Depression - Major Depressive Disorder
Conditions
Keywords
group psychotherapy, IPT-G, mental health, Uganda, RCT
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.
Detailed description
See attached study protocol for more details.
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.
Sponsors
IDinsight
StrongMinds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity (PHQ-9) | 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
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder | 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) |
| Male Depression | 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) |
| Stress overload | 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) |
| 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 | 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) |
| Subjective well-being | 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) |
| Positive affect well-being | 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) |
| Perceived social support | 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) |
| Labor market participation (1) | 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 |
| Household income | Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention | Household monthly income |
| Nutrition (1) | 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) |
| Household consumption | 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. |
| Decision-making | 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) |
| Labor market participation (2) | 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 |
| Self-efficacy | 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) |
| Nutrition (2) | 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) |
| Nutrition (3) | 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) |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORJeffery McManus, Master's
IDinsight
PRINCIPAL_INVESTIGATORVictoria Baranov, PhD
University of Melbourne
PRINCIPAL_INVESTIGATORMolly Naisanga, PhD
Gulu University
Outcome results
None listed