Clinical trial NCT05726669: Self-help Booklets for Depression in Adults With Pulmonary Hypertension.
Official title: Randomised Controlled Trial of Self-help Cognitive Behavioural Therapy for Depression in Adults With Pulmonary Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Depression
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: Nottingham Trent University
First posted: 2023-02-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised controlled trial (RCT) design will be used, with participants randomised on a 1:1 basis to either a CBT informed self-help intervention to help manage depression in pulmonary hypertension or a controlled wait list condition.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression
timeFrame: 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.
Secondary outcomes:
measure: Anxiety
timeFrame: 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.
measure: Health-related quality of life
timeFrame: 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.
measure: Fatigue
timeFrame: 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.
measure: Pain Self Efficacy
timeFrame: 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.
measure: Cognition and behaviours
timeFrame: 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.
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff University - however recruitment is done electronically
Study officials:
affiliation: Cardiff University
name: Abbie Stark, Psychology
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.
citation: Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
citation: Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
citation: Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.