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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
Physical activityBehavioural
16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | The 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 list | No intervention | Wait list |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Sep 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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.
- More trials run by KU LeuvenThe 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
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 866 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, The University of New South Wales, AVSI, Olympic Refuge Foundation
- Responsible party
- Principal investigator, Davy Vancampfort, KU Leuven
- Investigators
- Kathleen Latimer, Study director, Olympic Refuge Foundation
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Reduces Anxiety and Depression in Youth Affected by Displacement: a Randomized Controlled Trial of the Game Connect Program in Uganda
- ClinicalTrials.gov ID
- NCT06464627
- Acronym / sponsor ID
- Game Connect / 10.05.2024
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Makerere University, The University of New South Wales, AVSI, Olympic Refuge Foundation
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Jun 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityThe 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. |
| Wait list | No intervention | –Wait list |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Physical activity16 weeks | Behavioural | Physical activity |
Primary outcome
Patient Health Questionnaire-9
Time frame: 2 weeks
Generalized Anxiety Disorder -7
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 18 Jun 2024.
- 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.
Kathleen Latimer study director
Olympic Refuge Foundation
1 site in 1 country: see every site and its status.
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.