ClinicalTrials.gg
Active, not recruitingNCT07812311Updated Sep 10, 2026

Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda

An interventional study of Group Interpersonal Therapy (IPT-G) and Enhanced treatment as usual in Depression - Major Depressive Disorder, sponsored by IDinsight. Active, not recruiting at 1 site in Uganda. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by IDinsight · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
1,213
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Psychological Well-Being with a site in Uganda — 3 open to participants now, 6 under way, none of them phase 3. Psychological Well-Being · Uganda.

Enrollment
4th of 10
1,213 · median 900
Started
2026
with 3 others
No phase
10 of 10
3 open now
Registered
10th of 10
by date
Lead sponsor
1 of 10
IDinsight

Among the 10 studies in Psychological Well-Being with a site in Uganda, this one is the 4th largest by enrollment, is one of 4 that started in 2026, is one of 10 with no phase, and was the 10th registered.

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

Browse Psychological Well-Being studies →

Open to participants now

3 of the 10 studies in Psychological Well-Being with a site in Uganda are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Uganda have not opened yet or have stopped. Only those recruiting at a site in Uganda →

Who these studies take

Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.

This study: 15 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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.

Read the detailed description

See attached study protocol for more details.

03

Conditions studied

  • Depression - Major Depressive Disorder

Keywords

  • group psychotherapy
  • IPT-G
  • mental health
  • Uganda
  • RCT
04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 (or assent with parental/guardian consent, in case of a non-emancipated minor).

Exclusion criteria

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 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.

Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,213 participants (actual)

Study arms

  • Experimental
    Treatment

    IPT-G

    Behavioral: Group Interpersonal Therapy (IPT-G)

  • Active comparator
    Control

    Enhanced-Treatment-As-Usual (ETAU): psychoeducation and referral to a government nurse

    Behavioral: Enhanced treatment as usual

Interventions

  • BehavioralGroup Interpersonal Therapy (IPT-G)

    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. 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. 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.

  • BehavioralEnhanced treatment as usual

    Eligible participants in the control group receive enhanced-treatment-as-usual (ETAU), involving psychoeducation and referral to a nurse.

06

What researchers measure

Primary outcomes

  1. Depression severity (PHQ-9)

    Score on the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a validated 9-item self-report measure of depression severity over the past two weeks, scored 0 (minimal or no depressive symptoms) to 27 (severe depressive symptoms).

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

Secondary outcomes

  1. Generalized Anxiety Disorder

    GAD-7: A 7-item measure of anxiety severity, rated from 0 (minimal anxiety) to 21 (severe anxiety)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  2. Male Depression

    Male Depression Risk Scale (MDRS-7): A 7-item multidimensional depression rating scale capturing other behaviors associated with depression, rated from 0 (minimal depression) to 28 (severe depression)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  3. Stress overload

    Stress Overload Scale (SOS): A 4-item scale measuring perceived stress and feelings of being overwhelmed, rated from 0 (minimal stress) to 16 (severe stress)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  4. Disability and functional impairment

    World Health Organization 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), rated from 0 (minimal functional impairment) to 48 (severe functional impairment)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  5. Subjective well-being

    Cantril Self-Anchoring Ladder: A single-item measure of subjective well-being, rated from 0 (worst possible life) to 10 (best possible life)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  6. Positive affect well-being

    World Health Organization Well-Being Index (WHO-5): A 5-item positive-affect wellbeing measure on mood, calmness, energy, sleep quality, and daily interest, rated from 0 (very poor well-being) to 25 (very good well-being)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  7. Perceived social support

    Multidimensional Scale of Perceived Social Support (MSPSS) Reduced Scale: A 6-item measure of perceived support from family, friends, and significant others, rated from 6 (very limited social support) to 30 (very strong social support)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  8. Labor market participation (1)

    Labor supply: days worked in the past week

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  9. Household income

    Household monthly income

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  10. Nutrition (1)

    Nutrition: Number of meals consumed in the past 24 hours (self)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  11. Household consumption

    Household consumption: Total value of household consumption (in Ugandan shillings), aggregated from a list of 12 commonly-consumed items.

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  12. Decision-making

    Decision-making: A 9-item scale to measure of indecision and choice avoidance, rated from 9 (very indecisive) to 45 (very decisive)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  13. Labor market participation (2)

    Labor supply: average number of hours worked per day in the previous week

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  14. Self-efficacy

    Self efficacy: A 5-item scale of self-efficacy, rated from 5 (minimal self-efficacy) to 25 (maximum self-efficacy)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  15. Nutrition (2)

    Nutrition: Number of meals consumed in the past 24 hours (average across children in the household)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

  16. Nutrition (3)

    Nutrition: Food insecurity, as measured on the 3-item Household Hunger Scale (HHS), rated from 0 (little or no hunger) to 6 (severe hunger)

    Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention

07

Study locations

1 site
  • StrongMinds Uganda
    Kampala, Uganda
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — All data collected from participants will be anonymized and posted on a public dataverse.

Supporting information: Study protocol

Time frame: IPD will be shared approximately six months after study completion (likely in 2028) and will be available indefinitely.

Access criteria: The anonymized study data will be shared on the Harvard Dataverse.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Apr 2027, 9 months after the start.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 9 months is below that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Sep 10, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Apr 9, 2027
CompletionEst.
Apr 9, 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07812311
Lead sponsor
IDinsight
Collaborators
StrongMinds
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Jul 1, 2026
Primary completion
Apr 9, 2027 (estimated)
Completion
Apr 9, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Jeffery McManus, Master's
principal investigator · IDinsight
Victoria Baranov, PhD
principal investigator · University of Melbourne
Molly Naisanga, PhD
principal investigator · Gulu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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