An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help Intervention for Depression in People With Skin Conditions.
Phase: NA
Conditions: Dermatologic Disease, Depression
Sponsor: University of Sheffield

Investigating Compassion-Based Guided Self-Help for Depression in People 
with Skin Conditions 
Elaine Clarke 
NCT04132973 
Study protocol and statistical analysis plan 
Document date: 9th Sept 2019 
Uploaded to PRS: 19th Aug 2021 
 

Running head: COMPASSION-BASED SELF-HELP FOR SKIN CONDITIONS
1
An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help
Intervention for Depression in People with Skin Conditions
Elaine Clarke, Andrew R Thompson and Paul Norman
University of Sheﬃeld
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An Acceptability and Feasibility Study of a Compassion-Based Guided Self-Help
Intervention for Depression in People with Skin Conditions
Skin conditions are among the most common health complaints in the world: skin
disease is the fourth leading cause of nonfatal disease burden (Hay et al., 2013). In the
UK, an estimated 54% of the population experience a skin condition each year. While
the majority (69%) of these people self-care, almost 13 million people in England and
Wales visit their GP each year for skin complaints, with 0.8 million people being referred
on for specialist care (All Party Paliamentary Group on Skin, 2013). While some skin
conditions are resolved relatively quickly, others are life-long conditions. The impact of
skin conditions can be considerable, for example, psoriasis has been found to have a
similar impact on health-related quality of life as diseases such as cancer, arthritis, and
heart disease (Rapp, Feldman, Exum, Fleischer, & Reboussin, 1999). As well as causing
symptoms that are diﬃcult to live with, skin conditions can impact other areas of
individuals’ lives, including work/school, daily activities, leisure, personal relationships
and socialising (de Aruda & de Moraes, 2001; Dures, Morris, Gleeson, & Rumsey, 2011;
Sampogna, Tabolli, & Abeni, 2012). A further, related, impact of skin conditions is on
mental health. Living with a chronic skin condition can involve ongoing diﬃculties in
the aforementioned areas, which can be sources of stress. In addition, people with skin
conditions may experience appearance concerns and self-criticism if they perceive
themselves to be falling short of their ideal standards due to their skin condition. This
may lead to feelings of shame and anxiety. Indeed, skin conditions have been found to
be associated with higher than average levels of psychological distress. Studies have
found overall psychiatric morbidity among dermatology patients of 25.2% (Picardi,
Abeni, Melchi, Puddu, & Pasquini, 2000), and signiﬁcantly higher rates of depression,
anxiety and suicidal ideation than people without skin conditions (Dalgard et al., 2015).
Psychological treatments for people with skin conditions
There are few psychological treatments available speciﬁcally for people with skin
conditions: the ones most used are habit reversal, cognitive behavioural therapy (CBT),
arousal reduction and combined techniques (Lavda, Webb, & Thompson, 2012). Habit
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reversal focuses on reducing itch/scratch cycles, to improve the condition of the skin in
pruritic conditions. CBT focuses on changing unhelpful thoughts and behaviours
associated with the skin condition while arousal reduction focuses on reducing
physiological arousal through techniques such as relaxation or meditation.
Psychological treatments for people with skin conditions often focus on anxiety
rather than depression (for example, A. Clarke, Thompson, Jenkinson, Rumsey, &
Newell, 2014), as it has been noted that people with conditions that alter their
appearance can experience similar diﬃculties to people with social anxiety disorder,
such as fear/avoidance cycles about public scrutiny (Bessell & Moss, 2007). However,
not all people with skin conditions experiences diﬃculties with (social) anxiety as their
primary psychological problem. Clinical depression has been found to be present in
10.1% of dermatology patients (Dalgard et al., 2015). Although anxiety problems were
more common in this population (17.2%), the odds ratio for depression was higher
(Dalgard et al., 2015). Furthermore, depression is associated with a higher average level
of disability than anxiety disorders (World Health Organisation, 2017), and so there is a
need to develop psychological interventions for people with skin conditions that focus on
depression.
Guidelines for the treatment of depression recommend using a stepped care
approach (National Institute for Health and Clinical Excellence [NICE], 2009; NICE,
2010), in which the least restrictive treatment that is likely to improve health is ﬁrst
recommended, and then more intensive treatment is provided as necessary if the patient
fails to improve with the lower intensity treatment (Bower & Gilbody, 2005). Low
intensity interventions require the least resources and so can be provided to more
patients than the higher intensity interventions. One type of low intensity intervention
is ‘guided self-help’, in which patients receive self-help materials and limited support
from a trained practitioner. Research has shown that guided self-help is more eﬀective
for depressive symptoms than ‘pure’ self-help (without support), and that diﬀerent
modes of guidance (face-to-face support and other methods such as email) are equally
eﬀective (Gellatly et al., 2007). As well as being cost-eﬀective, guided self-help can
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enable patients to access an intervention despite geographic or time restrictions,
particularly if the guidance is provided remotely, for example, by telephone or email.
