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

NCT05726669 | Completed

• 1 other identifier: PHDEP2023
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Depression

Outcome Measures

Primary Outcomes (1)

• Depression

  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.

  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 (5)

• Anxiety

  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.

• Health-related quality of life

  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.

• Fatigue

  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.

• Pain Self Efficacy

  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.

• Cognition and behaviours

  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.

Study Arms (2)

Intervention group

EXPERIMENTAL

Self-help intervention based on cognitive behavioural therapy for depression in pulmonary hypertension. There will be four booklets which will take four weeks for participants to work through in their own time at home.

Other: Self-help materials for depression

Wait list control group

NO INTERVENTION

The wait list control group will not receive the self-help intervention, and will be compared to the intervention group on the outcome measures. The wait-list control group will receive the intervention after study completion if it is found to be helpful (June 2024).

Interventions

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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current thoughts of self-harm or suicide.

Sponsors & Collaborators

• Cardiff University: lead
• Nottingham Trent University: collaborator

Study Sites (1)

Cardiff University - however recruitment is done electronically

Cardiff, CF10 3AT, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 18752852 RESULT

• 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.

  PMID: 16717171 RESULT

• 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.

  PMID: 24232702 RESULT

• 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.

  PMID: 34593508 RESULT

• 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.

  PMID: 16446108 RESULT

• 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.

  PMID: 23791482 RESULT

• 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.

  PMID: 18824488 RESULT

MeSH Terms

Conditions

Hypertension, Pulmonary; Depression

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Abbie Stark, Psychology

  Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both participants and researchers will not be blinded to condition. This is necessary as participants will know before they consent to the study that they may be randomised to a wait list condition or the intervention, and the lead researcher will contact participants during the intervention (at two weeks) to gather acceptability and adherence feedback. Therefore the researcher needs to know who is in the intervention group to contact them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: June 8, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the study is complete, electronic files will be stored for a minimum of 15 years by Cardiff University after the end of the project or after publication of any findings based upon the data (whichever is later). The end of project is defined as completion of project closure report or publishing of final articles. This follows Cardiff University's research records retention policy. Data can be made available following study completion, up until the point of disposal of data after 15 years.
• Access Criteria: Data will be made available to researchers upon reasonable request.

Locations

GB (1)