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

ISRCTN ISRCTN12601214
DOI https://doi.org/10.1186/ISRCTN12601214
Secondary identifying numbers N/A
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

Study designSingle-centre pilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format
Scientific titleImproving psychological outcomes after venous thromboembolism (VTE): a pilot randomised control trial (RCT) of a brief intervention
Study objectivesThe 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) studiedVenous thromboembolism (VTE) and its impact on patients emotional and psychological well-being.
InterventionA 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 typeOther
Primary outcome measurePre 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 measuresQualitative and verbatim feedback from participants on the usefulness of the intervention, measured at one month post-intervention
Overall study start date01/10/2015
Completion date30/05/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants24
Key inclusion criteria1. 18-70 years
2. Either gender
3. Experienced a VTE in the previous 4 weeks
Key exclusion criteriaPatients diagnosed with serious comorbidities such as terminal cancer
Date of first enrolment01/10/2015
Date of final enrolment30/05/2016

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Nevill Hall Hospital
Brecon Road
Abergavenny
Monmouthshire, Wales
NP7 7EG
United Kingdom

Sponsor information

Swansea University
University/education

Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom

ROR logo "ROR" https://ror.org/053fq8t95

Funders

Funder type

Hospital/treatment centre

Nevill Hall Thrombosis Research Alliance

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planThis 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.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

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