Although evidence-based interventions for depression already exist (NICE, 2009),
it is recognised that depression and chronic physical health problems can adversely
aﬀect each other: the impacts of chronic physical health problems increase the risk of
depression, while depression can exacerbate pain and distress in people with physical
illnesses (NICE, 2010). Given the relationship between depression and chronic physical
health problems, interventions for depression should acknowledge the presence and
impact of chronic physical health conditions. Previous qualitative research has noted
that generic computerised interventions for depression need to be adapted for people
with chronic physical conditions (Hind et al., 2010). Skin-speciﬁc self-help for
depression is likely to be a valuable resource as many people with skin conditions
manage alone or with the help of their GP only, and even for people who are referred to
dermatology services, access to psychological support is limited (All Party Paliamentary
Group on Skin, 2013).
In a review of self-help for people with visible diﬀerences, Muftin and Thompson
(2013) identiﬁed ﬁve studies with people with skin conditions. The only study that used
an intervention speciﬁcally developed for people with a skin condition (psoriasis) found
that it was not eﬀective for depression (Bundy et al., 2013). This intervention was a
computerised CBT programme designed for people with psoriasis. The authors
suggested that the relatively low level of depression in the sample could have
contributed to the lack of signiﬁcant eﬀect on depression. In addition, the study
suﬀered from a high attrition rate (43% in the intervention arm), which suggests a
problem with acceptability of the intervention. Two further studies investigated
interventions designed for people with visible diﬀerences, which could potentially be
used by people with skin conditions (Bessell et al., 2012; Newell & Clarke, 2000). Both
interventions focused on addressing social anxiety, and while some improvements in
depression were also found, most of the interventions’ content would not be relevant for
individuals with skin conditions for whom depression was the primary psychological
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problem. Two other studies in the review investigated the eﬀect of generic self-help
interventions for depression in samples of people with skin conditions. One of these
studies found that Mindfulness-Based Stress Reduction did not reduce depression
among people with psoriasis (Jackson, 2006). In the other study, two techniques based
on Compassionate Mind Training (Gilbert & Irons, 2005) were investigated with people
with acne (Kelly, Zuroﬀ, & Shapira, 2009). Both self-soothing and attack-resisting
self-help reduced shame at two weeks compared to the control, but only the
attack-resisting intervention reduced depression. The results of this review indicate that
there is a need to develop interventions for depression in people with skin conditions.
The development of compassion-based self-help
In recent years there has been increasing interest in the use of compassion as a
therapeutic tool, with several compassion-based interventions having been developed
(see Kirby, 2017, for a review). Being self-compassionate may be a particularly adaptive
strategy for people with skin conditions, as for some people, skin symptoms can trigger
negative self-evaluations (Thompson, Clarke, Newell, Gawkrodger, & the Appearance
Research Collaboration [ARC], 2010; Wahl, Gjengedal, & Hanestad, 2002). A
meta-analysis of compassion-based interventions (n = 470) reported that
compassion-based interventions are eﬀective for treating depression, with an average
eﬀect size of d = 0.64 (Kirby, Tellegen, & Steindl, 2017). Of the various interventions
that have been investigated, Compassion Focused Therapy (CFT; Gilbert, 2010) is the
only intervention that was speciﬁcally developed for use in clinical populations, and
therefore self-help based on this may be particularly beneﬁcial for people with
depression. In particular, CFT was developed for people with problems with shame and
self-criticism, which are known to contribute to depression (Gilbert & Irons, 2005). In
CFT, compassion is described as “a sensitivity to suﬀering in self and others, with a
commitment to try to alleviate and prevent it” (Gilbert, 2014, p. 19). CFT is an
adaptation of CBT that focuses on learning to be compassionate to oneself as a
therapeutic response to one’s suﬀering (Gilbert, 2010). Within CFT, ‘Compassionate
Mind Training’ (CMT) is used to refer to the exercises that patients practise to increase
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their abilities to be compassionate.
