Plain English Summary
Background and study aims
Venous thromboembolism (VTE) is a medical condition where a blood clot forms in a vein. It is a serious condition that is potentially fatal. VTE can refer to a deep vein thrombosis (DVT), which is a blood clot in one of the deep veins in the body (most commonly a leg) or pulmonary embolism, which is a blood clot in the blood vessel that transports blood from the heart to the lungs. Many patients who have suffered a VTE experience a significant amount of anxiety and post-trauma stress afterwards. This study investigates a brief intervention (or programme) that has been developed to reduce this distress and help patients cope better. The intervention is brief, easy for patients to use in their own home and consists of information and self-help tools known to be of benefit , including information about the illness and treatment as well as cognitive behavioural and mindfulness strategies for managing anxiety.
Who can participate?
Adults (aged 18-70) that have had a VTE within the last 4 weeks.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are provided with the brief intervention. Those in group 2 (control) are not. They are all asked to complete a series of questionnaires. After one month all participants are asked to complete the questionnaires again, measuring how anxious they feel and how they feel that their VTE has affected them. Participants in group 1 are also asked to give feedback on the intervention.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Nevill Hall Hospital, Abergavenny (Wales, UK)
When is the study starting and how long is it expected to run for?
October 2015 to May 2016
Who is funding the study?
Nevill Hall Thrombosis Research Alliance (Wales, UK)
Who is the main contact?
1. Dr Rachael Hunter (public)
2. Professor Paul Bennett (scientific)
Trial website
Contact information
Type
Public
Primary contact
Dr Rachael Hunter
ORCID ID
Contact details
Psychology Department
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
Type
Scientific
Additional contact
Prof Paul Bennett
ORCID ID
Contact details
Psychology Department
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving psychological outcomes after venous thromboembolism (VTE): a pilot randomised control trial (RCT) of a brief intervention
Acronym
Study hypothesis
The psychological outcomes for patients using the intervention after a venous thromboembolism (as assessed by measures of illness perceptions, health anxiety, post-trauma stress, anxiety and depression) will be improved compared to patients not receiving the intervention.
Ethics approval
Wales REC 6, 09/11/2015, ref: 15/WA/0382
Study design
Single-centre pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format
Condition
Venous thromboembolism (VTE) and it's impact on patients emotional and psychological well-being.
Intervention
A psycho-educational tool to reduce distress and improve psychological outcomes. It includes information about VTE and self-help tools for managing anxiety and low mood.
Participants are randomly allocated into one of two groups. Those in the intervention group are provided with the brief intervention. Those in the control group are not.
After one month patients we be asked to complete post-intervention outcome measures and provide feedback on the intervention if they received it. The results will be analysed to identify any effect or impact of the intervention.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Pre and post intervention questionnaires will be completed by patients. The questionnaire incorporates robust, standardised measures widely used in psychological research and include:
1. The Hospital Anxiety and Depression Scale (HADS)
2. Impact of Events Scale (IES) – Fear & dissociation Subscale
3. Brief illness perception questionnaire (IPQ)
4. Health Anxiety Inventory (HAI)
Measured at baseline and after one month.
Secondary outcome measures
Qualitative and verbatim feedback from participants on the usefulness of the intervention.
Measured at one month post-intervention.
Overall trial start date
01/10/2015
Overall trial end date
30/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. 18-70 years
2. Either gender
3. Experienced a VTE in the previous 4 weeks
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
Patients diagnosed with serious comorbidities such as terminal cancer
Recruitment start date
01/10/2015
Recruitment end date
30/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nevill Hall Hospital
Brecon Road
Abergavenny
Monmouthshire, Wales
NP7 7EG
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Nevill Hall Thrombosis Research Alliance
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This research will be submitted as part of a student PhD at Swansea University. It is hoped articles derived from the data will be published in peer reviewed journals and that this the results will also enable the development of a full RCT of the intervention.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary