Adolescent Depression Screening and Treatment in Mozambican Primary Care

NCT ID: NCT05476237

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-07-31

Brief Summary

This is a cluster-randomized pilot trial of depression screening and treatment implementation at four Youth-friendly Health Services (YFHS) in primary care clinics, two in Maputo City and two in Maputo Province. YFHS will be stratified by urbanicity, such that one YFHS in Maputo City and one YFHS in Maputo Province will be randomized to interpersonal psychotherapy (IPT)-A and the other YFHS in each location with be randomized to treatment as usual (TAU).

Detailed Description

Mental disorders are the leading cause of disability among adolescents worldwide, but only a very small minority, mostly in high-resource settings, have access to mental health care. The investigators' work is focused on understanding how to increase access to mental health care for adolescents in low-resource settings. In Mozambique, where this work is based, there are just 15 psychiatrists and 180 psychologists to serve its population of 29 million. In collaboration with local stakeholders, including governmental policymakers and primary care providers, the investigators developed a plan to implement care for adolescent depression in primary care settings. The investigators now aim to examine changes in adolescent depression and acceptability of primary care-based mental health services compared to treatment as usual.

Conditions

Depression; Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

TAU

Psychologists or PsyTechs in mental health services of primary care clinics will provide individual psychotherapy to depressed adolescents in the TAU arm. Local mental health professionals providing depression treatment in the TAU arm will not have been trained on IPT for adults or adolescents. Also, the two Ministry of Health psychologists trained as trainers of IPT-AG will not provide treatment in the TAU Arm.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).

IPT-AG

Group IPT-AG will be facilitated by the trained providers at each YFHS using the IPT-AG manual adapted to the Mozambican context. Adolescents will participate in 12 weekly sessions. The first and last sessions will be one-on-one with the provider. The first session is used for the participant and provider to develop a treatment plan and the last session is to prepare for treatment termination. All other sessions will be conducted in groups of 6-8 adolescents.

Group Type: EXPERIMENTAL

Group Interpersonal Therapy for Adolescents (IPT-AG)

Intervention Type: BEHAVIORAL

IPT-AG is a ten session, group therapy for adolescents. Each group contains 6-8 adolescents who attend weekly sessions together. The goals of IPT-AG are: 1) to reduce depression symptoms, and 2) to improve interpersonal relationships. Another aim of the group format is to increase adolescents' experience with positive social interactions and to reduce social isolation.

Interventions

Group Interpersonal Therapy for Adolescents (IPT-AG)

IPT-AG is a ten session, group therapy for adolescents. Each group contains 6-8 adolescents who attend weekly sessions together. The goals of IPT-AG are: 1) to reduce depression symptoms, and 2) to improve interpersonal relationships. Another aim of the group format is to increase adolescents' experience with positive social interactions and to reduce social isolation.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).

Intervention Type: BEHAVIORAL

Other Intervention Names

TAU

Eligibility Criteria

Inclusion Criteria

1. Providers:

1. IPT-AG Arm: YFHS staff will be included in the study if they (a) conduct screening for depression and/or group IPT-AG and (b) provide consent to participate in the study.

2. TAU Arm: YFHS staff will be included in the study if they (a) provide referrals for adolescents suspected of having mental illness or seeking mental health services and (b) provide consent to participate in the study. Treatment providers (Psychiatric Technicians and psychologists) will be included in the study if they (a) treat adolescents referred from participating YFHS for depression and (b) provide consent to participate in the study.

2. Patients: In both study arms, adolescents attending one of the four study YFHS will be included in the study if they:

1. are between the ages of 12-19 years;

2. screen positive for depression;

3. provide informed consent (ages 16 -19) or if their guardian provides informed consent and they provide assent (if ages 12-15).

3. Study centers: must be clinics that have YFHS.

Exclusion Criteria

In both study arms, adolescents will be excluded if they:

1. are unable to participate in treatment due to acute illness; and/or

2. are unable to communicate sufficiently in Portuguese to answer inclusion questions.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Kathryn L. Lovero, PhD

Assistant Professor of Sociomedical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Lovero, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Centro de Saude Alto Mae

Maputo, , Mozambique

Centro de Saude Chamaculo

Maputo, , Mozambique

Centro de Saude Magoanine Tendas

Maputo, , Mozambique

Centro de Saude Primeiro de Maio

Maputo, , Mozambique

Countries

Mozambique

Other Identifiers

K01MH120258

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU3060

Identifier Type: -

Identifier Source: org_study_id