DepressionSAATHI-2NCT06017700
School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT
A study testing Interpersonal Psychotherapy Group in people with Depression, run by Transcultural Psychosocial Organization Nepal.
Trial summary
Globally a third of adolescents are at risk of depression with negative consequences for their health and development. Most of the world's adolescents live in low- and middle-income countries (LMICs) where access to treatment for depression is limited. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal Psychotherapy Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Jun 2024
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Attending a participating school
- Enrolled in Class 8, 9 or 11
- Depressed (i.e. scoring 10 or more on the PHQ-A)
- Functionally impaired (i.e. scoring 4 or more on the functional impairment tool)
Who cannot join
- In Class 10 and 12 because these students will be busy preparing for School Education and Plus 2 exams
- In Class 7 because they may be too young to benefit from IPT
- Current suicide plan or attempted suicide in the past three months because these adolescents require more acute, intensive treatment
- Conversion disorder ("chhopne") in the past three months because group-based treatments may not be appropriate
Trial locations and contacts
No sites are listed yet.
Kelly Clarke, PhD contact
About this study
Official title: School-based Group Interpersonal Therapy for Adolescents With Depression in Nepal: a Pilot Realist Cluster-randomised Controlled Trial
Globally a third of adolescents are at risk of depression with negative consequences for their health and development. Most of the world's adolescents live in low- and middle-income countries (LMICs) where access to treatment for depression is limited. Psychological interventions are treatments that seek to change behaviours, cognitions and feelings to improve mental health but few have been tested with adolescents in LMICs. This study will use a cluster randomised controlled trial approach to test one such intervention, interpersonal therapy (IPT) for adolescents in Chitwan district, Nepal. The current study will compare whether adolescents (aged 13-18) with depression who receive group interpersonal therapy improve more than adolescents who receive information about local mental health services but no active intervention (enhanced usual care). Adolescents' depressive symptoms will be assessed eight to ten weeks after IPT has finished using the Patient Health Questionnaire modified for adolescents (PHQ-A). We will also aim to assess the feasibility and acceptability of delivering group IPT in secondary schools in Chitwan, Nepal. In addition, in this trial we aim to refine our hypotheses around why IPT works, how, and for whom, and pilot the tools which will be used to answer these questions later in the full trial.
Read the detailed description
Depression and anxiety are leading causes of disability adjusted life years among adolescents aged 10-19 and can lead to social and educational impairment, substance misuse and suicide. The treatment gap for adolescent mental disorders is large, especially in low-and middle-income countries (LMICs). The WHO Mental Health Gap Action Programme outlines a role for psychological therapies in the treatment of child and adolescent emotional disorders such as depression and anxiety, however there is an urgent need to adapt these for use in LMICs. Between 2018 and 2020, our team including researchers and clinicians from TPO Nepal and King's College London adapted IPT for adolescents with depression in Nepal. Using an iterative mixed methods procedure, we adapted the WHO group IPT manual for delivery by school nurses and lay people in government secondary schools. We conducted an uncontrolled feasibility study of IPT with 62 adolescent boys and girls aged 13 to 19 in the mountainous district of Sindhupalchowk. Adolescents attended 82.3% (standard deviation 18.9) of group sessions. Depression and functional impairment improved between baseline and follow-up at 8-10 weeks post IPT: The Depression Self Rating Scale score decreased by 81% (95% confidence interval 70-95); functional impairment decreased by 288% (249-351).
Building on this previous research, we have designed a 4-stage, 5-year programme of work. The overall aim is to test the effectiveness and cost of scaling-up IPT in Nepal taking a "realist" evaluation approach where we will explore IPT's mechanisms of change and contextual factors that moderate its effects. This involves using formative research to develop an intervention theory of change from which we formulate hypotheses about how intervention mechanisms might interact with context to produce outcomes (context mechanism-outcome configurations, CMOCs).
