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

NCT07812311 | Active Not Recruiting

• 1 other identifier: 0204-2026
• Study Type: interventional
• Target: 1,213
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression - Major Depressive Disorder

Keywords

group psychotherapy; IPT-G; mental health; Uganda; RCT

Outcome Measures

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).

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

Secondary Outcomes (16)

• Generalized Anxiety Disorder

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

• Male Depression

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

• Stress overload

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

• Disability and functional impairment

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

• Subjective well-being

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

Study Arms (2)

Treatment

EXPERIMENTAL

IPT-G

Behavioral: Group Interpersonal Therapy (IPT-G)

Control

ACTIVE COMPARATOR

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

Behavioral: Enhanced treatment as usual

Interventions

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.

Treatment

Enhanced treatment as usual BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• IDinsight: lead
• StrongMinds: collaborator

Study Sites (1)

StrongMinds Uganda

Kampala, Uganda

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Jeffery McManus, Master's

  IDinsight

  PRINCIPAL INVESTIGATOR

• Victoria Baranov, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

• Molly Naisanga, PhD

  Gulu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

UG (1)