NCT07812311Active, not recruiting
Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda
Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda: A Cluster Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1213 (actual)
- First submitted
- 26 Aug 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 9 Apr 2027
- Lead sponsor
- IDinsight
- Diseases
- Depression
- NCT number
- NCT07812311
What you commit to
- Study type: Interventional
- Participants enrolled: 1213
- From 1 Jul 2026 to the primary completion date, 9 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Are unable to provide informed consent due to cognitive impairment, severe distress, or other factors as assessed by the research assistant.
Other
- 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.
- Are identified as currently experiencing gender-based violence (GBV) requiring immediate safety intervention and referral.
Who the study is looking for
- Score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9) at screening, indicating at least moderate depressive symptoms.
- Are aged 15 and above.
- Are a permanent resident of the study village.
- Provide written informed consent (or assent with parental/guardian consent, in case of a non-emancipated minor).
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| StrongMinds Uganda Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.