Piloting an Intervention Using Single Case Design to Reduce Uncertainty Distress in Those With Long Term Health Conditions
Phase: NA
Conditions: Rheumatic Diseases
Sponsor: Newcastle University

Protocol V1.3 04/02/22 
 
IRAS:293383 
 
 
 
Project Protocol 
Piloting an intervention using single case design 
to reduce uncertainty distress in those with long 
term health conditions. 
 
Version 1.3 04/02/2022 
 
 
 
 
 
 
HRA Protocol Compliance Declaration: 
This protocol has regard for the HRA guidance  
 

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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that 
the Chief Investigator agrees to conduct the study in compliance with the approved protocol 
and will adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, 
and other regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be 
used for any other purpose other than the evaluation or conduct of the investigation 
without the prior written consent of the Sponsor 
I also confirm that I will make the findings of the study publicly available through publication 
or other dissemination tools without any unnecessary delay and that an honest accurate 
and transparent account of the study will be given; and that any discrepancies from the 
study as planned in this protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
....../....../...... 
Name: (please print): 
...................................................................................................... 
 
 
 
 
 
 

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LIST OF CONTENTS 
 
 
 
 
Contents 
Page 
Number 
Title page 
1 
HRA protocol compliance declaration  
1 
Signature page 
2 
List of contents 
3 
Study Key contacts 
4 
Project timetable (Gantt Chart) 
5 
SECTION/CHAPTER 
 
1. Background 
6 
2. Rationale 
8 
3. Research Questions/Aims 
10 
4. Study Design/Methods 
10 
5. Sample and recruitment 
16 
6. Ethical and regulatory compliance 
19 
7. Study safety reporting (Adverse Events and Serious Adverse 
Events)
26 
8. Research Costs 
27 
9. Dissemination policy 
27 
10. References 
28 
11. Appendices 
33 
 
 
 
 

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STUDY KEY CONTACTS 
Chief Investigator:  
Sarah Kay, Trainee Clinical Psychologist (s.kay2@newcastle.ac.uk)  
Project Supervisors:  
Professor Mark Freeston, Professor of Clinical Psychology Newcastle University 
(mark.freeston@newcastle.ac.uk)  
Dr Lauren Mawn, Clinical Psychologist, Newcastle Upon Tyne Hospitals NHS 
Foundation Trust (l.mawn@nhs.net).  
Dr Helen Aylott, Clinical Psychologist, Newcastle Upon Tyne Hospitals NHS 
Foundation Trust (Helen.Aylott@nhs.net) 
  
Project Sponsor:  Cumbria, Northumberland Tyne and Wear NHS Foundation Trust 
 
Contributors: Gemma O’Callaghan, Occupational Therapist, Rheumatology, 
Newcastle Upon Tyne Hospitals NHS Foundation Trust 
 
 
 
 
 
 
 
 

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PROJECT TIMETABLE  
Jan 
2021 
Feb 
2021 
Mar 
2021 
Apr 
2021 
May 
2021 
June 
2021 
July 
2021  
Aug 
2021 
Sept 
2021 
Oct 
2021 
Nov 
2021  
Dec 
2021 
Jan 
2022 
Feb 
2022 
Mar
2022 
Apr
2022 
Preparing 
research 
protocol 
Regulatory 
approval 
(IRAS, REC, 
HRA) 
Participant 
Recruitment 
Conduct 
Research 
Data Analysis
Draft Report
Editing
Final Report
  

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1. 
BACKGROUND 
A large amount of people experiencing long term physical health conditions have 
comorbid anxiety and depression (Naylor et al, 2012). Traditionally they receive 
support and care for their physical and mental health needs in separate services 
that are rarely coordinated. This has been identified as ‘’ inconvenient for patients, 
costly to the NHS, and likely to produce sub-optimal outcomes’’ (National 
Collaborating Centre for Mental Health, 2018, p 3.) The NHS has recently 
established long term conditions pathways within existing IAPT services ensuring 
co-ordinated care for those with comorbid physical and mental health problems. 
 
