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AnxietyGame ConnectNCT06464627

Physical Activity Reduces Anxiety and Depression in Youth Affected by Displacement: a Randomized Controlled Trial of the Game Connect Program in Uganda

A study testing Physical activity in people with Anxiety and Depression, run by KU Leuven at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial investigated 12 weeks of physical activity or to 12 weeks in a waiting control condition in youth aged 15 to 24 years old affected by displacement. Read more about this study

Who is it for?
Ages 15 to 24 years
Conditions the study is for
Anxiety, Depression
What is being tested?
Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
866 participants
Where
1 siteUganda
Study dates
1 Sep 2022to 31 Aug 2023
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 15 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • young displaced or host-community adolescents and young adults aged 15 to 24 years, and (b) at least mild symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score of 5 or higher

Who cannot join

  • young displaced or host-community adolescents and young adults younger than 15 and older than 24 years, and (b) no symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score lower than 5

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Makerere University

    Kampala

Other trials in Uganda

About this study

This randomized controlled trial investigated 12 weeks of physical activity or to 12 weeks in a waiting control condition in youth aged 15 to 24 years old affected by displacement.

Read the detailed description

In 2020, the Olympic Refuge Foundation (ORF) initiated Game Connect, a sport-for-protection project in Uganda. The current study lasted from September 2022 to August 2023. The project was executed by a consortium led by non-governmental organizations including AVSI Foundation, Right to Play, Youth Sport Uganda, the Uganda Olympic Committee, and the United Nations High Commissioner for Refugees. Included districts were Kampala, Rwamwanja, Palabek, Adjumani, and Kyangwali as they host the largest refugee settlements. Also the surrounding host communities were included. A total of 1,912 potential villages that could be targeted were identified, some of which were grouped in clusters. The decision to cluster villages was influenced by factors such as the limited number of young people in some villages and proximity of households to each other despite living in different villages. In total, 869 villages out of the 1,912 were at random selected for inclusion in the program. Block randomization was applied to ensure equal representation across the targeted districts. Following selection of the villages, all youth in selected villages were identified. Eligible participants in the selected 869 villages of the five catchment areas were: (a) young displaced or host-community adolescents and young adults aged 15 to 24 years, and (b) at least mild symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score of 5 or higher. Those with severe depression (PHQ-9-A≥20) and / or anxiety (GAD-7≥15) were eligible to participate, but additionally referred to local services for specialized support. Eligible young people were at random allocated to either 12 weeks of physical activity or to 12 weeks in a waiting control condition. All participants completed at baseline and immediately post-intervention the interviewer-administered PHQ-9-A (Spitzer et al., 1999) and GAD-7 (Spitzer et al., 2006). An independent team of well-trained research assistants performed the interviews to minimize potential bias. The research assistants were recruited locally from refugee settlements and surrounding host communities. Data collection tools were pretested to ensure coherence and understandability of questions before the actual data collection commenced. Ethical approval was obtained from the Makerere University School of Social Sciences Research Ethics Committee and the Uganda National Council for Science and Technology. Informed written assent was obtained from all participants. Consent was secured from the current caregivers of youths aged 15-17 years.

Conditions
Anxiety, Depression
Being tested
Physical activity
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06464627
Study groupRoleWhat they receive
Physical activityExperimentalThe project lasts 16 weeks and focuses on: improving skills and capacities of refugee and host community youth to support their psychosocial wellbeing and mental health through improved access to safe sport; developing a new/strengthened social and support network through safe sport, including those from diverse backgrounds among refugee and host community youth; working with and ensuring District Level officials appreciate and advocate for Sport for Protection activities.
Receives: Behavioral: Physical activity
Wait listNo interventionWait list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire-9

    Measured: 2 weeks

  2. Generalized Anxiety Disorder -7

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start1 Sep 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

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
RCT
Masking
Single blind
Who is masked
Participant
Enrolment
866 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464627
Sponsor's protocol ID
10.05.2024
Acronym
Game Connect
Status last verified
Jun 2024
First submitted
13 Jun 2024
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Anxiety and Depression, run by KU Leuven 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 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 18 Jun 2024. 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?

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 18 Jun 2024.

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