Pilot Implementation of Depression Screening and Treatment for Adolescents in Mozambican Primary Care
Phase: NA
Conditions: Depression, Adolescent Behavior
Sponsor: Columbia University

 
 
 
 
 
Pilot Implementation of Depression Screening and 
Treatment for Adolescents in Mozambican Primary Care 
 
 
 
NCT05476237 
 
July 30, 2025 
 

BACKGROUND 
 
Study Purpose and Rationale 
Mental disorders are the number one cause of disability in adolescents worldwide, 
accounting for 45% of years lived with disability (Gore, Bloem et al. 2011). It is estimated that 
90% of adolescents live in lower middle-income countries (LMICs), (Organization 2008) and that 
10-20% of these adolescents have one or more mental disorders (Erskine, Moffitt et al. 2015). 
Despite the substantial burden of mental illness in LMICs, adolescent mental health services are 
extremely limited in these regions.(Morris, Belfer et al. 2011) Because untreated mental illness 
hinders individual, social, and economic prosperity in the long term, (Chen, Cohen et al. 2006, 
Erskine, Moffitt et al. 2015) improving adolescent mental health services has become a focus of 
global development efforts (Collins, Insel et al. 2013, Votruba, Thornicroft et al. 2016). In high-
income countries, mental healthcare integrated into primary care settings is effective for treating 
adolescent mental illness (Asarnow, Rozenman et al. 2015). Mental health services delivered by 
non-specialists (task-shifting) within primary care of LMICs has been proposed as an efficient and 
sustainable way to close the adolescent mental health treatment gap (Patel, Kieling et al. 2013, 
Juengsiragulwit 2015). However, research is needed to determine how to effectively integrate 
interventions for managing adolescent mental disorders within LMIC primary care settings (Patel, 
Kieling et al. 2013, Juengsiragulwit 2015). 
Mozambique is the fourth poorest country in the world (The World Bank. World Bank 
Open Data. Washington) and has just 15 psychiatrists and 180 psychologists to serve its population 
of 29 million (Santos, Wainberg et al. 2016). Given this scarcity of human resources, the 
Mozambican Ministry of Health (MoH) has focused on integrating psychiatric treatment into 
primary care, utilizing a task-shifting approach. In 1996, the MoH began training PsyTechs to 
deliver psychiatric services at primary care clinics through a 30-month theoretical and practical 
course, and PsyTechs now practice in all 135 districts of Mozambique (Santos, Wainberg et al. 
2016). However, even with the introduction of PsyTechs, there are still just 1.48 mental health 
specialists for every 100,000 Mozambicans (Santos, Wainberg et al. 2016). Since 2017, the MoH 
has begun further expanding access to adult mental health services by training nonspecialists 
(nurses, medical technicians, and community health workers) to screen for mental disorders and 
provide treatment for common mental illnesses or referrals to specialized care for serious mental 

illnesses. Despite this progress toward increasing services for adults, Mozambique continues to 
have very little infrastructure for treatment of adolescent mental disorders. The results of this study 
will contribute an understanding of how to integrate mental health treatment for children and 
adolescents in primary care clinics of lowresource settings, and its impact on patient outcomes. It 
will also produce data on the challenges and facilitators to implementation of mental healthcare 
for adolescents in these settings. This knowledge will be applied to scale-up of services in 
Mozambique and may be used to inform scale-up of interventions for youth globally, helping to 
reduce the global mental health treatment gap. 
 
Research Aims & Abstracts 
We aim to examine patient and implementation outcomes of task-shifted depression 
screening and group IPT-A compared to treatment as usual in a pilot cluster-randomized trial at 
four PCCs. Guided by Proctor’s Taxonomy of Implementation Outcomes (Proctor, Silmere et al. 
2011), we will assess patient and implementation outcomes through quantitative measures and 
post-treatment qualitative interviews with adolescents and providers in the IPT-A and TAU study 
arms. We hypothesize that the IPT-A arm will have better patient and implementation and patient 
outcomes than TAU. 
Globally, mental disorders are the largest contributor to burden of disease in adolescents 
(Gore Bloem et al. 2011). However, the majority of adolescents with mental illness in low- and 
middle-income countries (LMICs) do not have access to treatment (Kieling, Baker-Henningham 
et al. 2011, Patel, Kieling et al. 2013) and contextually appropriate strategies for delivering 
evidence-based practices for managing mental disorders are needed to expand services to these 
areas. To broaden engagement in care, new settings for adolescent mental health services must be 
identified. Evidence-based interventions for managing adolescent mental disorders integrated 
within primary care have been effective in high-income countries (Asarnow, Rozenman et al. 
2015) but very limited data exist on how to adapt and implement these EBP in LMIC primary care 
(Patel, Kieling et al. 2013, Mertens, Ward et al. 2014). We previously conducted a qualitative 
assessment of barriers and facilitators to implementation from the perspective of adolescents, 
caregivers, providers, and policymakers. We then developed our plan to implement integrated 
adolescent depression services by holding a series of workshops with local stakeholders—
including Ministry of Health and Education staff involved in adolescent, mental health, and 