While there are many published studies on CFT (see Beaumont & Hollings
Martin, 2015; Leaviss & Uttley, 2015, for reviews), research on self-help based on CFT
is in its infancy. Despite this, CFT-based self-help has been shown to improve
depression in a variety of populations: students (McEwan & Gilbert, 2016), self-critical
people (Krieger, Martig, van der Brink, & Berger, 2016; Krieger et al., 2018)1, people
with low–moderate wellbeing (Sommers-Spijkerman, Trompetter, Schreurs, &
Bohlmeijer, 2018) and perinatal and intending-to-become-pregnant women (Kelman,
Evare, Barrera, Muñoz, & Gilbert, 2018). Furthermore, two of these studies found that
treatment gains were maintained at six-month follow-up (McEwan & Gilbert, 2016;
Krieger et al., 2018), and one found that online CMT was superior to online CBT for
depression (Kelman et al., 2018).
Although psychological interventions are intended to improve people’s lives,
negative emotions and distress are common side eﬀects, for example, aﬀecting around
27% of CBT patients (Schermuly-Haupt, Linden, & Rush, 2018). As well as
demonstrating beneﬁts from their self-help interventions, three of the above studies
investigated negative eﬀects. McEwan and Gilbert (2016) concluded that
compassion-focused imagery could safely be practised using online instructions without
clinical supervision, as only two participants (4.4%) reported experiencing negative
emotions (pity and sadness) while trying to feel compassion. Contrary to concerns that
people who were highly self-critical might show adverse responses, the higher self-critics
showed the largest improvements. Similarly, in Krieger et al.’s (2016) pilot study only
four participants (10.3%) experienced negative emotions (sadness and shame) during
the programme—but the three people who felt sadness said that this then helped them
to become more self-compassionate. In the subsequent randomised trial, four
participants (6.8%) in the compassion group experienced negative emotions during the
intervention (loneliness, impatience, anxiety, sadness and emotional instability), most of
1 Krieger et al. (2016) and Krieger et al. (2018) investigated an online version of the
‘Mindfulness-Based Compassionate Living’ programme, which, although not explicitly based on CFT,
also uses Gilbert’s (2010) theoretical framework of three aﬀect regulation systems.
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which were perceived as transient (Krieger et al., 2018). These ﬁndings suggest that
compassion-based self-help interventions can be used with few adverse eﬀects for
participants.
Compassion self-help for skin conditions
In addition to the Kelly et al. (2009) study that was included in Muftin and
Thompson’s (2013) review, four studies have investigated compassion-based self-help for
people with skin conditions to date. Muftin, Gilbert, and Thompson (2018) compared
the use of compassionate imagery and soothing breathing self-help materials with
people with psoriasis. Depression was not measured, but both interventions were
eﬀective in reducing shame over four weeks. Hudson (2015) later compared the soothing
breathing self-help with a wait list control among people with heterogenous skin
conditions, ﬁnding that the soothing breathing led to reduced depression two weeks
later. Similarly, a recent study found that, compared to an expressive writing control, a
single-dose compassionate writing intervention led to immediate improvements in
negative aﬀect in people with visible skin conditions (Sherman, Roper, & Kilby, 2019).
In contrast, D’Alton et al. (2019) found that a self-help version of mindfulness-based
self-compassion therapy had no signiﬁcant eﬀect on depression over eight weeks among
people with psoriasis. However, neither of the other interventions in this study
(mindfulness-based cognitive therapy and mindfulness-based self-compassion therapy)
were eﬀective for depression, contrary to expectations, and the authors suggested that a
ﬂoor eﬀect may have prevented signiﬁcant results from any of the interventions. Despite
this, participants reported ﬁnding all of the interventions satisfactory and beneﬁcial,
and that they would recommend them to others. Overall, evidence suggests that
compassion-based techniques hold promise as a self-help treatment for depression in
people with skin conditions, but that further research is needed.
One key area for futher research is intervention development. In the studies that
tested the eﬀects of compassion self-help on depression (D’Alton et al., 2019; Kelly et
al., 2009; Hudson, 2015), the interventions suﬀered from a number of shortcomings.
