Plain English Summary
Background and study aims
Exposure to the natural environment is increasingly thought to benefit psychological health. Recent reports also suggest that outdoor activities that include recreational pursuits (such as surfing or fishing) coupled with the opportunity to socialize with others in similar circumstances may be helpful to military veterans experiencing Post-Traumatic Stress Disorder (PTSD). This study will evaluate this possibility.
Who can participate?
Military veterans with a diagnosis of post-traumatic stress disorder
What does the study involve?
Veterans with PTSD will be allocated to either an active outdoor recreational pursuit (angling) or a waitlist control group (this group will receive the intervention at a later date). We will measure changes to their symptoms (PTSD, depression, anxiety and other aspects of well-being) 2 weeks before the intervention, 2 weeks after the intervention for both groups; The waitlist participants will be also be reassessed two weeks after they subsequently completed the intervention and both groups will be followed up 4 months post-intervention.
What are the possible benefits and risks of participating?
The participants for this study are military veterans with PTSD and other anxiety-related issues. They, therefore, have mental health problems but this is a defining aspect of the study and cannot be undertaken with participants without these issues. It is not thought there are any risks in this study above and beyond those normally encountered in everyday life.
It is thought that exposure to an outdoor recreational experience will be beneficial in terms of decreased anxiety, depression and PTSD-symptoms and increased well-being.
Where is the study run from?
Department of Psychology, University of Essex (UK)
When is the study starting and how long is it expected to run for?
May 2015 to December 2015
Who is funding the study?
This study did not receive any funding
Who is the main contact?
Dr. Nicholas Cooper
ncooper@essex.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nicholas Cooper
ORCID ID
http://orcid.org/0000-0002-4315-3299
Contact details
Department of Psychology
University of Essex
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
+44 (0)1206 873781
ncooper@essex.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Essex_NC1408_2
Study information
Scientific title
Examining the effects of outdoor recreational experiences on the mental health and well-being of military veterans with post-traumatic stress disorder (PTSD): a randomized controlled trial
Acronym
Study hypothesis
It is hypothesized that participants in the intervention group will experience a reduction in PTSD-related symptomology and an increase in subjective well-being relative to participants in a wait list control group, as a consequence of a short, outdoor, recreational activity.
Ethics approval
Approved 28/08/2014, the University of Essex Ethics Committee (Science & Health Ethics Sub-Committee, University of Essex, Wivenhoe Park, CO4 3SQ; reo-governance@essex.ac.uk; +44 (0)1206 87356), ref: NC1408
Study design
Randomized waitlist-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Post-traumatic stress disorder (PTSD)
Intervention
The intervention is designed to deliver an outdoor recreational activity (fishing) in a peer group context and to facilitate opportunities to socialize and to discuss military experience or PTSD experience if the participant so wishes. The intervention lasts 2 days (1 night) and will take place at a rural, lakeside location.
Participants will be randomly allocated to one of the two levels of the between-groups factor (to either active intervention or waitlist control). They will be sequentially numbered and allocated to condition by means of an online blocked randomization tool.
Each participant will complete questionnaires to assess their PTSD, depression, anxiety, and stress. The intervention group participants will be given these at 2 weeks before they receive the intervention, at 2 weeks following the intervention. The waitlist participants will be also be assessed at baseline and four weeks later. The waitlist group will also be reassessed two weeks after they subsequently completed the intervention. Both groups will be followed up 4 months post-intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. PTSD symptoms assessed by the PCL-5 at baseline, 2 weeks and 4 months
2. Depression assessed by the Patient Health Questionnaire (PHQ-9) at baseline, 2 weeks and 4 months
3. Anxiety assessed by the General Anxiety Disorder (GAD-7) at baseline, 2 weeks and 4 months
Secondary outcome measures
1. Perceived stress assessed by the 10-item Perceived Stress Scale (PSS) at baseline, 2 weeks and 4 months
2. General social functioning assessed by the Work and Social Adjustment scale (WSAS) at baseline, 2 weeks and 4 months
3. Positive change in psychological growth assessed by the Psychological Wellbeing Post-Traumatic Changes Questionnaire (PWB-PTCQ) at baseline, 2 weeks and 4 months
Overall trial start date
14/05/2015
Overall trial end date
18/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Military veteran
2. Diagnosis of post-traumatic stress disorder (PTSD)
Participant type
Other
Age group
All
Gender
Both
Target number of participants
25
Participant exclusion criteria
Currently receiving psychological therapy for PTSD
Recruitment start date
13/07/2015
Recruitment end date
27/07/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychology, University of Essex
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
Sponsor information
Organisation
University of Essex
Sponsor details
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
+44 (0) 1206 873591
lglover@essex.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the intervention will be published in a peer-reviewed international journal. They will also be presented at relevant national and international conferences and will be disseminated widely through social and conventional media platforms.
IPD sharing statement:
The datasets generated during and/or analyzed during the current study will be stored in a publically available repository. Our data are stored in an online repository OSF Home.
https://osf.io/63hrb/?view_only=2c8ffabdc8a64e77ba649c47f6df6c75 .
Data are de-identified participant data (IPD) and age and gender removed from the data sets because the small sample size risks identification. The data can be downloaded by anyone with the link. The link will also be provided in the published paper.
Intention to publish date
01/03/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list