scores from baseline to 3-month follow up.
Secondary outcomes (5)
The Revised Child Anxiety and Depression Scale
It is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Items are rated on a 4-point Likert-scale from 0 ("never") to 3 ("always").
Measured: Change in scores from baseline to 3-month follow up
Growth Mindset scale
The mindset scale is comprised of 3 items regarding participants' views about the mindset such as intelligence, personality etc. There is not cutoff score. Higher total summed scores indicate stronger fixed mindsets, and lower scores, stronger growth mindsets.
Measured: Change in scores from baseline to 3-month follow up
Beck's hopelessness Scale short version
A 4-item short version of the Hopelessness Scale includes all the affective, cognitive and motivational components of hopelessness.
Measured: Change in scores from baseline to 3-month follow up
EuroQol Quality of Life scale
This scale provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. higher score indicare greater disability. there is no cutoff score.
Measured: Change in scores from baseline to 3-month follow up
Program Feedback Scale
youths will be asked to complete a series of questions regarding their experience with the intervention to which they were assigned. highre score will indicate greater level of acceptability. there is no cut off score.
Measured: Total acceptability score at completion of one month intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 May 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, EmotionalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arm study. Schools would be the unit of cluster.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Fatima Jinnah Women University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442007
- Sponsor's protocol ID
- Mindset-PK
- Acronym
- Mindset-PK
- Status last verified
- Dec 2024
- First submitted
- 17 May 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is the feasibility study and interventions will continue to refine and adapt. The IP is owned by the Pakistan Institute of Living and Learning
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-arm Multi-Center Exploratory Trial of Universally Delivered Interventions for Prevention of Anxiety and Depression in Young People in Pakistan
- ClinicalTrials.gov ID
- NCT06442007
- Acronym / sponsor ID
- Mindset-PK / Mindset-PK
- Conditions
- Distress, Emotional
- Keywords
- adolescents, anxiety, depression, single session interventions, growth mindset, Pakistan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Fatima Jinnah Women University
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Jun 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.
Mental health problems are amongst the major contributors to disease burden globally.
According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
Detailed description
A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan.
Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.
Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.
All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three arm study. Schools would be the unit of cluster.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation - single session intervention (BA-SSI) | Experimental | Behavioral: Behavioral Activation - single session intervention (BA-SSI)This is comprised of 5 five components: 1. Discussion on the rationale of the behavioral activation 2. Awareness raising about distress, including how behavior shapes feelings and thoughts; 3. a life values assessment 4. the creation of an activity action plan 5. an exercise in which youths write about benefits that might result from engaging in each activity, an obstacle that might keep them from doing the activities and a strategy for overcoming the identified obstacles. |
| 4-session Mindset intervention | Active comparator | Behavioral: 4-session Mindset interventionThis is comprised of a growth mindset module (2 sessions), a gratitude module (1 session) and a value affirmations module (1 session). Sessions are delivered weekly (over 4 weeks) and each session lasts for an hour. Reading and writing activities and group discussions are included in each session. Participants are supposed to complete homework exercises are assigned between sessions. |
| Waiting list control group | No intervention | –At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth is between the age 12-15 years (inclusive) at the time of study enrollment.
- Youth has one parent or legal guardian to give consent.
- Youth speaks Urdu well enough to complete the paper based intervention.
Key exclusion criteria (10 listed)
- Intellectual disability, as this may undermine comprehension of intervention material.
- Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).
- Schools Inclusion Criteria
- Schools in the study areas are eligible to participate if they meet all the following criteria:
- the school authority agrees to participate;
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 |
|---|---|---|
| Behavioral Activation - single session intervention (BA-SSI)Single session intervention | Behavioural | Behavioral Activation - single session intervention (BA-SSI) |
| 4-session Mindset interventionThis is comprised of 4 sessions. | Behavioural | 4-session Mindset intervention |
Primary outcome
Feasibility of recruitment
Time frame: Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment
This will be monitored through a research trial log. This log will include information about number of schools approached, number of schools eligible to participate, number of schools consented to participate, number of YP approached, number of eligible YP and number of those who consented to participate
Feasibility of intervention
Time frame: Retention of participants in the Intervention at the completion of one month intervention period.
Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log.
Depression
Time frame: Change in scores from baseline to 3-month follow up.
The Patient Health Questionnaire -8 will be used to assess the symptoms of depression. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be used to assess depression severity
5 secondary outcomes
The Revised Child Anxiety and Depression Scale
Time frame: Change in scores from baseline to 3-month follow up
Growth Mindset scale
Time frame: Change in scores from baseline to 3-month follow up
Beck's hopelessness Scale short version
Time frame: Change in scores from baseline to 3-month follow up
EuroQol Quality of Life scale
Time frame: Change in scores from baseline to 3-month follow up
Program Feedback Scale
Time frame: Total acceptability score at completion of one month intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No. This is the feasibility study and interventions will continue to refine and adapt. The IP is owned by the Pakistan Institute of Living and Learning
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation - single session intervention (BA-SSI) and 4-session Mindset intervention in people with Distress, Emotional, run by Pakistan Institute of Living and Learning 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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 10 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tayyeba Kiran, PhD (0923328262142, tayyebakiran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment). 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 10 Dec 2024.