Firstly, D’Alton et al. (2019) excluded people with suspected depressive disorders,
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which may have led to a ﬂoor eﬀect, and the authors suggested that future studies
consider only including participants who score above clinical cutoﬀs on psychopathology
measures. Secondly, Kelly et al.’s (2009) self-soothing intervention comprised
compassionate imagery, letter writing and self statements over only two weeks. It is
possible that a multi-component compassion intervention cannot aﬀect depression in so
short a time, as participants have not had the chance to practise any of the techniques
suﬃciently. Thirdly, participant retention and adherence to the intervention were lower
than expected in Hudson’s (2015) study. The self-help booklet, while designed for
people with skin conditions, focused on appearance-related distress and did not mention
other common impacts of skin conditions, such as pain, itch, treatment burden and
restriction of valued activities. Only 35% of participants agreed that they would
recommend the self-help materials to a friend or family member, which indicates that
there is scope to improve the materials themselves. In addition, one of the problems
noted in the study was that some participants had trouble accessing the materials. This
was resolved by putting the materials online, but this only happened towards the end of
recruitment and so may have reduced participant engagement in the study.
The Current Study
The Medical Research Council (MRC) recommends the use of feasibility studies as
part of a systematic approach to developing, evaluating and implementing complex
interventions (Craig et al., 2008). Feasibility studies are preliminary pieces of research
that aim to explore certain aspects of the intervention that will inform future clinical
trials (Arain, Campbell, Cooper, & Lancaster, 2010; Donald, 2018). As such, feasibility
studies can have many diﬀerent aims, depending on existing research, such as exploring
acceptability or testing viability of the study protocols. The MRC also recommends
that feasibility studies focus on issues relating to the development of the intervention,
rather than outcomes (Craig et al., 2008). The current study will seek to build on
previously researched compassion-based self-help interventions for people with skin
conditions (D’Alton et al., 2019; Hudson, 2015; Kelly et al., 2009), by addressing their
limitations of including only participants who were not depressed, using self-help over a
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short (two-week) intervention period, and using self-help materials that were diﬃcult to
access and not perceived as acceptable to many participants. The study will therefore
investigate an online self-help intervention with email guidance with people who are
experiencing depressive symptoms. Based on the researcher’s clinical experience of
providing guided self-help to people with depression, it was decided that the
intervention in the current study would be six weeks in duration. It is hoped that a
six-week intervention will strike a balance between allowing time for participants to
learn and practice a number of diﬀerent techniques, and limiting participant burden and
attrition. The self-help exercises in the current study will consist of a number of
exercises derived from CFT/CMT (Gilbert & Irons, 2005; Gilbert, 2010), such as using
soothing rhythm breathing, compassionate imagery and compassionate writing.
Aims
The study aims to explore whether the online compassion-based guided self-help is
perceived as acceptable to people with heterogeneous skin conditions, in terms of
retention rates and explicit feedback. The study also aims to investigate the feasibility
of providing online compassion-based self-help and email guidance. Changes in
depression, self-compassion and skin-related distress will be assessed to give an estimate
of likely eﬀect sizes for future research.
Acceptability and feasibility criteria
Acceptability of intervention overall: The percentage of eligible participants who
access the webpages will be calculated using Qualtrics data and user logins to the
website. The intervention will be considered acceptable if at least 66% of eligible
participants log into the website during their sixth week of the study. This criterion was
chosen as a recent meta-analysis of computerised CBT for depression and anxiety
disorders reported a median retention rate of 66% (Andrews et al., 2018).
Feasibility of providing online self-help: All eligible participants should be able to
access the website, so if less than 90% of eligible participants log into the website during
their ﬁrst week of the study, this may suggest that there were problems with accessing
the self-help website. This criterion was chosen as more than one in ten people having
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diﬃculty accessing the website is analogous to experiencing a ‘very common’ side eﬀect
of a medication (NHS, 2018). User logins for subsequent weeks of the intervention will
also be recorded.
Feasibility of providing guidance: Researcher time spent providing email guidance
will be recorded, and will be considered feasible if this takes 120 minutes or less per
patient over the study period. This criterion is derived from guidance on individual
guided self-help interventions for people with depression, which typically consist of up
to 240 minutes overall (up to eight sessions at 30 minutes each; NICE, 2010; National
IAPT Programme, n.d.): if providing email guidance takes over half the amount of time
needed for individual guided self-help programmes, then it cannot reasonably be argued
to be “limited facilitation” (NICE, 2010, p. 23). The percentage of participants who
requested additional support via email will also be recorded. These ﬁgures will inform
future trials and implementation of guided self-help for people with skin conditions
within health services.
Method
Design
Given that the current study aims to investigate a novel intervention, the study
will be an acceptability and feasibility study that uses a pre–post design.
Participants
Participants will be adults who are currently living with a skin condition and who
are experiencing symptoms of depression, as identiﬁed by scoring 10–20 on the
depression subscale of the Depression Anxiety Stress Scales (DASS; Lovibond &
Lovibond, 1995), which represents mild–moderate levels of depressive symptomatology.
