Psychological DistressTHRIVENCT06425523
Transforming Health and Resilience in Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale
A study testing Home Gardening Intervention (HGI) and Self-Help Plus (SH+) in people with Psychological Distress and Malnutrition, Child, run by Uppsala University at 1 site in Uganda.
Trial summary
The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Psychological Distress, Malnutrition, Child, Dietary Deficiency
- What is being tested?
- Home Gardening Intervention (HGI) and Self-Help Plus (SH+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- 1 siteUganda
- Study dates
- 13 Dec 2024to Dec 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psychological distress (score 5 or above on K-6)
- Ability to speak and understand Kiswahili
- Have a child aged 36-59 months
- Availability of plot of land for farming
- Access of water for farming
- Written informed consent to enter the study
Show all 9Show fewer
- Age 36-59 months
- Written parental consent to enter the study
- Assent to enter the study
Who cannot join
- Imminent risk of suicide
- Observable signs of psychosis
- Manic behaviors
- Intellectual disability
- Intellectual disability
- Not living with mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Resilience to Climate Change by Improving Mental Health: Evidence from a Randomized Intervention in Southwestern Uganda
The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups:
- Control group: Mothers will receive Enhanced Usual Care (EUC).
- HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening.
- HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention.
Read more
The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention.
Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups.
The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess children's well-being and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development.
- Conditions
- Psychological Distress, Malnutrition, Child, Dietary Deficiency, Mental Health, Malnutrition
- Being tested
- Home Gardening Intervention (HGI), Self-Help Plus (SH+), Enhanced Usual Care (EUC)
- Keywords
- Self-Help Plus, Home Gardening Intervention, Uganda, Refugee, Nakivale, Mental health, Child development, Food security, Climate change adaptation, Climate smart agriculture, Farming intervention
- Medical subject headings
- Child Nutrition Disorders, Malnutrition, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Gardening Intervention (HGI)Behavioural
The Home Gardening Intervention (HGI) provides refugee participants with agricultural inputs and training (field prep., sowing, water management, pest control, weeding, etc.) through a participatory field school approach with a curriculum derived from best practices in agro-ecology. The program includes active monitoring during a 12-month period. The training involves nutrition education on cooking methods and the importance of dietary diversity using garden produce as well as guidance on surplus management and market support. The overall goal of the intervention is to enable climate-resilient farming for improved food security and dietary diversity that is sustainable long-term.
Self-Help Plus (SH+)Behavioural
Self-Help Plus (SH+) is a 5-session group intervention developed by the WHO and based on Acceptance and Commitment Therapy, delivered by trained local facilitators. It provides tools to manage stress and adversity through pre-recorded audio lessons and a self-help book. Sessions include individual exercises and group discussions.
SH+ aims to decrease psychological distress. It has shown effectiveness among refugees in Uganda and elsewhere.
Enhanced Usual Care (EUC)Behavioural
The Enhanced Usual Care (EUC) control condition involves a single 15-minute psychoeducation session providing information on managing overthinking and utilizing available mental health services in the settlement. These services include psychosocial support from community health workers and clinical mental health services (counseling and medications) provided weekly at local primary care centers by a visiting team.
| Study group | Role | What they receive |
|---|---|---|
| EUC | Active comparator | Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care (EUC) |
| HGI | Experimental | Home Gardening Intervention Receives: Behavioral: Home Gardening Intervention (HGI); Behavioral: Enhanced Usual Care (EUC) |
| SH+/HGI | Experimental | Self-Help Plus in combination with Home Gardening Intervention Receives: Behavioral: Home Gardening Intervention (HGI); Behavioral: Self-Help Plus (SH+); Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food insecurity
Food insecurity will be assessed using the Food Insecurity Experience Scale (FIES). The FIES was developed by the FAO, and consists of 8 questions regarding the availability of sufficient food in the past thirty days. The questions form a scale calibrated against a global reference from the 2014-2016 Gallup World Poll for comparability across countries. Responses are analyzed as a scale using Item Response Theory (IRT) models, ensuring comparability of food insecurity prevalence rates.
Measured: 12 months
Secondary outcomes (3)
Dietary diversity
Dietary diversity will be assessed using the Household Dietary Diversity Score (HDDS). The HDDS is a measure of food consumption that reflects a household's access to a variety of foods. It's based on households' self-reporting of the 12 food groups consumed in the previous 24 hours.
Measured: 12 months
Child malnutrition
Child malnutrition will be assessed using the Height-for-Age Z-score (HAZ). The HAZ is a standard statistical measurement that represents how a child's height compares to a reference population of the same age and sex. It's used to assess long-term nutritional status and can indicate chronic malnutrition or stunting. A HAZ score below -2 is considered stunted, indicating that the child is significantly shorter than the average height for their age. A score above +2 would suggest the child is taller than the average height for their age.
Measured: 12 months
Psychological distress
Psychological distress will be measured using the Kessler Psychological Distress Scale (K6). The K6 is a concise tool used to screen for psychological distress. It assesses general psychological distress through six questions that inquire about symptoms of depression and anxiety experienced in the past month. Each of the six questions is scored from 0 (none of the time) to 4 (all of the time), providing a total score range from 0 to 24. Higher scores indicate greater psychological distress.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start13 Dec 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Model description
- Three-arm, parallel-group, 1:1:1 allocation, superiority, cluster-randomized controlled trial (cRCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Vivo international e.V., Bielefeld University, Kabale University, University of Turku, Max Planck Institute for Research on Collective Goods, University of North Carolina, Charlotte
- Responsible party
- Sponsor
- Investigators
- Jonathan Hall, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425523
- Sponsor's protocol ID
- NAK-SH/HGI-2024
- Other IDs
- 2022-01573_Formas
- Acronym
- THRIVE
- Status last verified
- Jan 2025
- First submitted
- 17 May 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.
