School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT

NCT06017700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Interpersonal Psychotherapy Group

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.

BEHAVIORAL

Enhanced Usual Care

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.

Sponsors & Collaborators

Principal Investigators

  • Kamal Gautam, MD · Transcultural Psychosocial Organization Nepal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-06-30
Completion
2024-06-30

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06017700 on ClinicalTrials.gov