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Clinical Trials/NCT06957925
NCT06957925CompletedNot Applicable

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

KU Leuven2 sites in 1 country2,598 target enrollmentStarted: May 12, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
KU Leuven
Enrollment
2,598
Locations
2
Primary Endpoint
Patient Health Questionnaire -9

Study Overview

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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Masked for group allocation

Eligibility Criteria

Ages
14 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Care as usual

No Intervention

ABC

Experimental

Intervention: educational (Behavioral)

Outcomes

Primary Outcomes

Patient Health Questionnaire -9

Time Frame: 2 weeks

Generalized Anxiety Disorder - 7

Time Frame: 2 weeks

Secondary Outcomes

  • Patient Health Questionnaire -9(2 weeks)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Davy Vancampfort

Professor

KU Leuven

Study Sites (2)

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