Clinical trial NCT06017700: School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT
Official title: School-based Group Interpersonal Therapy for Adolescents With Depression in Nepal: a Pilot Realist Cluster-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Transcultural Psychosocial Organization Nepal
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-08-30
Enrollment: 128
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Depression
timeFrame: 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:
measure: Anxiety
timeFrame: 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)
measure: Functional Impairment
timeFrame: 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)
measure: School Attendance
timeFrame: 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)
measure: PTSD
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Transcultural Psychosocial Organization Nepal
name: Kamal Gautam, MD
role: STUDY_DIRECTOR
References: