Condition category
Circulatory System
Date applied
23/09/2015
Date assigned
29/09/2015
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Swansea University

Sponsor details

Singleton Park
Swansea
SA2 8PP
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.