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?
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

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.