An interventional study of Group Interpersonal Therapy for Adolescents (IPT-AG) and Treatment as Usual (TAU) in Depression and Adolescent Behavior, sponsored by Columbia University. Completed at 4 sites in Mozambique. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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).
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 95 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Providers:
Patients: In both study arms, adolescents attending one of the four study YFHS will be included in the study if they:
Exclusion Criteria:
In both study arms, adolescents will be excluded if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Treatment as Usual (TAU)
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.
Behavioral: 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.
Adolescents will be administered unstructured psychotherapy in individual sessions with a trained mental health specialist (i.e., psychologist or psychiatric technician).
Also known as: TAU
Change in PHQ-A Score From Baseline to 6 Months Post-intervention
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). The change in PHQ-A score will be reported as a percent change.
Time frame: Baseline, 6 months
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). The total score range is 1 to 14, with a lower score indicating a better outcome. This outcome was only assessed in participants who received the study intervention.
Time frame: 6 months post-intervention
| Milestone | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) |
|---|---|---|
| Started | 83 | 12 |
| Completed | 83 | 12 |
| Not completed | 0 | 0 |
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). The change in PHQ-A score will be reported as a percent change.
| percent change | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) |
|---|---|---|
| Change in PHQ-A Score From Baseline to 6 Months Post-intervention | -35.9 ± 4.52 | -54.0 ± 8.5 |
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). The total score range is 1 to 14, with a lower score indicating a better outcome. This outcome was only assessed in participants who received the study intervention.
| score on a scale | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) |
|---|---|---|
| IPT-AG Fidelity | 1.3 ± 0.56 | — |
Collected over up to 6 months after treatment initiation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interpersonal Therapy for Adolescents (IPT-AG) | 0/83 (0%) | 0/83 (0%) | 20/83 (24.1%) |
| Treatment as Usual (TAU) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) |
|---|---|---|
| Suicidal thoughtsPsychiatric disorders | 20/83 | 1/12 |
| Age, Continuous(years) | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Mean | 17.4 ± 1.5 | 16.1 ± 2.2 | 17.3 ± 1.65 |
| Sex: Female, Male(Participants) | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 83 | 12 | 95 |
| Race (NIH/OMB)(Participants) | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 83 | 12 | 95 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Interpersonal Therapy for Adolescents (IPT-AG) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Mozambique | 83 | 12 | 95 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2023 to primary completion in May 2024, 13 months.
Results were first posted in Feb 2026, 1 year 9 months after primary completion.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 13 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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