The stepped care model expects that people with mild–moderate depression will beneﬁt
from guided self-help (NICE, 2009), whereas people with more severe depression may
require more intensive interventions. Participants will be recruited online, in line with
the format of the intervention. The following skin charities/organisations have already
agreed to advertise the study on their websites and/or their social media channels when
ethical approval has been granted:
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• British Skin Foundation
• British Association of Dermatologists
• DEBRA (epidermolysis bullosa)
• Lupus UK
• National Eczema Society
• Pem Friends (pemphigus and pemphigoid)
• Psoriasis Association
If it is necessary to recruit more participants after skin condition organisations
have advertised the study, email advertisements will be sent to an existing volunteer list
from a previous study (E. Clarke, Thompson, & Norman, 2019), to members of the
University of Sheﬃeld’s volunteers lists, and to students at Sheﬃeld Hallam University’s
Psychology department. Snowball sampling will be used, where potential participants
will be asked to forward the study advert to family and friends who might be interested
in participating.
Inclusion criteria
• Self-reported as currently experiencing a skin condition that has been diagnosed
by a medical professional.
• Scored between 10 and 20 (inclusive) on the depression scale of the DASS at
baseline.
• Age 18 or over.
• Suﬃcient English language ability to read self-help materials and complete
self-report questionnaires.
Exclusion criteria
• Currently having psychological treatment for a mental health condition.
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• Diagnosis of a serious mental illness (e.g. bipolar disorder or psychosis).
• Diagnosis of a drug/alcohol addiction.
Procedure
Data will be collected using Qualtrics, an online survey provider. In the study
advert, participants will be provided with a link to the Qualtrics survey page, where
they will read the participant information sheet and complete an online consent form
(see Appendices A and B). Screening questions relating to the exclusion criteria will be
asked before participants complete the demographic questions, clinical information, and
baseline measures (see Appendices C–H). Baseline DASS depression scores will be
calculated automatically by Qualtrics. Any participants who disagree with the consent
statement or who are ineligible for the study will be re-directed to an ‘end of study’
webpage. This will explain that they are not able to continue with the study and
recommend that they contact their GP if they need further support. Signposting
information about mental health resources and emotional support for skin conditions
will also be provided to all participants.
Qualtrics will notify the lead researcher when an eligible participant has
completed the baseline survey. Eligible participants will be registered as users on the
study website by the researcher and then sent an email with their login details and a
link to the study website, with instructions to access the ﬁrst session of the
intervention. Anyone that attempts to access the intervention webpages without logging
in will be redirected to the login page—the only exceptions to this are the homepage
and the contact page. Requiring participants to log in means that engagement with the
intervention can be monitored without involving any third parties for website traﬃc
statistics (for example, Google Analytics), and also means that each participant’s use of
the website can be accurately tracked no matter what devices they use. At the end of
the ﬁrst session, participants will be asked to provide feedback on the ﬁrst session,
which will be collected using Qualtrics. Participants will receive an automated email
three days after completing the baseline measures to remind them to practise the
homework exercise (or go through the session if they haven’t already done so). One
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week after completing the baseline measures participants will receive an automated
email inviting them to access the second session of the intervention. Automated emails
will continue to be sent in this way, with homework reminders and links to subsequent
sessions. The emails will also invite the participant to contact the researcher if they
require further support with the self-help materials. The researcher will respond to any
such emails individually. One week after the last session participants will be invited to
provide feedback via Qualtrics about the guided self-help intervention overall, and to
complete the outcome measures again.
Intervention
The guided self-help intervention will consist of six online sessions of self-help
information for participants to work through, plus activities to carry out in-between
sessions. The intervention will consist of psycho-education material, self-monitoring,
and compassion-inducing exercises from CFT (Gilbert, 2010). The self-help exercises in
the intervention will be evidence-based as being eﬀective for depression: the
compassion-focused imagery exercises will be those used by McEwan and Gilbert (2016)
and the letter-writing exercise will be based on the one used by Shapira and Mongrain
(2010). Other exercises, such as thought monitoring and relapse prevention planning,
are commonly used in CBT and, as CFT is an adapted form of CBT, will be included in
the current self-help intervention. The session content and homework exercises will
build on previous sessions and homework, so there will be a clear sense of progression
through the intervention. In addition, imagery and written homework exercises will be
alternated, to provide variety and keep participants engaged in the intervention.2 A
breakdown of the intervention is shown in Table 1. Examples relating to skin conditions
will be given throughout the self-help materials.
