NCT06957925

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,598

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 27, 2025

Last Update Submit

April 27, 2025

Conditions

Keywords

actbelongcommitadolescentsUgandaanxietydepressionphysical activitysleep

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire -9

    2 weeks

  • Generalized Anxiety Disorder - 7

    2 weeks

Secondary Outcomes (1)

  • Patient Health Questionnaire -9

    2 weeks

Study Arms (2)

ABC

EXPERIMENTAL
Behavioral: educational

Care as usual

NO INTERVENTION

Interventions

educationalBEHAVIORAL

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.

ABC

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School

Gulu, Uganda

Location

School

Masaka, Uganda

Location

MeSH Terms

Conditions

Anxiety DisordersDeafness, Autosomal Dominant 20DepressionMotor Activity

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masked for group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pilot cluster-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2025

First Posted

May 6, 2025

Study Start

May 12, 2023

Primary Completion

May 12, 2023

Study Completion

May 11, 2024

Last Updated

May 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations