Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda: A Cluster Randomized Controlled Trial

Last registered on August 31, 2026

Pre-Trial

Trial Information

General Information

Title
Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda: A Cluster Randomized Controlled Trial
RCT ID
AEARCTR-0019492
Initial registration date
August 27, 2026

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
August 31, 2026, 8:36 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
IDinsight

Other Primary Investigator(s)

PI Affiliation
StrongMinds
PI Affiliation
University of Melbourne
PI Affiliation
StrongMinds
PI Affiliation
Gulu University
PI Affiliation
StrongMinds
PI Affiliation
Ministry of Health, Uganda
PI Affiliation
IDinsight
PI Affiliation
IDinsight
PI Affiliation
IDinsight
PI Affiliation
StrongMinds
PI Affiliation
IDinsight
PI Affiliation
IDinsight

Additional Trial Information

Status
On going
Start date
2026-07-01
End date
2027-05-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Depression is a significant public health concern in low- and middle-income countries, with high prevalence rates and limited access to mental health care due to resource constraints, stigma, and a shortage of trained professionals. Group Interpersonal Therapy (IPT-G) has been identified as an effective, scalable intervention for addressing depression in low-resource settings. However, most evaluations of IPT-G have been conducted in controlled research settings or with longer intervention durations, leaving a gap in understanding its effectiveness when implemented as part of a real-world program. The StrongMinds model, a six-week adaptation of IPT-G designed for community settings, offers a promising, more accessible alternative to the standard eight-week model. The StrongMinds model is designed to be scalable within government health systems.

This study aims to evaluate the impact of the StrongMinds IPT-G model on depressive symptoms (primary outcome) and measures related to quality of life, social, economic, educational outcomes, and within-household spillover effects (secondary outcomes). A randomized controlled trial (RCT) will be conducted in Luuka and Buikwe districts in Uganda. The research team will sample 40 villages in Luuka and 60 villages in Buikwe (100 villages total). To minimize contamination and ethical concerns regarding offering treatment to some eligible individuals within a village and not to others, the study will randomly allocate half of the villages in each district to the intervention cluster and half to the control cluster: 20 villages to intervention and 20 to control in Luuka, and 30 villages to intervention and 30 to control in Buikwe. Eligible participants from villages will be pre-screened using the PHQ-4 by StrongMinds program staff and then assessed using the PHQ-9 by research assistants. Those who score 10 or higher on the PHQ-9 will be invited to enroll in the study. Participants from the intervention villages will receive 6-week IPT-G immediately. Participants from the control villages will receive Enhanced Treatment as Usual (ETAU), involving psychoeducation and referral to a Psychiatric nurse.

Research assistants will obtain informed consent and administer baseline, two-week post-treatment, and follow-ups over time (six-month, 12-month, and 24-month post-treatment) surveys. During follow-up rounds post treatment, surveys will be conducted with two non-participant household members, one adolescent and one adult per enrolled household to measure spillover.

The primary outcome will be the reduction in depressive symptoms measured by the PHQ-9. Secondary outcomes will include Anxiety (GAD-7), Externalization of Depression (MDRS-7) Functioning (WHODAS), Subjective Well-being (Cantril Ladder, WHO-5), Social Support (MSPSS), Perceived stress (SOS-4), Nutrition and Food security, Economic (Labor supply/Income), and Consumption measures.

The study is expected to provide evidence on the effectiveness of the StrongMinds’ model in reducing depression in a real-world program setting. Findings will inform the scalability and integration of IPT-G into community-based mental health programs and national health policies in Uganda and similar low-resource settings. By being the first rigorous evaluation of a six-week IPT-G model in a programmatic setting, this study will fill a critical gap in the evidence base for community-based mental health interventions. The results could contribute to efforts to scale up mental health services and improve access to effective depression treatment in Uganda and other LMICs.
External Link(s)

Registration Citation

Citation
Atuhumuza, Elly et al. 2026. "Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda: A Cluster Randomized Controlled Trial." AEA RCT Registry. August 31. https://doi.org/10.1257/rct.19492-1.0
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Experimental Details

Interventions

Intervention(s)
Group Interpersonal Therapy (IPT-G) has emerged as one of the most promising approaches for addressing depression at scale in resource-constrained settings. IPT-G is a structured, time-limited psychotherapy that focuses on resolving interpersonal difficulties such as grief, role disputes, role transitions, and social isolation. These difficulties are causally linked to the onset and maintenance of depressive episodes. A seminal cluster-randomized trial in rural Uganda demonstrated that IPT-G delivered by trained lay health workers produced large, clinically significant reductions in depressive symptoms compared with a control condition, with effects sustained at 6 months post-treatment (Bolton et al., 2003; Bass et al., 2018). Subsequent studies in Uganda and other LMIC settings have replicated these findings, confirming that task-shifting IPT-G delivery to community health workers is both feasible and effective (Verdeli et al., 2003; Mutamba et al., 2018; Lewandowski et al., 2016).

StrongMinds implements an adapted version of IPT-G tailored to the Ugandan context. It involves a six-week program where trained lay workers facilitate weekly group therapy sessions under supervision of trained staff. Preliminary evaluations suggest that the model not only reduces depressive symptoms but also delivers secondary benefits, such as enhanced labour supply and improved subjective well-being. The intervention's community-based nature allows it to address cultural and logistical barriers to mental health care, fostering greater accessibility and sustainability.