Expert feedback regarding the content of the website has been sourced through
personal contacts and social media. Feedback has already been gathered from three
people with skin conditions. Changes to the website deemed necessary based on their
2 Some participants may struggle with imagery exercises (Naismith, Mwale, & Feigenbaum, 2018) while
others may prefer imagery to written exercises. Alternating these types of homework task ensures that
participants are never asked to do their less-preferred type of task for two consecutive weeks.
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feedback have been made (see Appendix K for anonymised email exchanges with expert
patients). In addition, a clinician with expertise in CFT has agreed to provide feedback
on the intervention, and any minor amendments (e.g. re-phrasing items) recommended
to keep the intervention in line with CFT principles will be made. The Psychology
DESC will be informed if any substantial amendments (e.g. changes to the format of
the intervention) are recommended.
Measures
Demographics.
As part of the baseline measures, participants will be asked to
provide demographic information about their age, gender, ethnicity, country of
residence, employment status and education level.
Clinical information.
Participants will be asked to state the name of their
skin condition(s) and how long they have had the condition. Participants will also be
asked to indicate whether they are currently taking any medication for a mental health
condition, and if ‘yes’, what medication(s) they are taking and how long they have been
taking it.
Acceptability measures.
Overall acceptability: At the end of the intervention,
participants will be asked to provide feedback via Qualtrics about which aspects of the
intervention were helpful or unhelpful for them and if they can identify any areas for
improvement. Open questions with spaces for text responses will be used to collect this
feedback, as well as an adapted version of the ‘Friends and Family Test’ used in the NHS
(see Appendix J). In line with recommendations that internet interventions monitor
negative eﬀects (Rozental et al., 2014), participants will also be asked whether the
intervention exacerbated any existing symptoms or caused any novel symptoms to arise.
Acceptability of intervention components: Participants will be asked for their
feedback on each weekly session of the intervention. Weekly feedback measures avoid
retrospective bias and responses will be used to identify helpful/unhelpful aspects of the
self-help intervention for further intervention development. Likert scales will be used to
ask participants for feedback on the usability of the webpage and the impact of the
self-help session. Relevant items from the Website Evaluation Questionnaire (Elling,
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2012) and the Session Impacts Scale (Elliott & Wexler, 1994) will be adapted to form
these Likert scales (see Appendix I). In addition, participants will have the opportunity
to make other comments on the weekly sessions via open text responses. Self-reported
adherence to the homework exercises will not be assessed, as the activities will diﬀer
from session to session, so it will not be possible to calculate overall adherence with the
homework exercises.
Outcome measures.
The depression subscale of the DASS (DASS–DEP;
Lovibond & Lovibond, 1995) will be used to measure participants’ levels of depression.
This consists of 14 items. Participants are asked to rate how much statements applied
to them over the past week on a four-point scale from ‘did not apply to me at all’ (0) to
‘applied to me very much, or most of the time’ (3), for example, ‘I couldn’t seem to
experience any positive feeling at all’. Higher scores indicate higher levels of depression.
Internal consistency of the DASS–DEP is excellent, with Cronbach’s alpha of .95
(Crawford & Henry, 2003).
The Self-Compassion Scale (SCS; Neﬀ, 2003) is a 26-item scale that will be used
to measure participants’ levels of self-compassion. Participants are asked to rate how
often they behave in the manner described in the statements on a ﬁve-point scale from
‘almost never’ (1) to ‘almost always’ (5), for example, ‘When I’m going through a very
hard time, I give myself the caring and tenderness I need’. Half the items are negatively
worded, and the total self-compassion score is obtained by reverse coding the negative
items. Higher scores indicate higher levels of self-compassion. The SCS has been shown
to have excellent internal consistency, with a Cronbach’s alpha of .93 (Neﬀ& Pommier,
2013). The SCS can also be used to give subscale scores for its six components:
self-kindness, self-judgement, common humanity, isolation, mindfulness and
over-identiﬁcation. The subscale scores have acceptable internal consistencies, with
Cronbach’s alphas between .75 and .81 (Neﬀ, 2003).
The Dermatology Life Quality Index (DLQI; Finlay & Khan, 1994) will be used to
measure the impact of participants’ skin conditions. Participants are asked to rate how
much their skin condition has aﬀected diﬀerent areas of their life over the last week on a
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four point scale from ‘not at all/not relevant’ (0) to ‘very much’ (3), for example, ‘Over
the last week, how much has your skin aﬀected any social or leisure activities?’ Higher
scores indicate more impaired quality of life. A review of studies that used the DLQI
found Cronbach’s alpha ranged from 0.75 to 0.92 (Basra, Fenech, Gatt, Salek, & Finlay,
2008).
