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Completed

NCT Number: NCT05726669

Self-help Booklets for Depression in Adults With Pulmonary Hypertension.

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.

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Key information

Conditions

Pulmonary Hypertension Behavior Behavioral Symptoms Cardiovascular Diseases Depression Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff University - however recruitment is done electronically

Cardiff, CF10 3AT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Current thoughts of self-harm or suicide.

Treatment and study plan

Self-help materials for depression

Other

Self-help materials for depression based on cognitive behavioural therapy have been created and tailored to those with PH by researchers involved in this project, using the evidence base and theory plus clinical experience. The Medical Research Council Frameworks for complex interventions (Craig et al., 2008; Skivington et al., 2021) have been followed as well as the quality appraisal tool for self-help interventions in depression (Cape, 2015). The self-help materials will be shared for feedback with a readership panel of people with PH and caregivers who are members of Pulmonary Hypertension Association UK (a charity for people with PH) prior to being given to participants. The self-help materials will be provided online or posted in paper form to the intervention group and will take four weeks for the person to complete at home (one booklet per week).

Primary outcomes

  1. Depression

    Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.

    The Patient Health Questionnaire (PHQ-8) (Kroenke et al., 2009) will be used to measure depression as the primary outcome. The minimum score is 0 and the maximum score is 24. A higher score indicates a worse outcome.

Secondary outcomes

  1. Anxiety

    Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.

    The Generalised Anxiety Disorder (GAD-7) (Spitzer et al., 2006) will be used to measure anxiety. The minimum score is 0 and the maximum score is 21. A higher score indicates a worse outcome.

  2. Health-related quality of life

    Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.

    The emPHasis-10 (Yorke et al., 2014) will be used to measure health-related quality of life. The minimum score is 0 and maximum score is 50. A higher score indicates a worse outcome.

  3. Fatigue

    Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.

    The Fatigue Severity Scale (FSS) (Learmouth et al., 2013) will be used to measure fatigue. The minimum score is 9 and the maximum score is 63. A higher score indicates a worse outcome.

  4. Pain Self Efficacy

    Time frame: Pre-, post intervention and one month follow up. This means before starting the study, after four weeks and after eight weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.

    The Pain Self-Efficacy Questionnaire (Nicholas, 2007) will measure pain. The minimum score is 0 and the maximum score is 60. A higher score indicates a better outcome.

  5. Cognition and behaviours

    Time frame: Pre-, post intervention and one month follow up.This means before starting the study, after 4 weeks and after 8 weeks. Analysis will test if there is a change at baseline, post intervention and follow up between groups.

    To examine whether cognitions and behaviours have an impact on change in depression, the Cognitive Behavioural Processes Questionnaire (CBP-Q) will be used. The minimum score is 0 and the maximum score is 120. A higher score indicates a worse outcome.

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Collaborators

  • Nottingham Trent University

Registry information

Official study title

Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2023
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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