A trial of a brief intervention to improve emotional distress after thrombosis

ISRCTN	ISRCTN12601214
DOI	https://doi.org/10.1186/ISRCTN12601214
Protocol serial number	N/A
Sponsor	Swansea University
Funder	Nevill Hall Thrombosis Research Alliance

Submission date: 23/09/2015
Registration date: 29/09/2015
Last edited: 06/06/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Rachael Hunter
Public

Psychology Department
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom

Prof Paul Bennett
Scientific

Psychology Department
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre pilot randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Improving psychological outcomes after venous thromboembolism (VTE): a pilot randomised control trial (RCT) of a brief intervention
Study objectives	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(s)	Wales REC 6, 09/11/2015, ref: 15/WA/0382
Health condition(s) or problem(s) studied	Venous thromboembolism (VTE) and its 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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Qualitative and verbatim feedback from participants on the usefulness of the intervention, measured at one month post-intervention
Completion date	30/05/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	24
Key inclusion criteria	1. 18-70 years 2. Either gender 3. Experienced a VTE in the previous 4 weeks
Key exclusion criteria	Patients diagnosed with serious comorbidities such as terminal cancer
Date of first enrolment	01/10/2015
Date of final enrolment	30/05/2016

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Nevill Hall Hospital

Brecon Road
Abergavenny
Monmouthshire, Wales
NP7 7EG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/06/2018: No publications found, verifying study status with principal investigator.
24/03/2016: Ethics approval information added.