primary care programming; staff from local NGOs that have experience implementing adolescent 
health programs in primary care; and primary care providers. Now we aim to pilot test the 
implementation strategy developed in these workshops. We will examine patient and 
implementation outcomes of depression screening and group IPT-A compared to treatment as usual 
in a pilot cluster-randomized trial at four primary PCCs with two PCC as the IPT-A arm and two 
PCC as the TAU arm. 
 
STUDY DESIGN 
 
We will examine patient and implementation outcomes of depression screening and group 
interpersonal therapy for adolescents (IPT-A) compared to treatment as usual in a pilot cluster 
randomized trial at four primary care clinics (PCC). Two PCC will be randomized to routine 
screening and IPT-A (intervention) and the other two PCC with be randomized to treatment as 
usual (TAU). In the IPT-A arm, providers (nurses and/or medical technicians) at PCCs will be 
trained to conduct paper-based depression screening as part of routine clinical care. Two providers 
(nurses and/or medical technicians) per clinic will be trained to facilitate group IPT-A. In the TAU 
arm, primary care providers will continue referring adolescents to specialized mental health 
services per existing protocol (when they believe the adolescent is struggling with a mental health 
problem or when the adolescent/their caregiver requests a referral to mental health services). 
Treatment providers in the TAU arm are the Psychiatric Technicians and psychologists at primary 
care clinics to whom adolescents are currently referred. 
 
Study procedures 
In the treatment study arm, we are evaluating the impact of IPT-A on depression symptoms 
in adolescents as well as the feasibility and acceptability of its introduction in primary care clinics. 
Therefore, adolescents identified as having depression, via screening on the PHQ-A, will be 
referred to IPT-A treatment groups instead of being referred to Psychiatric Technicians and 
psychologists in Mental Health Services at the PCC who provide unstructured psychotherapy 
(TAU). 
IPT-A (Treatment) Study Arm: Prior to initiation of the pilot study, we will train providers 
at the PCC in the IPT-A arm to screen for depression using the Patient Health Questionnaire for 

Adolescents (PHQ-A). Training will include didactics and role-plays to practice administration of 
the PHQ-A with corrective feedback and evaluations. Two providers per PCC will be selected to 
be trained on delivery of group IPT-A. Training will occur via an apprenticeship model which 
includes trainers (i.e., non-local experts in the mental health intervention), supervisors (i.e., local 
individuals chosen for an advanced role), and counselors (i.e., local individuals who provide the 
interventions). A group IPT-A training expert will train two psychologists from the MoH. 
Following this, the MoH psychologists will train the two staff members at the IPT-A arm PCC to 
facilitate group IPT-A. The MoH psychologists will supervise PCC providers for an additional 3 
months to achieve competency prior to pilot trial initiation. 
Every adolescent who attends PCCs will be screened for depression as part of their routine 
clinical care. Providers will use the PHQ-A for screening. Using a script, trained research assistants 
will introduce the study to adolescents who screen positive for depression and their caregivers. If 
interested, research assistants will collect patient demographic data (age in years, gender) on a 
questionnaire to verify eligibility. 
Group IPT-A begins with one individual session, followed by ten group sessions, and ends 
with one individual session. As part of each Group IPT-A session, providers will collect data from 
adolescents on depression symptoms using the PHQ-A at treatment initiation, 6 weeks after 
treatment initiation (treatment midpoint), 12 weeks after treatment initiation (end of treatment), 
and 24 weeks after treatment initiation (3-month follow-up). The Project Coordinator will call 
adolescents who do not enter or who discontinue treatment to arrange data collection at these time 
points. For adolescents who do not enter treatment, the first scheduled session will be considered 
the “treatment initiation” timepoint. 
Data on treatment fidelity will be collected via the Group IPT-A Fidelity Checklist, 
completed by the local IPT-A trainers at 10 randomly-selected sessions for each provider. On the 
Fidelity Checklist, providers are scored for low (1), moderate (2), or high (3) adherence to each 
essential element of treatment, and fidelity is measured by the total score. 
 