Data analysis strategy
Text responses from participants’ feedback on the intervention overall will be
analysed using content analysis to identify helpful aspects of the intervention and areas
for improvement.
Quantitative data (outcome measures and acceptability ratings) will be screened
for outliers and missing values, and descriptive statistics will be conducted for all
variables. The data will be tested for the assumption of normality. Paired t-tests will be
used to test for diﬀerences in participants’ psychological outcome measures before and
after the intervention. This information will also be used to calculate eﬀect sizes (dz)
for changes in scores on each outcome measure. Intention-to-treat and completer
analyses will be carried out.
Sample size
Although all clinical trials require sample size justiﬁcation, formal sample size
calculations are not necessarily appropriate for feasibility trials (Billingham, Whitehead,
& Stevens, 2013). In this study, qualitative acceptability data will be used for further
development of the intervention as necessary. Quantitative data (such as feedback
ratings and changes in depression) will inform future research about the acceptability of
the intervention in its current form and provide an estimate of the eﬀect size for
depression. A minimum sample size of 12 can be justiﬁed based upon precision of the
estimates to be used in future research (Julious, 2005), although extra participants need
to be recruited to allow for attrition. A meta-analysis of internet-based CBT found that
attrition was 48% at the 75th percentile of studies (Andrews et al., 2018). To allow for
up to 48% attrition, it will be necessary to recruit 23 participants to provide the
minimum sample size of 12.
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The maximum sample size is dictated by the available resources to facilitate the
intervention. Based on clinical experience of providing email and telephone guidance to
patients undertaking cCBT, it is expected that providing email support will take
around 10 minutes per week per patient on average. Given the researcher’s working
pattern, up to nine hours per week could be allocated for directly facilitating the
intervention (approximately half of the researcher’s part-time hours). This leads to a
maximum of 54 ([9 x 60]/10) participants that can be provided with email support at
any one time. Although it would be possible to include more participants in the study
due to the rolling nature of recruitment, there are diminishing returns on the value of
increasing the sample size, as gains in the precision of estimates become less pronounced
(Hertzog, 2008; Julious, 2005). It therefore seems logical to set 54 participants as the
maximum sample size for the study.
Estimated timescale
A previous study of an online intervention for people with heterogeneous skin
conditions recruited 176 eligible participants over approximately three months (Hudson,
2015), using similar recruitment techniques. This equates to recruitment of 59
participants per month. The current study has one additional exclusion criterion
(mild–moderate level of depressive symptoms) compared to Hudson’s (2015) study, so
recruitment rates may be somewhat lower. Accordingly, it is expected that recruitment
will be completed within 6 weeks. In the current study it is hoped to recruit participants
primarily from skin condition charities/organisations so that university students are not
over-represented in the sample. However, if less than half of the minimum sample
required (n = 12) have been recruited three weeks after the study has been advertised
by skin condition organisations, the study will be subsequently advertised using the
researcher’s and the University of Sheﬃeld’s volunteer lists. Recruitment will be closed
after six weeks if the minimum sample size has been achieved or earlier if the maximum
sample size has been achieved. Once recruited, participants will remain in the study for
seven weeks (six weeks of the intervention plus follow-up one week later). It is therefore
expected that the study overall will be completed in 13 weeks.
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Ethical issues
Ethical approval.
The proposal, information sheet, consent form, measures
and intervention exercises for the current study will be sent to the University of
Sheﬃeld Department of Psychology Research Ethics Sub-Committee for approval
through the online ethics application system. In addition, the University of Sheﬃeld’s
research governance procedure will be followed, including completion of the ‘Risk
Assessment Checklist for University Sponsored Human-Interventional Studies’ and
public registration of the study on ‘ClinicalTrials.gov’.
Informed consent.
All potential participants will read an information sheet
(see Appendix A) and complete a consent form (see Appendix B) online prior to taking
part in the study. They will have the opportunity to ask the researcher any questions
about their participation in the study via email. The researcher’s email address will be
provided on the information sheet.
Participant withdrawal.
Participants will be able to withdraw from the study
at any point until their data are anonymised. Participants will be informed of this on
the information sheet and may contact the researcher by email to request that their
data is destroyed should they subsequently wish to withdraw from the study.
Eight of the guided self-help emails will be automatically sent from Qualtrics
based on completion of the baseline measures. If any participants contact the researcher
to withdraw from the study, that participant’s Qualtrics data will be exported (for ITT
analyses) and then the participant’s contact details will be deleted from Qualtrics so
that further automatic emails are not sent to that participant.
