NCT05726669Completed
Self-help Booklets for Depression in Adults With Pulmonary Hypertension.
Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.
Source: ClinicalTrials.gov · Last updated 20 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 3 Feb 2023
- Start date
- 8 Jun 2023
- Primary completion date
- 12 Mar 2024
- Lead sponsor
- Cardiff University
- NCT number
- NCT05726669
What you commit to
- Study type: Interventional
- Participants enrolled: 68
- From 8 Jun 2023 to the primary completion date, 12 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Current thoughts of self-harm or suicide.
Who the study is looking for
- Diagnosis of pulmonary hypertension
- Over the age of 18 years
- Able to complete questionnaires without help from others
- Can understand English
- They will read all study documents in detail and ask the researcher any questions they have. Based on this, they could provide informed consent to take part if they are eligible.
- Feels like they have difficulties with depression, low mood or negative thoughts.
- Not currently experiencing thoughts of self-harm or suicide. This means that they have not had thoughts of self-harm or suicide within the last month.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiff University - however recruitment is done electronically Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.