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The impact of an exercise training intervention on cortisol levels and Post-Traumatic Stress Disorder in Congolese refugees: Study protocol for a randomized control trial

The impact of an exercise training intervention on cortisol levels and Post-Traumatic Stress Disorder in Congolese refugees: Study protocol for a randomized control trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014280
Enrollment
198
Registered
2018-03-15
Start date
2019-01-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F43.1

Interventions

Group 1: Exercise Training Group (ETG) The participants in the Exercise Training Group will attend three exercise sessions every week for a total number of eight weeks. That makes this training a chro
Polar, Kempele, Finland) [46]. Group 2: Alternative Intervention Group (AIG) The participants will attend three 45-minute sessions a week for a total number of eight weeks. The training of the AIG wi

Sponsors

MSH Medical School Hamburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 16 Years

Inclusion criteria

Inclusion criteria: Participants eligible for inclusion in the intervention only involve individuals with a diagnosis of PTSD according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V).

Exclusion criteria

Exclusion criteria: Exclusion criteria covers 1) acute suicidality, acute intoxication, or psychotic symptoms, 2) inability of the parent or legal guardian to provide consent, or 3) child protection issues (e.g., acute maltreatment) that are identified during the initial cross- sectional assessment and judged by a clinician to make trial inclusion inappropriate. Additionally, the participants may not be part of any other psychological therapy or take any medication with psychoactive drugs until the study is completed. We further control for an unchanged physical activity level during the intervention.

Design outcomes

Primary

MeasureTime frame
Psychological disorders The Mini International Neuropsychiatric Interview - Kid 7.0.2 (M.I.N.I.; [50]) represents a shortened psychiatric interview on the basis of DSM-V in order to help clinicians diagnose and evaluate the major psychiatric disorders. The test takes about 15-20 minutes and is performed in form of a standardized interview. The M.I.N.I. will help to identify acute co-morbid diseases relevant for eligibility of the participants. It will be used at t0 "Eligibility". Trauma The UCLA Child/Adolescent PTSD Reaction Index for DSM-5 (UCLA; [49]) is a screening tool recommended by the National Center for PTSD to collect data about the kind of traumatic happening the participants experienced. It is a 24-item questionnaire assessed to DSM-V criteria for PTSD and will be used at t1 "Baseline" For the more in-depth baseline PTSD assessment, the Clinical Administered PTSD Scale for DSM-5 Child/Adolescent Version (CAPS-CA-5; [51]) will be applied. The CAPS-CA-5 is a 30-item structured interview for the assessment of PTSD based on DSM-5 criteria. The interview will take about 45-60 minutes and is considered the gold standard for assessing PTSD severity. The CAPS-CA-5 has excellent psychometric properties and has already been successfully administered in other East-African samples [52]. It will serve as the main psychological outcome variable and will be collected at t1 Baseline, t1b Interim-test, t2 Post-test, t3 3-month follow up, and t4 6-month follow up Physical performance In the Shuttle Run Test the participants have to run alternately between two lines that are 20 meters separated from each other. The running speed will be given by intervals between tone signals. The interval between those signals will be reduced at every level. At the beginning of the test, the running speed is 8 km/h. Every minute it will increase by 0.5km/h. One minute is roughly equivalent to one level of the shuttle run test. Every time the acoustic hint sounds, the participants hav

Secondary

MeasureTime frame
The adapted Version of the Patient Health Questionnaire (PHQ-A; [53]) for the use in adolescent samples will be used as a measure to assess the participants’ depressive symptomatology. It is a brief 9-item measure that assesses clinically significant symptoms of depressive disorders and episodes in children ages 11-17. The Strengths and Difficulties Questionnaire (SDQ; [54]) is a brief behavioral screening questionnaire that can serve to identify psychosocial, emotional, and behavioral problems. It is a widely used 25-item measure that has shown its usefulness in various studies and different populations with mental health problems. The Psychlops [55] is a client-generated outcome measure for the assessment of the main psychological problem from the patients’ perspective. It is designed to measure longitudinal changes over the course of an intervention and provides different questions for the baseline, the interim, and the follow-up assessments. In this study, it will also help to capture the most significant mental health problems beyond the diagnoses specific approach. The body mass index will also be calculated by taking the body weight in kilograms and dividing it by the height [59]. The total body fat will be determined by using a skinfold caliper.

Countries

Uganda

Contacts

Public ContactHenning Budde

MSH Medical School Hamburg

henning.budde@medicalschool-hamburg.de0049 4036122640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026