The National Institute for Health and Clinical Excellence (NICE) recommends 
Cognitive Behaviour Therapy (CBT) in the treatment of a number of long-term health 
conditions including Chronic Fatigue, IBS and chronic lower back pain (NICE, 2007, 
2008, 2016). CBT applied to health problems focuses on helping people manage 
symptoms and improve quality of life. Cognitive interventions typically focus on 
modifying a person’s unhelpful or inaccurate negative thoughts about their illness, 
symptoms and its impact on daily living. Behavioural interventions focus on teaching 
pacing skills, reducing maintaining behaviours including monitoring and checking 
and overcoming avoidance of situations. 
 
It has long been established that uncertainty is a natural component of both acute 
and chronic illness (Mishel, 1990). Illness uncertainty is defined as ‘’the inability to 
determine the meaning of illness-related events’’ (Mishel, 1988 p. 225) Sources of 
uncertainty in chronic illness involves living with ambiguous symptoms, 

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unpredictability of flare ups, if/when the illness will worsen and whether and how 
effective treatment will be (McCormick, 2002). Whilst some real-world uncertainty is 
inevitable in illness, perceived uncertainty can be exacerbated by inconsistent 
and/or inadequate information given by health professionals on how to manage 
health conditions. (McCormick, 2002).  
 
Humans typically find states of uncertainty aversive (Carlton, 2012) and research 
has suggested that they prefer to resolve uncertainty even when the outcome will 
be unpleasant (Hsee & Ruan, 2016). However, some individuals are better able to 
cope with uncertainty than others. Intolerance of Uncertainty (IU) has become a 
widely recognised phenomenon which is thought to be a dispositional trait reflecting 
negative beliefs about uncertainty and its consequences across situations (Dugas & 
Robichaud, 2007). It has also been recognised as a situation specific source of 
distress in emotional disorders (Mahoney & McEvoy, 2012). IU has been identified 
as a core trans-diagnostic feature underlying multiple emotional disorders (McEvoy 
et al, 2019). CBT interventions for Generalised Anxiety Disorder specifically 
targeting IU have been developed (Dugas & Ladoucer, 2000, Dugas & Robichaud, 
2007) and demonstrated to be effective in randomised controlled trials (Ladouceur 
et al., 2000; Dugas et al., 2010) and case series (Hebert & Dugas, 2019).  Further 
research has shown that targeting IU using transdiagnostic CBT treatment may be 
of benefit in both individual and group therapy. (Tiplady et al., 2017; Mofrad et al., 
2020) 
In health settings, high IU is associated with increased worry and anxiety about 
health (Rosen et al, 2010; Taha, Matheson, Cronin & Anisman, 2014).  Uncertainty 

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management interventions have been shown to improve patient’s knowledge of their 
condition, patient-health professional communication, mood and coping skills. 
(Mishel et al., 2005; Jiang & He, 2012). These interventions have been primarily 
concerned with reducing perceived illness uncertainty through informational 
interventions (Zhang, Kwekkeboom, Kim, Loring & Wieben, 2020). 
 
2. RATIONALE 
Until recently there has been very little research directly aimed at increasing 
tolerance of uncertainty in the health population. This is important given the amount 
of actual uncertainty people with chronic conditions experience.  Some recent 
research has shown promising results in directly targeting IU as one part of a 
treatment in those recently diagnosed MS to reduce uncertainty distress and 
improve acceptance of the health condition (Molton et al., 2019).   
To date there is no research combining informational interventions to reduce 
perceived illness uncertainty and interventions improving generic tolerance of 
uncertainty. The evidence base on these individual approaches would suggest that 
combining treatment elements targeting both actual and perceived uncertainty 
would lead to superior treatment outcomes for those with long term health 
conditions.  
Freeston, Tiplady, Mawn, Bottesi and Thwaites (2020) proposed a new theoretically 
driven model of uncertainty distress grounded in the separate literature bases of 
threat models of anxiety, illness uncertainty and intolerance of uncertainty. 
Uncertainty distress is defined as ‘’the subjective negative emotions experienced in 

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response to the as yet unknown aspects of a given situation’’ (Freeston et al, 2020 
p 2)  
Figure 
1: 
Model 
of 
uncertainty 
distress 
(Freeston 
et 
al 
2020)
The model comprises real world variables of ‘Actual Threat’ (what is known) and 
‘Actual Uncertainty’ (what is not/cannot yet be known) with psychological factors at 
a situational and dispositional level. Psychological factors include perceived threat, 
perceived uncertainty and the ability to tolerate uncertainty.  
The model outlines a trans-diagnostic treatment intervention comprising information 
management strategies, building safety, addressing overestimation of threat and 
developing tolerance of uncertainty (Freeston, 2020). 
  