PubMed 31981556Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8.
PubMed 38641632Hall J, Ainamani HE, Vassiliou PTB, Doring S, Gredeback G, Peltonen K, Scharpf F, Sen U, Sutter M, Walsh JI, Hecker T. Combining mental health and climate-smart agricultural interventions to improve food security in humanitarian settings: study protocol for the THRIVE cluster-randomized controlled trial with mothers in Nakivale refugee settlement, Uganda. Trials. 2025 Sep 1;26(1):331. doi: 10.1186/s13063-025-09042-y.
PubMed 40890859
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Resilience to Climate Change by Improving Mental Health: Evidence from a Randomized Intervention in Southwestern Uganda
- ClinicalTrials.gov ID
- NCT06425523
- Acronym / sponsor ID
- THRIVE / NAK-SH/HGI-2024
- Conditions
- Psychological Distress, Malnutrition, Child, Dietary Deficiency, Mental Health, Malnutrition
- Keywords
- Self-Help Plus, Home Gardening Intervention, Uganda, Refugee, Nakivale, Mental health, Child development, Food security
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 904 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Vivo international e.V., Bielefeld University, Kabale University, University of Turku, Max Planck Institute for Research on Collective Goods, University of North Carolina, Charlotte
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2024 (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.
The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups:
- Control group: Mothers will receive Enhanced Usual Care (EUC).
- HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening.
- HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention.
The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention.
Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups.
The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess children's well-being and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group, 1:1:1 allocation, superiority, cluster-randomized controlled trial (cRCT)
| Arm | Type | Receives |
|---|---|---|
| EUC | Active comparator | Behavioral: Enhanced Usual Care (EUC)Enhanced Usual Care |
| HGI | Experimental | Behavioral: Home Gardening Intervention (HGI), Behavioral: Enhanced Usual Care (EUC)Home Gardening Intervention |
| SH+/HGI | Experimental | Behavioral: Home Gardening Intervention (HGI), Behavioral: Self-Help Plus (SH+), Behavioral: Enhanced Usual Care (EUC)Self-Help Plus in combination with Home Gardening Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Psychological distress (score 5 or above on K-6)
- Ability to speak and understand Kiswahili
- Have a child aged 36-59 months
- Availability of plot of land for farming
- Access of water for farming
Key exclusion criteria (6 listed)
- Imminent risk of suicide
- Observable signs of psychosis
- Manic behaviors
- Intellectual disability
- Intellectual disability
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 |
|---|---|---|
| Home Gardening Intervention (HGI)The Home Gardening Intervention (HGI) provides refugee participants with agricultural inputs and training (field prep., sowing, water management, pest control, weeding, etc.) through a participatory field school approach with a curriculum derived from best practices in agro-ecology. The program includes active monitoring during a 12-month period. The training involves nutrition education on cooking methods and the importance of dietary diversity using garden produce as well as guidance on surplus management and market support. The overall goal of the intervention is to enable climate-resilient farming for improved food security and dietary diversity that is sustainable long-term. | Behavioural | HGI, SH+/HGI |
| Self-Help Plus (SH+)Self-Help Plus (SH+) is a 5-session group intervention developed by the WHO and based on Acceptance and Commitment Therapy, delivered by trained local facilitators. It provides tools to manage stress and adversity through pre-recorded audio lessons and a self-help book. Sessions include individual exercises and group discussions. SH+ aims to decrease psychological distress. It has shown effectiveness among refugees in Uganda and elsewhere. | Behavioural | SH+/HGI |
| Enhanced Usual Care (EUC)The Enhanced Usual Care (EUC) control condition involves a single 15-minute psychoeducation session providing information on managing overthinking and utilizing available mental health services in the settlement. These services include psychosocial support from community health workers and clinical mental health services (counseling and medications) provided weekly at local primary care centers by a visiting team. | Behavioural | EUC, HGI, SH+/HGI |
Primary outcome
Food insecurity
Time frame: 12 months
Food insecurity will be assessed using the Food Insecurity Experience Scale (FIES). The FIES was developed by the FAO, and consists of 8 questions regarding the availability of sufficient food in the past thirty days. The questions form a scale calibrated against a global reference from the 2014-2016 Gallup World Poll for comparability across countries. Responses are analyzed as a scale using Item Response Theory (IRT) models, ensuring comparability of food insecurity prevalence rates.
3 secondary outcomes
Dietary diversity
Time frame: 12 months
Child malnutrition
Time frame: 12 months
Psychological distress
Time frame: 12 months
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 28 Jan 2025.
- Background: PubMed 31981556Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.
- Background: PubMed 38641632Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8.
- Derived from this study: PubMed 40890859Hall J, Ainamani HE, Vassiliou PTB, Doring S, Gredeback G, Peltonen K, Scharpf F, Sen U, Sutter M, Walsh JI, Hecker T. Combining mental health and climate-smart agricultural interventions to improve food security in humanitarian settings: study protocol for the THRIVE cluster-randomized controlled trial with mothers in Nakivale refugee settlement, Uganda. Trials. 2025 Sep 1;26(1):331. doi: 10.1186/s13063-025-09042-y.
- Individual participant dataSharing planned: No
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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.
Jonathan Hall, PhD principal investigator
Uppsala 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 Home Gardening Intervention (HGI) and Self-Help Plus (SH+) in people with Psychological Distress and Malnutrition, Child, run by Uppsala University 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 9 inclusion and 6 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 28 Jan 2025. 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?
Food insecurity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425523, which also lists 3 linked publications.
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 28 Jan 2025.