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Adolescent Depression Screening and Treatment in Mozambican Primary Care

Primary Purpose

Depression, Adolescent Behavior

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Mozambique
Study Type
Interventional
Intervention
Group Interpersonal Therapy for Adolescents (IPT-AG)
Treatment as Usual (TAU)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring adolescent depression

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Saude Alto Mae
  • Centro de Saude Chamaculo
  • Centro de Saude Magoanine Tendas
  • Centro de Saude Primeiro de Maio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TAU

IPT-AG

Arm Description

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 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.

Outcomes

Primary Outcome Measures

PHQ-A results
The Patient Health Questionnaire (PHQ)-A is a 9-item severity measure of depression for adolescents adapted from the PHQ-9. Questions ask how often an adolescent has been bothered by different depression symptoms in the past week, and responses of "not at all," "several days," "more than half the days," and "nearly every day" are given scores of 0 to 3. A total score is calculated by summing the value of all items and ranges from 0 (better outcome) to 27 (worse outcome).
IPT-AG Fidelity
The Group IPT-AG Fidelity Checklist is a 14-item scale that measures provider fidelity to group interpersonal therapy for adolescents. Providers are scored for superior (1), satisfactory (2), or needs improvement (3) adherence to each item on the checklist, which each represent and essential element of treatment (e.g., gives hope that depression is treatable, links depression to interpersonal problems). The score of the 14-items is averaged to compute the IPT-AG Fidelity rating (1=superior, 2=satisfactory, 3=needs improvement), with 1 indicating a better outcome.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
July 14, 2023
Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05476237
Brief Title
Adolescent Depression Screening and Treatment in Mozambican Primary Care
Official Title
Pilot Implementation of Depression Screening and Treatment for Adolescents in Mozambican Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Adolescent Behavior
Keywords
adolescent depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IPT-AG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Interpersonal Therapy for Adolescents (IPT-AG)
Intervention Description
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
Intervention Name(s)
Treatment as Usual (TAU)
Other Intervention Name(s)
TAU
Intervention Description
Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).
Primary Outcome Measure Information:
Title
PHQ-A results
Description
The Patient Health Questionnaire (PHQ)-A is a 9-item severity measure of depression for adolescents adapted from the PHQ-9. Questions ask how often an adolescent has been bothered by different depression symptoms in the past week, and responses of "not at all," "several days," "more than half the days," and "nearly every day" are given scores of 0 to 3. A total score is calculated by summing the value of all items and ranges from 0 (better outcome) to 27 (worse outcome).
Time Frame
6 months
Title
IPT-AG Fidelity
Description
The Group IPT-AG Fidelity Checklist is a 14-item scale that measures provider fidelity to group interpersonal therapy for adolescents. Providers are scored for superior (1), satisfactory (2), or needs improvement (3) adherence to each item on the checklist, which each represent and essential element of treatment (e.g., gives hope that depression is treatable, links depression to interpersonal problems). The score of the 14-items is averaged to compute the IPT-AG Fidelity rating (1=superior, 2=satisfactory, 3=needs improvement), with 1 indicating a better outcome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Providers: 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. 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. Patients: In both study arms, adolescents attending one of the four study YFHS will be included in the study if they: are between the ages of 12-19 years; screen positive for depression; provide informed consent (ages 16 -19) or if their guardian provides informed consent and they provide assent (if ages 12-15). Study centers: must be clinics that have YFHS. Exclusion Criteria: In both study arms, adolescents will be excluded if they: are unable to participate in treatment due to acute illness; and/or are unable to communicate sufficiently in Portuguese to answer inclusion questions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Lovero, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Saude Alto Mae
City
Maputo
Country
Mozambique
Facility Name
Centro de Saude Chamaculo
City
Maputo
Country
Mozambique
Facility Name
Centro de Saude Magoanine Tendas
City
Maputo
Country
Mozambique
Facility Name
Centro de Saude Primeiro de Maio
City
Maputo
Country
Mozambique

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adolescent Depression Screening and Treatment in Mozambican Primary Care

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