Depression - Major Depressive DisorderNCT07812311
Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda
A study testing Group Interpersonal Therapy (IPT-G) and Enhanced treatment as usual in people with Depression - Major Depressive Disorder, run by IDinsight at 1 site in Uganda.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Group Interpersonal Therapy (IPT-G) and Enhanced treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,213 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jul 2026to 9 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda: A Cluster Randomized Controlled Trial
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.
Read the detailed description
See attached study protocol for more details.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Group Interpersonal Therapy (IPT-G), Enhanced treatment as usual
- Keywords
- group psychotherapy, IPT-G, mental health, Uganda, RCT
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Interpersonal Therapy (IPT-G)Behavioural
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 usualBehavioural
Eligible participants in the control group receive enhanced-treatment-as-usual (ETAU), involving psychoeducation and referral to a nurse.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | IPT-G Receives: Behavioral: Group Interpersonal Therapy (IPT-G) |
| Control | Active comparator | Enhanced-Treatment-As-Usual (ETAU): psychoeducation and referral to a government nurse Receives: Behavioral: Enhanced treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
GAD-7: A 7-item measure of anxiety severity, rated from 0 (minimal anxiety) to 21 (severe anxiety)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Male Depression
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)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Stress overload
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)
Measured: 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
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)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Subjective well-being
Cantril Self-Anchoring Ladder: A single-item measure of subjective well-being, rated from 0 (worst possible life) to 10 (best possible life)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Positive affect well-being
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)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Perceived social support
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)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Labor market participation (1)
Labor supply: days worked in the past week
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Household income
Household monthly income
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Nutrition (1)
Nutrition: Number of meals consumed in the past 24 hours (self)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Household consumption
Household consumption: Total value of household consumption (in Ugandan shillings), aggregated from a list of 12 commonly-consumed items.
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Decision-making
Decision-making: A 9-item scale to measure of indecision and choice avoidance, rated from 9 (very indecisive) to 45 (very decisive)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Labor market participation (2)
Labor supply: average number of hours worked per day in the previous week
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Self-efficacy
Self efficacy: A 5-item scale of self-efficacy, rated from 5 (minimal self-efficacy) to 25 (maximum self-efficacy)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Nutrition (2)
Nutrition: Number of meals consumed in the past 24 hours (average across children in the household)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Nutrition (3)
Nutrition: Food insecurity, as measured on the 3-item Household Hunger Scale (HHS), rated from 0 (little or no hunger) to 6 (severe hunger)
Measured: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Jul 2026
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDinsight
- Sponsor type
- University, hospital or other
- Collaborators
- StrongMinds
- Responsible party
- Sponsor
- Investigators
- Jeffery McManus, Master's, Principal investigator, IDinsightVictoria Baranov, PhD, Principal investigator, University of MelbourneMolly Naisanga, PhD, Principal investigator, Gulu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812311
- Sponsor's protocol ID
- 0204-2026
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected from participants will be anonymized and posted on a public dataverse.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of StrongMinds Community-Based Group Interpersonal Therapy on Depression and Secondary Outcomes in Uganda: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07812311
- Acronym / sponsor ID
- 0204-2026
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- group psychotherapy, IPT-G, mental health, Uganda, RCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,213 participants (actual)
- Lead sponsor
- IDinsightUniversity, hospital or other
- Collaborators
- StrongMinds
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Group Interpersonal Therapy (IPT-G)IPT-G |
| Control | Active comparator | Behavioral: Enhanced treatment as usualEnhanced-Treatment-As-Usual (ETAU): psychoeducation and referral to a government nurse |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 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. | Behavioural | Treatment |
| Enhanced treatment as usualEligible participants in the control group receive enhanced-treatment-as-usual (ETAU), involving psychoeducation and referral to a nurse. | Behavioural | Control |
Primary outcome
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).
16 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 (3)
Time frame: Enrollment (pre-intervention), 2-weeks post-intervention, 6-months post-intervention, (potentially) 12-months post-intervention, (potentially) 24-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. All data collected from participants will be anonymized and posted on a public dataverse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery McManus, Master's principal investigator
IDinsight
Victoria Baranov, PhD principal investigator
University of Melbourne
Molly Naisanga, PhD principal investigator
Gulu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Interpersonal Therapy (IPT-G) and Enhanced treatment as usual in people with Depression - Major Depressive Disorder, run by IDinsight at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.