In this RCT, we are assessing delivery of IPT-G to four target groups: adult women, adult men, adolescent males, and adolescent females.
Intervention Start Date
2026-07-20
Intervention End Date
2026-09-11

Primary Outcomes

Primary Outcomes (end points)
Depression severity, as measured by the Patient Health Questionnaire-9 (PHQ-9)
Primary Outcomes (explanation)
The PHQ-9 is a validated 9-item self-report measure of depression severity over the past two weeks, scored 0–27.

Secondary Outcomes

Secondary Outcomes (end points)
Generalized anxiety disorder, male depression risk, stress overload, functional impairment, subjective well-being, positive affect well-being, social support, labor supply, income, household consumption and expenditure, nutrition, decision-making, self-efficacy
Secondary Outcomes (explanation)
- Generalized Anxiety Disorder-7 (GAD-7): A 7-item measure of anxiety severity (0–21).
- Male Depression Risk Scale (MDRS-7): A 7-item multidimensional depression rating scale capturing other behaviors associated with depression.
- Stress Overload Scale (SOS): A 4-item scale measuring perceived stress and feelings of being overwhelmed.
- WHO Disability Assessment Schedule (WHODAS 2.0, 12-item): A measure of functional impairment across six domains (cognition, mobility, self-care, getting along, life activities, participation).
- Cantril Self-Anchoring Ladder: A single-item measure of subjective well-being (0–10).
- WHO-5 Well-Being Index: A 5-item positive-affect wellbeing measure on mood, calmness, energy, sleep quality, and daily interest.
- Multidimensional Scale of Perceived Social Support (MSPSS): A measure of perceived support from family, friends, and significant others (1–7).
- Labor supply (days worked in the past week, hours worked yesterday)
- monthly income
- Consumption: As part of a cross-country methodological learning agenda on efficient consumption measurement, a randomly selected sub-sample of participants will, receive an extended (~170-item) consumption module at the 2-week and 6-month follow-ups.
- Nutrition: Number of meals consumed in the past 24 hours (self and children), food insecurity.
- Decision-making and self efficacy: A measure of indecision and choice avoidance and self efficacy.

Experimental Design

Experimental Design
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 Group Interpersonal Therapy (IPT-G), or (2) a control arm, in which eligible participants receive ETAU, involving psychoeducation and referral to a nurse. Within each district, villages were selected and randomized in equal proportion to treatment and control: 40 villages in Luuka (20 treatment, 20 control) and 60 villages in Buikwe (30 treatment, 30 control). The villages will further be stratified by four target groups: Adult males, adult females, out of school adolescent-boys and out-of-school adolescent-girls. Within each village, we randomly selected a subset of approximately 12 eligible participants to enroll, for a total of 1,213 participants enrolled in the study at baseline. More details on eligibility, screening, and enrollment are available in the attached protocol.

Participants in control villages will receive a brief sensitization session about depression and a referral to the nearest government health facility nurse. This comparator was chosen over a pure waitlist design on both ethical and methodological grounds. Ethically, it ensures all study participants receive a minimum level of support. The ETAU condition also guards against nocebo effects in the control group where, receiving no support can adversely impact the control group participants.

At each follow-up wave, an additional sample of up to two non-participant members per enrolled household will be sampled to measure spillover effects. Wherever available, the non-participant household members will be stratified into adolescents (aged 16 to 18) and adults (aged 18+) and a member will be selected randomly from both stratas. This spillover sample will comprise approximately 2,426 additional individuals.
Experimental Design Details
Not available
Randomization Method
tratified random assignment was conducted using Stata/MP v18.0
Randomization Unit
Village
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
100 villages (50 T, 50 C)
Sample size: planned number of observations
Main sample: 1,213 individuals enrolled in the study at baseline (~12 per village) Spillover sample: 2,426 individuals from the 1,213 main participant households (2 per household)
Sample size (or number of clusters) by treatment arms
Main sample: Control: 607 individuals in 50 villages; Treatment: 606 individuals in 50 villages
Spillover sample: Control: 1,214 individuals in 50 villages; Treatment: 1,212 individuals in 50 villages.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Based on the power calculations using data from a pilot RCT conducted by StrongMinds to estimate parameters (including ICC, and baseline-endline correlation), with 100 villages and approximately 10 respondents per village (assuming attrition), the minimum detectable effect size (MDES) for PHQ-9 at 6 months post-treatment is approximately 0.30 standard deviation units. This is smaller than the effect observed in the pilot (SES = 0.9), indicating that the study is well-powered to detect the primary treatment effect in the whole sample and in various subgroups (baseline depression severity, gender, age, etc.).
IRB

Institutional Review Boards (IRBs)

IRB Name
Mildmay Uganda Research Ethics Committee (MUREC)
IRB Approval Date
2026-05-05
IRB Approval Number
0204-2026
Analysis Plan

Analysis Plan Documents

[External] StrongMinds_RCT_Pre-Registration_26Aug2026

MD5: b3bc666e1c6fad93e7d4868d7044731a

SHA1: 51eaf8cc628d4be78fc83ea7dc069a3b1e78aa56

Uploaded At: August 27, 2026