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Evaluating the effects of StrongMinds Community-Based group interpersonal therapy on depression and secondary outcomes in uganda: a cluster randomized controlled trial

NCT ID NCT07812311

NEW Sponsor: IDinsight Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

This study aims to evaluate the impact of the StrongMinds Group Interpersonal Therapy (IPT-G) program on depressive symptoms (primary outcome) and measures related to quality of life, social, economic, educational outcomes, and within-household spillover effects (secondary outcomes). This study is a two-arm, parallel, cluster-randomized controlled trial (RCT) in which villages serve as the unit of randomization. 100 villages across two districts in Uganda, Luuka and Buikwe, have been randomly assigned in equal proportion to one of two conditions: (1) a treatment arm, in which eligible participants receive StrongMinds' 6-week community-based IPT-G program, or (2) a control arm, in which eligible participants receive enhanced-treatment-as-usual (ETAU), involving psychoeducation and referral to a nurse. Primary hypothesis: Participants in villages randomized to receive IPT-G will exhibit a significantly greater reduction in Patient Health Questionnaire-9 (PHQ-9) depression scores at 6 months post-treatment compared to participants in ETAU villages.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,213 people

The number who actually took part.

Started

Jul 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9) at screening, indicating at least moderate depressive symptoms. 2. Are aged 15 and above. 3. Are a permanent resident of the study village. 4. Provide written informed consent (or assent with parental/guardian consent, in case of a non-emancipated minor). Exclusion Criteria: 1. Report active suicidal ideation (assessed via PHQ-9 item 9). Individuals excluded on this basis will be immediately referred for care in accordance with the protocol described in Section 2.10 and Annex H. 2. Are identified as currently experiencing gender-based violence (GBV) requiring immediate safety intervention and referral. 3. Are unable to provide informed consent due to cognitive impairment, severe distress, or other factors as assessed by the research assistant. 4. Have previously participated in a StrongMinds IPT-G group. Individuals excluded due to suicidal ideation or GBV will be referred to appropriate services (see Section 2.10) and will not be enrolled in the study. Individuals with active suicidal ideation will be excluded because group IPT-G cannot provide the individualized monitoring and crisis response that acute suicidality requires.These exclusions are intended to ensure participant safety and do not preclude individuals from receiving StrongMinds services outside the study context.

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Conditions

The condition(s) this trial relates to.

major depressive disorder Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression - major depressive disorder

Contacts and locations

Locations

  • StrongMinds Uganda

    Kampala, Uganda

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