Condition category
Mental and Behavioural Disorders
Date applied
31/01/2020
Date assigned
06/02/2020
Last edited
05/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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?
Three groups of veterans with PTSD will each undertake a group outdoor activity (angling, equine care or archery and falconry). We will measure changes to their symptoms (PTSD, depression, anxiety) 2 weeks before the activity, 2 weeks after the activity, and at 4 month follow up.

What are the possible benefits and risks of participating?
Equine husbandry: There is some risk around horses. We will be working to the garrison stables health and safety guidelines and all participants are covered by the stables’ indemnity insurance, in case of an injury occurring. There will be a first aid trained member of staff in attendance at all times.

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?
June 2014 to June 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_1

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 pilot study

Acronym

Study hypothesis

It is hypothesized that participants will experience a reduction in PTSD-related symptomology and an increase in subjective well-being as a consequence of a short, outdoor, recreational activity.

Ethics approval

Approved 01/03/2015, 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: MW1502, MW1503

Study design

Single-centre interventional design study

Primary study design

Interventional

Secondary study design

Participants will be allocated to one of the three levels of the between groups factor

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

Participants will be recruited and randomly allocated to one of the three levels of the between-groups factor. They will be sequentially numbered and allocated to condition by means of an online blocked randomization tool.

The three intervention groups are angling, equine husbandry, and falconry and archery. The three different activity interventions will run sequentially and employ the same eligibility criteria, recruitment process, and evaluation. Each activity intervention lasts 1 to 2 days and are designed to deliver professional coaching in an outdoor recreational activity in a peer group context and to facilitate opportunities to socialize and to discuss military experience or PTSD experience if the participant so wishes.

Each participant will complete questionnaires to assess their PTSD, depression, anxiety, and stress. These will be given at 2 weeks before they receive the intervention, at 2 weeks following the intervention and at 4 months follow up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. PTSD symptoms assessed by the PTSD Checklist Military (PCL-M) 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

Perceived stress assessed by the 10-item Perceived Stress Scale (PSS) at baseline, 2 weeks and 4 months

Overall trial start date

16/06/2014

Overall trial end date

08/06/2015

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

50

Participant exclusion criteria

Currently receiving psychological therapy for PTSD

Recruitment start date

28/08/2014

Recruitment end date

08/03/2015

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

http://www.essex.ac.uk/

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

Publication citations

Additional files

Editorial Notes

05/02/2020: Trial’s existence confirmed by the University of Essex Ethics Committee.