AnxietyNCT06957925
ABC School Intervention Among Ugandan Adolescents
A study testing educational in people with Anxiety and Depression Disorders, run by KU Leuven at 2 sites in Uganda.
Trial summary
Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Anxiety, Depression Disorders
- What is being tested?
- educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,598 participants
- Where
- 2 sitesUganda
- Study dates
- 12 May 2023to 11 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All students aged 14 to 17 years in the four schools were screened for depression and anxiety using the Patient Health Questionnaire - 9 (PHQ-9) (Spitzer et al., 1999) and Generalized Anxiety Disorder - 7 (GAD-7) (Spitzer et al., 2006) as part of school health screening service embedded within the study.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Cultural-sensitive Act-Belong-Commit-based School Intervention Reduces the Burden of Anxiety and Depression in Adolescents: a Pilot Cluster-randomized Trial From Uganda
Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among Ugandan adolescents attending secondary school. Adolescents from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led ACT intervention or a care-as-usual control. Anxiety (GAD-7) and depression (PHQ-9-A) were measured at baseline and immediately post-intervention. Childhood trauma (CTQ-SF), self-reported health, wealth, and food security were assessed at baseline. Linear mixed modeling was used to evaluate intervention effects.
Read the detailed description
Introduction: Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. However, randomized controlled trials tailored to cultural and contextual factors are scarce. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among Ugandan adolescents attending secondary school.
Methods: A total of 2,598 adolescents (1,295 intervention; 1,303 control; 1,199 boys [46.1%]; mean age 16.3 ± 1.0 years) from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led ACT intervention or a care-as-usual control. Anxiety (GAD-7) and depression (PHQ-9-A) were measured at baseline and immediately post-intervention. Childhood trauma (CTQ-SF), self-reported health, wealth, and food security were assessed at baseline. Linear mixed modeling was used to evaluate intervention effects.
- Conditions
- Anxiety, Depression Disorders
- Being tested
- educational
- Keywords
- act, belong, commit, adolescents, Uganda, anxiety, depression, physical activity, sleep
- Medical subject headings
- Anxiety Disorders, Deafness, Autosomal Dominant 20, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationalBehavioural
Teachers were provided with a manual that could be implemented in a flexible way adapted to the local context of the school consisting of six sessions. The manual assisted teachers to prepare students for success in understanding what is a good mental health (session 1), how to optimize and maintain good mental health, with a particular focus on being mentally, spiritually, socially and physically active including coping with stressors via breathing exercises and progressive muscle relaxation techniques (session 2), physical activity participation (session 3) and sleep hygiene measures (session 4), the importance of belongingness and commitment (session 5), and how to seek support including peer support, community engagement and existing local services (session 6). The first 6 sessions were facilitated by the teacher, and the next 6 by peers.
| Study group | Role | What they receive |
|---|---|---|
| ABC | Experimental | Not described Receives: Behavioral: educational |
| Care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire -9
Measured: 2 weeks
Generalized Anxiety Disorder - 7
Measured: 2 weeks
Secondary outcomes (1)
Patient Health Questionnaire -9
Item 9: suicidal ideation
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start12 May 2023
- Primary completion12 May 2023
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Model description
- pilot cluster-randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davy Vancampfort, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957925
- Sponsor's protocol ID
- MUREC 0501-2023
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cultural-sensitive Act-Belong-Commit-based School Intervention Reduces the Burden of Anxiety and Depression in Adolescents: a Pilot Cluster-randomized Trial From Uganda
- ClinicalTrials.gov ID
- NCT06957925
- Acronym / sponsor ID
- MUREC 0501-2023
- Conditions
- Anxiety, Depression Disorders
- Keywords
- act, belong, commit, adolescents, Uganda, anxiety, depression, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,598 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 6 May 2025 (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.
Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among Ugandan adolescents attending secondary school. Adolescents from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led ACT intervention or a care-as-usual control. Anxiety (GAD-7) and depression (PHQ-9-A) were measured at baseline and immediately post-intervention. Childhood trauma (CTQ-SF), self-reported health, wealth, and food security were assessed at baseline. Linear mixed modeling was used to evaluate intervention effects.
Detailed description
Introduction: Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. However, randomized controlled trials tailored to cultural and contextual factors are scarce. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among Ugandan adolescents attending secondary school.
Methods: A total of 2,598 adolescents (1,295 intervention; 1,303 control; 1,199 boys [46.1%]; mean age 16.3 ± 1.0 years) from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led ACT intervention or a care-as-usual control. Anxiety (GAD-7) and depression (PHQ-9-A) were measured at baseline and immediately post-intervention. Childhood trauma (CTQ-SF), self-reported health, wealth, and food security were assessed at baseline. Linear mixed modeling was used to evaluate intervention effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pilot cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| ABC | Experimental | Behavioral: educational |
| Care as usual | No intervention | – |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students aged 14 to 17 years in the four schools were screened for depression and anxiety using the Patient Health Questionnaire - 9 (PHQ-9) (Spitzer et al., 1999) and Generalized Anxiety Disorder - 7 (GAD-7) (Spitzer et al., 2006) as part of school health screening service embedded within the study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| educationalTeachers were provided with a manual that could be implemented in a flexible way adapted to the local context of the school consisting of six sessions. The manual assisted teachers to prepare students for success in understanding what is a good mental health (session 1), how to optimize and maintain good mental health, with a particular focus on being mentally, spiritually, socially and physically active including coping with stressors via breathing exercises and progressive muscle relaxation techniques (session 2), physical activity participation (session 3) and sleep hygiene measures (session 4), the importance of belongingness and commitment (session 5), and how to seek support including peer support, community engagement and existing local services (session 6). The first 6 sessions were facilitated by the teacher, and the next 6 by peers. | Behavioural | ABC |
Primary outcome
Patient Health Questionnaire -9
Time frame: 2 weeks
Generalized Anxiety Disorder - 7
Time frame: 2 weeks
1 secondary outcome
Patient Health Questionnaire -9
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational in people with Anxiety and Depression Disorders, run by KU Leuven at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Health Questionnaire -9 (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 6 May 2025.