According to this programme, Stage 1 (Formative Phase) is already completed. Currently we are applying for Stage 2, which is a pilot cluster randomized controlled trial (CRCT-pilot) of IPT for adolescent depression in Chitwan, a district in the lowland region of Nepal. As part of the current application, we aim to 1) test the feasibility and acceptability of the trial protocols, 2) pilot the qualitative and quantitative tools and 3) refine the theory of change hypotheses. Building on it, we will later apply for Stage 3 which will be a full cluster randomized controlled trial assessing the effectiveness/cost-effectiveness of IPT (CRCT-full) and Stage 4 which will consist of testing the CMOs using quantitative data from the full trial.
The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26). The acceptability of the intervention, randomisation, tools, uptake, utility of the intervention, facilitators' fidelity to the manual, mental health outcomes, and cost of design and delivery of the intervention will be assessed. The intervention process data will be also collected. This will include FGDs and interviews with adolescents and their parents, facilitators, nurses, teachers, and school principals to explore feasibility and acceptability of the intervention and study procedures.
- Conditions
- Depression
- Being tested
- Interpersonal Psychotherapy Group, Enhanced Usual Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy GroupBehavioural
IPT is a psychological intervention that focuses on four common problems that trigger depression: grief, disputes, role transitions and social isolation. Using techniques and strategies such as linking mood to event and event to mood, role play and skill-building, IPT encourages the individual to analyse and improve their interpersonal relationships context. IPT was developed in the USA to treat depressed adults but it has also been used to treat other mental disorders and among different age groups.
Enhanced Usual CareBehavioural
Participants attending schools in the control arm will receive enhanced usual care. In intervention and control arms, we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package (mhGAP). Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Adolescents in the control cluster reporting a current suicide plan (i.e. in the past 2 weeks) or suicide attempt in the past three months will be assessed by a psychosocial counsellor employed through the project and offered counselling or referral to other services as per need.
| Study group | Role | What they receive |
|---|---|---|
| IPT-G | Experimental | Participants in the intervention arm will receive group interpersonal therapy in schools facilitated by trained laypersons. Groups are gender specific and comprise 6-8 adolescents. There are ten group sessions (approximately 90 min each, delivered weekly): in the first session the facilitator will focus on encouraging participants to review and share their interpersonal problems and instilling hope for recovery. In the middle sessions (2-9) participants will learn and practice interpersonal skills and offer and receive support from group members to resolve their problems. In the last session, they will review and celebrate progress and make plans to tackle future problems. Receives: Behavioral: Interpersonal Psychotherapy Group |
| Enhanced Usual Care | Active comparator | Participants in the control arm will receive enhanced usual care. In intervention and control arms we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package. Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Participants in the control cluster reporting a current suicide plan or a suicide attempt in the past three months at baseline or in subsequent surveys will be assessed by a psychosocial counsellor employed through the project and offered one to one counselling as needed. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Patient Health Questionnaire for Adolescents (PHQ-A) will be used to measure depression. PHQ-A is a 9-item scale. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 27 with high score indicating severity of anxiety.
Measured: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
Secondary outcomes (4)
Anxiety
Generalised Anxiety Disorder (GAD-7) will be used to measure anxiety. GAD-7 has 7-items and respondents are asked to score their experience of 7 common symptoms of anxiety in the past two weeks. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 21 with high score indicating severity of anxiety.
Measured: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
Functional Impairment
A locally-developed Functional impairment scale (FIS) will be used to measure impairment in daily activities. FIS is 11-item scale to assess impairment in daily functioning. It consists of 10-items, representing daily activities that adolescents generally do for themselves, family and community. It has a 4-point rating scale where 0 indicates "not at all' and 3 indicates "always". The total score of FIS ranges from 0 to 33 with higher score indicating more impairment in daily activities.
Measured: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
School Attendance
School attendance calculated as percentage of days attended in a standardised two-week period (excluding school closures).
Measured: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
PTSD
PTSD symptoms will be assessed with an 8-item shortened version of the PCL-5. It has a 4-point rating scale where 0 indicates "not at all' and 3 indicates "extremely". The total score ranges from 0 to 24 with higher score indicating more PTSD symptoms.
