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

N/AActive Not RecruitingNCT07812311

IDinsight1,213 enrolled

Overview

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.

See attached study protocol for more details.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,213

Conditions

Depression - Major Depressive Disorder

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.

Enhanced treatment as usualBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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)

StrongMinds Uganda

Kampala, Uganda

Outcomes

Primary Outcomes

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).