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NCT Number: NCT07812311

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Depression - Major Depressive Disorder Behavior Personal Satisfaction Psychological Well-Being

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

StrongMinds Uganda

Kampala, Uganda

About this study

See attached study protocol for more details.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • Are unable to provide informed consent due to cognitive impairment, severe distress, or other factors as assessed by the research assistant.
  • 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.

Treatment and study plan

Group Interpersonal Therapy (IPT-G)

Behavioral

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.

Enhanced Treatment as Usual

Behavioral

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

Primary outcomes

  1. Depression severity (PHQ-9)

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

    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).

Secondary outcomes

  1. Generalized Anxiety Disorder

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

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

  2. Male Depression

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

    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)

  3. Stress overload

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

    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)

  4. Disability and 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

    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)

  5. Subjective 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

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

  6. Positive affect 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

    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)

  7. Perceived 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

    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)

  8. Labor market participation (1)

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

    Labor supply: days worked in the past week

  9. Household income

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

    Household monthly income

  10. Nutrition (1)

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

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

  11. Household consumption

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

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

  12. Decision-making

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

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

  13. Labor market participation (2)

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

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

  14. 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

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

  15. Nutrition (2)

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

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

  16. Nutrition (3)

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

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

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

IDinsight

Other

Collaborators

  • StrongMinds

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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