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

NCT07812311

Active Not RecruitingNA

Sponsor: IDinsight

Conditions: Depression - Major Depressive Disorder

Interventions: Group Interpersonal Therapy (IPT-G), Enhanced treatment as usual

Countries: 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.

Eligibility overview

Sex: ALL

Age: 15 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

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 informed consent 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.

Locations (1)

Kampala, Uganda