The potential benefits from this research to the NHS are the development of a new, 
better treatment for those with long term health conditions and associated distress. 
The treatment can be delivered in a single health care setting which can bridge the 
gap between physical health and mental health care needs. The impact of this 
treatment has the potential to reduce disease distress and burden. In addition, it may 

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have benefits on reduced health care utilisation if patients are managing their health 
condition, emotional impact of health condition and uncertainty better.  
 
3. 
RESEARCH QUESTION AND AIMS  
The aim of this research is to develop and pilot a treatment intervention which is able 
to target perceived illness uncertainty (PIU) and intolerance of uncertainty (IU) in 
individuals experiencing distress in the context of a long-term health condition who 
are seen by the multi-specialty service within Psychology in Healthcare in Newcastle 
Upon Tyne Hospitals (NUTH) NHS Foundation Trust.  
Hypothesis:  
Treatment intervention targeting PIU and IU will effectively reduce uncertainty 
distress in those with a long-term health condition.  
 
4. STUDY DESIGN/METHODS 
4.1  Study Design 
A multiple baseline (MBD) single-case experimental design (SCED) will be used. 
Baselines will be systematically staggered between participants ranging from a 
minimum of 14 days to a maximum of 28 days. This ensures familiarisation with 
completing the daily measures and sufficient data points in the baseline phase to 
establish stability.  

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Monitoring specific targets prior to introduction of treatment allows for control to 
reduce the likelihood that any changes can be attributed to factors other than 
treatment (Morley, 2018, p 66). 
Design will be an ABCD design which will be as follows 
A- Baseline  
B- Novel treatment intervention  
C- Monitoring 
D- Follow-up.       
The methodology will be a within subject design with repeated measures on multiple 
target variables.  
4.2 Measures 
4.2.1 Primary Outcome Measure: Daily Diary: 
Idiographic target problems will be identified by the participant at the assessment 
session and prior to the beginning of the baseline phase of the study.  Idiosyncratic 
statements (which may include salient items from standardised measures) will be 
co-constructed by research therapist and participant which will relate to perceived 
illness uncertainty, intolerance of uncertainty and health condition symptomatology. 
Statements will be constructed in line with guidance produced by Freeston and 
Thwaites (2014). These statements will be rated daily by the participant on a Likert 
scale and will be referred to as ‘’daily diaries’’.  
 

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An example could be ‘’Because I am uncertain how bad my pain will be I find it 
difficult to decide what I can do today?’’ rated as ‘Strongly Agree’, ‘Agree’, ‘Neutral’, 
‘Disagree’ or ‘Strongly Disagree’.  
Daily diaries will be completed via ‘Qualtrics’ online survey software. Paper versions 
will be made available to those who prefer to complete measures in this form.  Daily 
diary measures will be completed each day throughout the study from baseline 
phase to follow up.   
As the design of the study is contingent on the completion of daily diary measures 
this will be explicitly discussed during the information giving and consent processes 
to allow participants to make an informed decision as to whether they can commit to 
completing the diaries. In order to enhance completion daily text message reminders 
will be sent to participants- for those who are completing the diaries via Qualtrics a 
link to the Qualtrics programme will be included in the text reminder.   The time of 
the day that the text reminder will be sent will be agreed on an individual basis to 
ensure maximum likelihood that this prompt will be at a convenient time for the 
individual to complete the daily diaries. 
Previous research studies using daily diaries as target measures in single case 
experimental design to target intolerance of uncertainty have obtained high levels of 
data completeness (Tiplady et al., 2017; Bentley, 2020). If individual participants 
have low completion rates then this will be discussed in the therapy sessions with 
the participant to ascertain the barriers to completion and where necessary changes 
made to enhance likelihood of completion –for example change the time that text 
reminders are sent so it is more convenient for the participant.   

