Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726669
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2023-02-03
Brief Title:
Self-help Booklets for Depression in Adults With Pulmonary Hypertension
Sponsor:
Cardiff University
Organization:
Cardiff University
Study Overview
Official Title:
Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short
CBT looks at the way people think and what they do and how this affects their mood
It involves making changes to thoughts and behaviours
CBT can help people develop more helpful ways of coping with depression
CBT is one of the most effective therapies for depression this means it works well
There are four booklets that participants will work though weekly in their own time and at home The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension
Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety
They will then be allocated at random to one of two groups Group one will receive the self-help booklets called the intervention group Group two or the wait list group will receive the intervention at a later date if it is found to be helpful Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else
Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part
Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month Participants in group one will be contacted again to find out more about their experiences of the project
CBT looks at the way people think and what they do and how this affects their mood
It involves making changes to thoughts and behaviours
CBT can help people develop more helpful ways of coping with depression
CBT is one of the most effective therapies for depression this means it works well
There are four booklets that participants will work though weekly in their own time and at home The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension
Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety
They will then be allocated at random to one of two groups Group one will receive the self-help booklets called the intervention group Group two or the wait list group will receive the intervention at a later date if it is found to be helpful Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else
Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part
Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month Participants in group one will be contacted again to find out more about their experiences of the project
Detailed Description:
Previous research has demonstrated high rates of depression in people with pulmonary hypertension PH The psychological interventions that support people with depression are not made specific to people with PH and may not be relevant for them and there is limited evidence examining psychological treatments for depression in people with PH The aim of this study is to develop and test a self-help psychological intervention for depression based on cognitive behavioural therapy CBT which has been developed specifically for individuals with PH When participants have agreed to take part they will be allocated at random into an intervention or wait-list group The self-help materials will be provided online for people outside of the UK or posted in paper form for those living in the UK and will take four weeks to complete at home Both groups will complete questionnaires at the same time points before starting the study after four weeks and after eight weeks pre- post-intervention and one-month follow up In addition the intervention group will be contacted after two weeks of their participation and asked about their experiences of the intervention and participation in the study - measuring acceptability of the intervention The intervention group will also be asked to complete a feedback questionnaire after completing the intervention to further examine acceptability Analysis will be conducted by the researcher to examine whether the self-help intervention reduced depression in individuals with PH compared to those with PH who did not receive the intervention The potential benefit of the study includes a new intervention for depression in people with PH When the study is completed if the intervention is found to be helpful and safe then the people who took part in the study and did not receive the intervention will be offered the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None