An interventional study of Behavioral Activation - single session intervention (BA-SSI) and 4-session Mindset intervention in Distress, Emotional, sponsored by Pakistan Institute of Living and Learning. Not yet recruiting at 1 site in Pakistan. Open to participants aged 12 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Prevention
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.
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.
Young persons (YP)
Inclusion Criteria:
Exclusion Criteria:
Schools Inclusion Criteria
Schools in the study areas are eligible to participate if they meet all the following criteria:
If the school meet the following exclusion criteria, they are ineligible to participate:
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.
Behavioral: Behavioral Activation - single session intervention (BA-SSI)
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.
Behavioral: 4-session Mindset intervention
At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above.
Single session intervention
This is comprised of 4 sessions.
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
Time frame: 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.
Time frame: 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
Time frame: Change in scores from baseline to 3-month follow up.
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").
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Total acceptability score at completion of one month intervention period.
Plan to share: 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
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pakistan Institute of Living and Learning