The Efficacy of a Physical Activity Counselling Intervention on Mental Health in Firefighters

NCT05061225 | Unknown

• 1 other identifier: 3M200373
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PTSD; Stress, Psychological; Depressive Symptoms; Anxiety Disorders and Symptoms

Keywords

Exercise; PTSD; Firefighter; Physical Activity; Stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Simple Physical Activity Questionnaire. Changes in Physical Activity levels

  5-item clinical tool to assess physical activity levels among populations at high risk for physical inactivity.

  Baseline, immediately after intervention, at 3 months follow-up

• PTSD checklist for the DSM-5. Changes in PTSD symptoms.

  A self-report assessment tool that measures symptoms of post-traumatic stress according to the DSM-5 during the past month with the aim of monitoring symptom change, screening individuals for PTSD, or making a provisional PTSD diagnosis. Higher scores imply more severity, ranging from 0 to 80.

  Baseline, immediately after intervention, at 3 months follow-up

Secondary Outcomes (7)

• Behavioural Regulation for Exercise, Third Edition. Changes in quality of motivation

  Baseline, immediately after intervention, at 3 months follow-up

• Alcohol Use Disorders Identification Test. Changes in Alcohol use.

  Baseline, immediately after intervention, at 3 months follow-up

• Social Support for Exercise Behaviours Scale. Changes in Social Support.

  Baseline, immediately after intervention, at 3 months follow-up

• Pittsburgh Sleep Quality Index. Changes in Sleep Quality.

  Baseline, immediately after intervention, at 3 months follow-up

• The Depression and Anxiety Stress Scale - 21. Changes in symptoms of depression, anxiety, and stress.

  Baseline, immediately after intervention, at 3 months follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Participants invited to the private Facebook group

Behavioral: Physical activity counselling

Waiting list

NO INTERVENTION

Waiting list. Will be invited to Facebook group after finalising the study and will receive same intervention.

Interventions

Physical activity counselling BEHAVIORAL

Educational content on several topics regarding physical activity and its implementation in daily living

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Physically inactive (less than 150 minutes of moderate to vigorous physical activity per week)
• Active as a firefighter
• At least mild symptoms of depression, anxiety or stress according to the DASS-21

You may not qualify if:

• Acute suicide ideation
• Unfit to engage in physical activity

Sponsors & Collaborators

• KU Leuven: lead
• Fire Stress Team: collaborator

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress, Psychological; Depression; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Davy Vancampfort, dr

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos P Ramos Sánchez

CONTACT

485431234; carlos.ramossanchez@kuleuven.be

Davy Vancampfort, dr

CONTACT

davy.vancampfort@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 29, 2021
• Study Start: October 11, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09