Last reviewed · How we verify
NCT05061225
The Efficacy of a Physical Activity Counselling Intervention on Mental Health in Firefighters
NA trial testing Physical activity counselling in PTSD in 60 participants. Status unknown.
23 August 2022
Quick facts
| Lead sponsor | KU Leuven |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 11 October 2021 |
| Primary completion | 23 August 2022 |
| Estimated completion | 23 August 2022 |
Drugs / interventions tested
- Physical activity counselling
Conditions studied
- PTSD — all drugs for PTSD →
- Stress, Psychological — all drugs for Stress, Psychological →
- Depressive Symptoms — all drugs for Depressive Symptoms →
- Anxiety Disorders and Symptoms — all drugs for Anxiety Disorders and Symptoms →
Sponsor
KU Leuven — full company profile →
Who can join
Adults 18 to 65, any sex, with PTSD or Stress, Psychological. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objectives: The aim of this project will be to evaluate the efficacy of a lifestyle PA counselling program for physically inactive first responders with at least mild symptoms of either anxiety, depression or stress and their chosen support partners compared to a waiting list, and to determine the mediating effect of autonomous motivation. Additionally, the randomised controlled trial will be complemented with qualitative interviews to provide a deeper context and understanding to the quantitative findings. To the best of our knowledge, no randomized controlled trial to date has examined the outcomes of an online physical activity counselling intervention using peer-support in firefighters. Methods: Within mixed methods randomized controlled trials, we will follow a sequential explanatory design. In this design, qualitative results complement and help interpret quantitative findings. In order to address the main aims, a randomized controlled trial will be executed. CONSORT statement will be followed for reporting findings. Protocol will be submitted to clinicaltrials.gov. For addressing the secondary aim of the study, the study will follow a qualitative design based on interpretative phenomenology. Phenomenology is a model used for describing, understanding, and interpreting the lived experiences of the participants by means of discourse analysis. For the quantitative component, two arms with 24 firefighters will be required. Additionally, chosen support partners will enter the intervention arm. Participants in the intervention arm will be invited to a private facebook page where the researcher will upload weekly educational posts regarding different aspects of physical activity. For the qualitative component, participants will be invited to 2-3 focus groups where the experiences of the participants on the program will be discussed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05061225
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05061225 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by KU Leuven
- Last refreshed: 29 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05061225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing