Project Objectives The primary aim of this study is to develop a self-management intervention
in collaboration with patient, public involvement, which will consist of experts by
experience and experts by education. The intervention is aimed at helping individuals with PH
to manage symptoms of anxiety.
A secondary aim of the project is to conduct a pilot randomised controlled trial
investigating the aforementioned self-management intervention. More specifically, the project
will explore acceptability and feasibility of the intervention itself and research
methodology proposed to test its effectiveness. Qualitative and quantitative data will be
collected for this purpose which will focus on: attrition rates; adherence to the
intervention; participant's acceptability of the intervention and research methodology (i.e.
eligibility, randomisation, emotional response, perceptions); outcome measures; recruitment
and data collection procedures; and any adverse effects. Moreover, this project will
investigate the preliminary efficacy of the intervention on a series of primary (anxiety
symptoms
- - Generalised Anxiety Disorder -7) and secondary measures (depression - PHQ9);
HRQoL- emphasis10); dyspnoea - dyspnoea12; perception of coping - self-mastery questionnaire;
and cognitive and behavioural processes (Cognitive Behavioural Processes Questionnaire
(CBPQ), so that effect sizes can be calculated and used to inform sample sizes of any future
definitive trials.
Design The study will be a pilot randomised superiority trial. Participants will be
randomised on a 1:1 basis to either one of two groups,
- (1) CBT informed self-management
intervention to help manage anxiety in PH or a (2) controlled waiting-list condition.
A
control condition is required to control for any therapeutic gains associated with being
involved in a trial. Participants will be asked to complete a series of measures pre-, post-
and one month following completion of the intervention. As such, a 2 (cognitive-behavioural
informed intervention or control waiting list) x 3 (pre-, post- and intervention) research
design will be used. Participants or researchers will not be blinded to condition allocation
(i.e. participants will be aware they may be randomised to a waiting list condition, and
researchers may be contacting participants during the intervention for feedback on adherence
and acceptability).
Procedure From the study advert promoted by the Pulmonary Hypertension Association,
participants will be directed to a dedicated webpage for the proposed project.
From there, participants will be able to read the participant information sheet. Participants
interested in talking part will be asked to click on a link that will take them to a series
of questionnaire hosted by Qualtrics. Participants will first be asked to complete an
eligibility form. Based on their responses, if participants are not eligible they will be
informed immediately that they are unable to participate in the study. If participants are
eligible, they will be asked to complete a consent form and a series of questionnaires (see
below). All data entered on this page will be recorded, as it will help to inform feasibility
of the inclusion/exclusion criteria (i.e. is the study excluding a large percentage of people
based on a certain factor).
Participants will also be informed on the advert promoted by the Pulmonary Hypertension
Association, that they can contact the lead researcher (Gregg Rawlings) to ask any additional
questions about the project prior to completing the eligibility form, consent form and/or
questionnaires.
Eligible participants will be randomised, using an online randomiser, to either of the two
arms. The programme used to randomise will be Random.org. Those randomised to the wait-list
condition will be informed that they will be contacted again in four weeks asking them to
complete a series of questionnaires and again in an additional month (see below). Those in
the intervention condition will be sent the CBT intervention.
Participants in the intervention condition will be instructed to work systematically through
the intervention. Two weeks after the intervention is sent to participants, participants will
be contacted by the lead researcher (Gregg Rawlings) to check on adherence and acceptability
of the intervention using a mixed-methods structured questionnaire. Participants will be
attempted to be contacted a maximum of three times. Participants will have provided prior
consent to be contacted.
Four weeks following the intervention being received and one month thereafter participants
will be contacted asking them to complete the outcome measures (see below). During this time,
participants will be contacted asking them to complete a quantitative and qualitative
questionnaire on their views of participating in the intervention. This will be hosted by
Qualitrics. Participants will have provided consent to be contacted for this purpose.
Data analysis. Quantitative data:
- - Descriptive statistics, and a series of independent T-tests for continuous data and chi
square tests for categorical data will be used to compare participants in the two
intervention arms at baseline.
This will help to indicate whether randomisation was
effective and inform additional analyses i.e. certain variables may need to be
controlled for using ANCOVAs or ANCOVA.
- - A series of independent T-tests for continuous data and chi square tests for categorical
data will be used to compare participants who have dropped out versus those who
completed the study.
This will help to further understand acceptability and reasons for
attrition.
- - Descriptive statistics will be reported for rates of attrition and data collected from
the feedback questionnaires.
- - To explore the potential effectiveness of the intervention, a mixed ANOVA or ANCOVA
analysis will be conducted with assessment (pre-, post-intervention and one-month
follow) being the within subjects factors and intervention arm (self-help intervention
or waitlist) being the between subject factor.
This will be conducted for the primary
measure and each of the secondary measures. As this is a pilot study and not testing
effectiveness specifically, intent to treat analysis and Bonferroni corrections will not
be performed. Cohen's d will be used to interpret observed effect sizes using the
parameters discussed above. A significance level of alpha (0.05) will be adopted for all
statistical analysis reported. SPSS25 will be used for all statistical analysis.
- - To calculate the post-hoc power analysis to inform sample sizes of future definitive
randomised controlled trials, G*Power software will be used utilising the same
parameters as above (i.e. two-tailed, alpha level and 80% power) - given the assumptions
of the ANOVA or ANCOVA were met and therefore the effect size is valid.
This will be
conducted using the results from the primary outcome measure (GAD-7) and an average size
of secondary measures.
Qualitative data: Qualitative data gathered from the feedback questionnaires will be analysed
using a descriptive version of thematic analysis. This will adhere to the stages outline by
Braun and Clarke:
1. Become familiar with the transcripts through repeated readings
- - participant's responses
will already be in electronic format as it is collected via Qualtrics and so
transcriptions will not be needed.
2. Undertake iterative coding of each transcript re-coding each narrative as new codes
emerge.
3. Collate and contrast codes to create main- and sub-themes.
4. Review the themes and discuss the findings with members of the research team.
5. Final refinement of themes identifying clear titles and selecting appropriate quotations
in support of each theme.
6. Write up the report making the outcome of the analysis coherent.