Adverse eﬀects.
As with all psychological interventions, there is a risk that
taking part in this study may raise participants’ awareness of pre-existing distressing
thoughts and feelings, leading to some distress during or after taking part in the study.
Participants will be made aware of this possibility prior to taking part in the study via
the information sheet (see Appendix A). The information sheet will also provide
participants with signposting information for mental health support (e.g. the
Samaritans) and advise them to speak to their GP if necessary. In addition, if
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19
participants advise the researcher of any adverse eﬀects via email, the researcher will be
able to re-iterate options for further support as appropriate. The researcher previously
worked in primary care mental health services for ﬁve years, providing guided self-help
to people with depression and anxiety disorders, and is therefore experienced in dealing
with emotional distress and signposting appropriately. If necessary, the researcher will
discuss concerns with her primary supervisor, who is a clinical psychologist.
Conﬁdentiality.
Participants will be informed that their data will be kept
conﬁdential and that they will not be personally identiﬁable in any results of the study.
Unique identiﬁcation numbers will be used throughout the data sets. A data ﬁle will be
created to contain participants’ details and their identiﬁcation numbers, for matching
up quantitative data over time and to allow the destruction of data should participants
wish to withdraw from the study. This data ﬁle will be password-protected and kept
separately from the rest of the participants’ data.
Spreadsheets containing participants’ names and email addresses will also be
created in order to administer the study—for sending emails on the correct dates and
tracking participants’ logins. No sensitive quantitative data will be kept in these
spreadsheets, only dates. These spreadsheets will also be password-protected and kept
separately from outcome measures and feedback data. Once data collection is complete,
participants’ names and email addresses will be replaced with their unique identiﬁcation
numbers.
Participants will be required to log into the study website solely to track user
logins for the purpose of monitoring participants’ engagement with the intervention
from week to week. Participants will log into the website with a username (usually their
ﬁrst name) and password that has been allocated to them by the researcher.
Participants will not be asked to provide any data via the study website, nor will they
be able to access any other participants’ details. No-one except the researchers involved
in the study will have access to participants’ contact details.
Data protection.
Personally identiﬁable digital data will be stored securely as
described above, on the lead researcher’s university ﬁlestore. The lead researcher will be
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20
the only person with administrator access to the study website. The study website is
hosted on the University of Sheﬃeld’s servers, and therefore participants’ contact
details (names and email addresses used to administer user memberships) that are
visible to the administrator on the study website will also be stored securely within the
university’s ﬁrewalls. Administrator access to the website is protected by requiring the
administrator to log in from within the University of Sheﬃeld’s virtual private network
(VPN) and uses two factor authentication, requiring a code accessed from the
administrator’s mobile phone. Wordfence, a Wordpress security plugin, is also being
used to provide protection from brute force attacks (malicious attempts to gain access
using repeated guesses at user names and passwords) on the frontend of the website.
Participants will be made aware of how their data will be protected in the information
sheet (see Appendix A).
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Table 1
Compassion-based self-help intervention for people with skin conditions
Session
number
Session content
Homework activity
1
Normalising the diﬃculties of living with
skin conditions. Explanation of the three
systems of emotions (threat/protection,
drive/excitement, and soothing systems)
and soothing system as regulator of
threat/protection system. Audio
recording (and text version) of soothing
rhythm breathing practice.
Practise soothing
rhythm breathing,
e.g., ﬁve minutes
daily.
2
Tricky brain explanation (emotions and
cognitive abilities). Vicious cycle of
thoughts and emotions. Example
thought record.
Notice self-criticism:
ﬁll in own examples
on thought record.
Continue breathing
practice.
3
Example of how emotional tone of
self-talk can aﬀect our feelings. Audio
recording (and text version) of
‘compassionate other’ imagery.
Practise
‘compassionate other’
imagery, e.g. ﬁve
minutes daily.
4
Compassionate writing instructions.
Example compassionate letter to oneself.
Write compassionate
letter (5–15 minutes).
5
Explanation of qualities of compassion
(wisdom, strength/authority, and
commitment). Audio recordings (and
text versions) of ‘building the
compassionate self’ imagery and
‘addressing self-criticism’.
Practise
‘compassionate self’
imagery, e.g. ﬁve
minutes daily.
6
Explanation of why a written relapse
prevention plan (summary of learning
points) is helpful. Example relapse
prevention worksheet.
Complete relapse
prevention worksheet.
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