Measured: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Model description
- The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the first group session (week 5), after the sixth group session (week 12), at endline (weeks 20-21) and at follow-up (weeks 45-46). A caregiver survey will be administered at baseline and endline. Focus groups and interviews will be conducted with patients, caregivers, teachers, nurses, school principals.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcultural Psychosocial Organization Nepal
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Kamal Gautam, MD, Study director, Transcultural Psychosocial Organization Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017700
- Sponsor's protocol ID
- MR/W00285X/1
- Acronym
- SAATHI-2
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The quantitative datasets generated during and/or analysed during the current study will be available upon request from Dr Kelly Rose-Clarke kelly.rose-clarke@kcl.ac.uk
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Group Interpersonal Therapy for Adolescents With Depression in Nepal: a Pilot Realist Cluster-randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06017700
- Acronym / sponsor ID
- SAATHI-2 / MR/W00285X/1
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Transcultural Psychosocial Organization NepalUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 Aug 2023 (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.
Globally a third of adolescents are at risk of depression with negative consequences for their health and development. Most of the world's adolescents live in low- and middle-income countries (LMICs) where access to treatment for depression is limited. Psychological interventions are treatments that seek to change behaviours, cognitions and feelings to improve mental health but few have been tested with adolescents in LMICs. This study will use a cluster randomised controlled trial approach to test one such intervention, interpersonal therapy (IPT) for adolescents in Chitwan district, Nepal. The current study will compare whether adolescents (aged 13-18) with depression who receive group interpersonal therapy improve more than adolescents who receive information about local mental health services but no active intervention (enhanced usual care). Adolescents' depressive symptoms will be assessed eight to ten weeks after IPT has finished using the Patient Health Questionnaire modified for adolescents (PHQ-A). We will also aim to assess the feasibility and acceptability of delivering group IPT in secondary schools in Chitwan, Nepal. In addition, in this trial we aim to refine our hypotheses around why IPT works, how, and for whom, and pilot the tools which will be used to answer these questions later in the full trial.
Detailed description
Depression and anxiety are leading causes of disability adjusted life years among adolescents aged 10-19 and can lead to social and educational impairment, substance misuse and suicide. The treatment gap for adolescent mental disorders is large, especially in low-and middle-income countries (LMICs). The WHO Mental Health Gap Action Programme outlines a role for psychological therapies in the treatment of child and adolescent emotional disorders such as depression and anxiety, however there is an urgent need to adapt these for use in LMICs. Between 2018 and 2020, our team including researchers and clinicians from TPO Nepal and King's College London adapted IPT for adolescents with depression in Nepal. Using an iterative mixed methods procedure, we adapted the WHO group IPT manual for delivery by school nurses and lay people in government secondary schools. We conducted an uncontrolled feasibility study of IPT with 62 adolescent boys and girls aged 13 to 19 in the mountainous district of Sindhupalchowk. Adolescents attended 82.3% (standard deviation 18.9) of group sessions. Depression and functional impairment improved between baseline and follow-up at 8-10 weeks post IPT: The Depression Self Rating Scale score decreased by 81% (95% confidence interval 70-95); functional impairment decreased by 288% (249-351).
Building on this previous research, we have designed a 4-stage, 5-year programme of work. The overall aim is to test the effectiveness and cost of scaling-up IPT in Nepal taking a "realist" evaluation approach where we will explore IPT's mechanisms of change and contextual factors that moderate its effects. This involves using formative research to develop an intervention theory of change from which we formulate hypotheses about how intervention mechanisms might interact with context to produce outcomes (context mechanism-outcome configurations, CMOCs).
According to this programme, Stage 1 (Formative Phase) is already completed. Currently we are applying for Stage 2, which is a pilot cluster randomized controlled trial (CRCT-pilot) of IPT for adolescent depression in Chitwan, a district in the lowland region of Nepal. As part of the current application, we aim to 1) test the feasibility and acceptability of the trial protocols, 2) pilot the qualitative and quantitative tools and 3) refine the theory of change hypotheses. Building on it, we will later apply for Stage 3 which will be a full cluster randomized controlled trial assessing the effectiveness/cost-effectiveness of IPT (CRCT-full) and Stage 4 which will consist of testing the CMOs using quantitative data from the full trial.