TAU Study Arm: Following usual procedures, providers at the TAU arm PCC will refer 
adolescents who request mental health care or are suspected of mental illness to Psychiatric 
Technicians or psychologists at the primary care clinic. Trained research assistants will then inform 
these adolescents and their caregivers about the proposed study. If interested, research assistants 

will administer the brief demographic questionnaire and the PHQ-A to determine eligibility. For 
eligible adolescents, For eligible adolescents, research assistants will conduct informed consent 
and assent procedures. Adolescents will be referred to treatment by mental health specialists at the 
PCC, per existing protocol. Research assistants will visit the PCC at the patients’ treatment 
appointment times to collect data on depression symptoms and functioning. Similar to protocol for 
the IPT-A arm, data will be collected using the PHQ-A at treatment initiation, 6 weeks after 
treatment initiation, 12 weeks after treatment initiation, and 24 weeks after treatment initiation. 
While the treatment timeline in TAU will not necessarily be aligned with IPT-A (e.g. 12 weeks 
may not be the end of treatment that is provided), we will use these timepoints for both IPT-A and 
TAU adolescents to measure symptom improvement over time consistently across study arms. The 
Project Coordinator will call adolescents who do not enter or who discontinue treatment to arrange 
data collection at these time points. For adolescents who do not enter treatment, the first scheduled 
session will be considered the “treatment initiation” timepoint. 
 
Post Treatment Data Collection: After the final treatment session (either full course of 
treatment or after the adolescent discontinues treatment), research assistants will conduct semi-
structured exit interviews with participating adolescents and their caregivers (IPT-A arm only), 
which will be digitally audio-recorded, to collect feedback on acceptability and appropriateness of 
the depression care they received. Research assistants will also conduct exit interviews, which will 
be digitally-audio recorded, with PCC providers (IPT-A arm only) after the completion of the pilot 
trial period to collect feedback on acceptability and appropriateness of depression care they 
provided. Data on treatment penetration (number adolescents entering treatment/ number referred), 
feasibility (retention in treatment, measured as number of treatment sessions completed/number of 
planned treatment sessions), and sustainability (penetration and retention in the 6 months following 
trial end) will be collected by research assistants from clinic records (both study arms). 
 
STATISTICAL PROCEDURES 
 
Quantitative analysis: Power was calculated conservatively based on participation of 90 
adolescents, anticipating possible loss-to-follow up of ~10% as seen in similar trials (Bolton, Bass 
et al. 2007, Murray, Skavenski et al. 2015). Assuming an intra-PCC correlation coefficient of 0.02- 

0.10,(Hemming, Girling et al. 2011) we will have 80% power to detect a moderate 0.6 to large 
>1.0 effect size of continuous outcomes using a two-sided z-test with an alpha level of 0.05. All 
analyses between arms will be based on intention to treat. Symptom change between baseline and 
treatment midpoint, treatment end, and 3- month follow-up will be compared in the IPT-A versus 
TAU study arms through mixedmodels linear regression analysis, treating PCC as a random effect 
and baseline symptoms and treatment arm as fixed effects. Subsequently, patient age and gender 
will be introduced into the model as independent fixed effects to adjust for their potential effect on 
symptom change. Similar analyses will be used to compare penetration, retention, and 
sustainability across arms. Within each arm, I will conduct exploratory analyses of the effect of 
adolescent age and gender on symptom change as well as provider age, gender, and years working 
in PCCs on fidelity to treatment using linear regression. 
Qualitative analysis: Patient and provider perspectives on acceptability and 
appropriateness of IPT-A or TAU will be evaluated using the Framework Method (Spencer and 
Ritchie 2002, Gale, Heath et al. 2013). All interviews will be digitally recorded, professionally 
transcribed, and loaded into Dedoose software for qualitative data management and analysis. We 
will independently read all transcripts and develop an open coding schema based on a priori and 
emergent themes. We will use Dedoose to code all data consistent with the Analytic Framework. 
To establish coding reliability, two research team members will independently code up to 10% of 
the transcripts. We will meet weekly during this process to review definitions and assignments of 
codes and to resolve differences until interrater reliability Kappa coefficient is higher than 
0.7.(Landis and Koch 1977) If additional codes emerge during this process, they will be added to 
the codebook. Once all data are coded, they will be charted and assessed with a framework matrix.