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

Primary Purpose

Pulmonary Hypertension, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-help materials for depression
Sponsored by
Cardiff University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiff University - however recruitment is done electronicallyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Wait list control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anxiety
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.
Health-related quality of life
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.
Fatigue
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.
Pain Self Efficacy
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.
Cognition and behaviours
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.

Full Information

First Posted
February 3, 2023
Last Updated
August 29, 2023
Sponsor
Cardiff University
Collaborators
Nottingham Trent University
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1. Study Identification

Unique Protocol Identification Number
NCT05726669
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiff University
Collaborators
Nottingham Trent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Self-help materials for depression
Intervention Description
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 Outcome Measure Information:
Title
Depression
Description
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.
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.
Secondary Outcome Measure Information:
Title
Anxiety
Description
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.
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.
Title
Health-related quality of life
Description
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.
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.
Title
Fatigue
Description
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.
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.
Title
Pain Self Efficacy
Description
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.
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.
Title
Cognition and behaviours
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abbie Stark, Psychology
Phone
02920 870582
Email
starkas1@cardiff.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Andrew Thompson
Phone
02920 870582
Email
thompsona18@cardiff.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbie Stark, Psychology
Organizational Affiliation
Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiff University - however recruitment is done electronically
City
Cardiff
ZIP/Postal Code
CF10 3AT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abbie Stark, Psychology
Email
starkas1@cardiff.ac.uk
First Name & Middle Initial & Last Name & Degree
Abbie Stark, Psychology

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study investigators aim to publish the final report in a peer reviewed international journal and also make the anonymised data available in Cardiff University's data repository. The investigators would also like to share the findings in conferences. The data in anonymised format would be available to other researchers upon reasonable request. 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.
IPD Sharing 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.
IPD Sharing Access Criteria
Data will be made available to researchers upon reasonable request.
Citations:
PubMed Identifier
18752852
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.
Results Reference
result
PubMed Identifier
16717171
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.
Results Reference
result
PubMed Identifier
24232702
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.
Results Reference
result
PubMed Identifier
34593508
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.
Results Reference
result
PubMed Identifier
16446108
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.
Results Reference
result
PubMed Identifier
23791482
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.
Results Reference
result
PubMed Identifier
18824488
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.
Results Reference
result

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

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