The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26). The acceptability of the intervention, randomisation, tools, uptake, utility of the intervention, facilitators' fidelity to the manual, mental health outcomes, and cost of design and delivery of the intervention will be assessed. The intervention process data will be also collected. This will include FGDs and interviews with adolescents and their parents, facilitators, nurses, teachers, and school principals to explore feasibility and acceptability of the intervention and study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the first group session (week 5), after the sixth group session (week 12), at endline (weeks 20-21) and at follow-up (weeks 45-46). A caregiver survey will be administered at baseline and endline. Focus groups and interviews will be conducted with patients, caregivers, teachers, nurses, school principals.
| Arm | Type | Receives |
|---|---|---|
| IPT-G | Experimental | Behavioral: Interpersonal Psychotherapy GroupParticipants in the intervention arm will receive group interpersonal therapy in schools facilitated by trained laypersons. Groups are gender specific and comprise 6-8 adolescents. There are ten group sessions (approximately 90 min each, delivered weekly): in the first session the facilitator will focus on encouraging participants to review and share their interpersonal problems and instilling hope for recovery. In the middle sessions (2-9) participants will learn and practice interpersonal skills and offer and receive support from group members to resolve their problems. In the last session, they will review and celebrate progress and make plans to tackle future problems. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareParticipants in the control arm will receive enhanced usual care. In intervention and control arms we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package. Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Participants in the control cluster reporting a current suicide plan or a suicide attempt in the past three months at baseline or in subsequent surveys will be assessed by a psychosocial counsellor employed through the project and offered one to one counselling as needed. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Attending a participating school
- Enrolled in Class 8, 9 or 11
- Depressed (i.e. scoring 10 or more on the PHQ-A)
- Functionally impaired (i.e. scoring 4 or more on the functional impairment tool)
Key exclusion criteria (4 listed)
- In Class 10 and 12 because these students will be busy preparing for School Education and Plus 2 exams
- In Class 7 because they may be too young to benefit from IPT
- Current suicide plan or attempted suicide in the past three months because these adolescents require more acute, intensive treatment
- Conversion disorder ("chhopne") in the past three months because group-based treatments may not be appropriate
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 |
|---|---|---|
| Interpersonal Psychotherapy GroupIPT is a psychological intervention that focuses on four common problems that trigger depression: grief, disputes, role transitions and social isolation. Using techniques and strategies such as linking mood to event and event to mood, role play and skill-building, IPT encourages the individual to analyse and improve their interpersonal relationships context. IPT was developed in the USA to treat depressed adults but it has also been used to treat other mental disorders and among different age groups. | Behavioural | IPT-G |
| Enhanced Usual CareParticipants attending schools in the control arm will receive enhanced usual care. In intervention and control arms, we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package (mhGAP). Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Adolescents in the control cluster reporting a current suicide plan (i.e. in the past 2 weeks) or suicide attempt in the past three months will be assessed by a psychosocial counsellor employed through the project and offered counselling or referral to other services as per need. | Behavioural | Enhanced Usual Care |
Primary outcome
Depression
Time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
Patient Health Questionnaire for Adolescents (PHQ-A) will be used to measure depression. PHQ-A is a 9-item scale. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 27 with high score indicating severity of anxiety.
4 secondary outcomes
Anxiety
Time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
Functional Impairment
Time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
School Attendance
Time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
PTSD
Time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Yes. The quantitative datasets generated during and/or analysed during the current study will be available upon request from Dr Kelly Rose-Clarke kelly.rose-clarke@kcl.ac.uk
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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.
Kelly Clarke, PhD contact
Kamal Gautam, MD study director
Transcultural Psychosocial Organization Nepal
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy Group in people with Depression, run by Transcultural Psychosocial Organization Nepal.
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 4 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Nagendra Luitel, PhD (9841333725, luitelnp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)). 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 30 Aug 2023.