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4.2.2 Secondary Outcome and Benchmarking measures. 
Benchmarking and phase change measures will be completed via ‘Qualtrics’ or in 
paper format if requested. 
Standardised mood measures will be completed at each session as is routine in 
psychological therapy services (The National Collaborating Centre for Mental 
Health, 2020)  
 
These will be: 
Patient Health Questionnaire 9 (PHQ-9): a reliable and validated measure of 
depression severity (Kroenke, Spitzer & Williams, 2001).  
Generalised Anxiety Disorder 7 (GAD-7): a reliable and validated measure of 
generalised anxiety disorder severity (Spitzer, Kroenke, Williams & Lőwe, 2006). 
 
4.2.3 Phase change measures: 
Additional measures will be administered at the beginning of each phase and at mid-
point in intervention phase (B). These questionnaires relate to the key constructs in 
the theoretical model.     
 Perceived Illness Uncertainty: Mishel Uncertainty in Illness Scale- 
Community Form (MUIS-C, Mishel and Epstein, 1997)  

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 Intolerance of Uncertainty: Intolerance of Uncertainty Scale 12 (IUS-12, 
Carleton, Norton & Asmundson, 2007)  
 Intolerance of Uncertainty Behaviours: Intolerance of Uncertainty Behaviours 
in Everyday Life Questionnaire (IUBEL, Clifford et al., 2015) 
 Threat:  Brief Pain Inventory (BPI) a validated measure of chronic pain (Tan, 
Jensen, Thornaby & Shanti, 2004) 
 Life Disruption: Measure of the impact of disease on daily functioning   
In addition the International Adjustment Disorder Questionnaire (Shevlin et al., 2020) 
will be used as a pre and post measure.   
See Appendix A for copies of measures. 
4.3 Treatment Intervention:  
Please see Appendix B for overview of treatment phases, interventions within the 
phase and duration of each phase. 
 
Treatment intervention will be based on uncertainty distress model (Freeston et al, 
2020) and will be a semi- standardised manual format. The manual will be developed 
by the researcher building upon the work of the Newcastle IU Treatment 
Development Group and the UNcertainty in COronavirus Research Network 
(UNiCORN), both expert groups of clinicians and researchers.  
 

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Treatment sessions will be up to 60 minutes and delivered on an individual basis by 
qualified therapist(s). Sessions will be delivered either face to face in a hospital 
setting or video-call through NHS trust approved systems.   
 
Treatment will comprise of 4 modules as based on the treatment model presented 
in Figure 1 above. These will be: 
1. Building Safety (Life Disruption) 
2. Managing Information 
3. Reducing perceived Threat 
4. Reducing intolerance of Uncertainty 
 
Participants will complete between 1 and 4 sessions on each module depending on 
clinical need guided by their assessment and formulation. Treatment duration will be 
a maximum of 16 sessions.  Therapists will complete a checklist at the end of each 
session to indicate which parts of the treatment intervention were covered in the 
session. Please see Appendix C for Treatment Fidelity Checklist developed by Parr 
et al. (2020) which will be adapted specific for this intervention.   
 Participants will be asked to consent to the video recording of treatment sessions 
to be reviewed by members of the research team for the purpose of ensuring quality 
of treatment and adherence to the treatment protocol. If a participant does not 
consent to the video recording of sessions then they can still be included in the 
study.  Consent to video-recording will be captured on the consent form. 

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In addition to being asked to consent to video-recording of the session on the 
consent form, this will be reviewed at each treatment session. It is made explicit in 
the PIS that a participant can request that a recording can be stopped at any point 
and deleted. Ongoing consent to video record sessions will be recorded in the 
clinical notes along with any requests to stop recording individual sessions. Consent 
to recording individual sessions or declining the recording of sessions will be 
recorded on the clinical record of the participant for each session.  
 
 A proportion of the recorded treatment sessions will be watched and rated by a 
member of the research team using the treatment fidelity checklist (Appendix C). 
The therapist and raters’ checklists will then be compared to establish fidelity to 
treatment model. All recordings will be deleted at the end of the study. 
  
 To evaluate the treatment’s credibility and satisfaction, participants will be given a 
feedback questionnaire to complete. This will be based on those used in previous 
programmatic Intolerance of Uncertainty research projects (Bentley et al 2020) 
Please See Appendix D. 
 
4.4 Data Analysis: 
Data analysis on primary outcome measures will use visual analysis which is 
traditional for quantitative single-case methodology (Morley, 2018, p 88).  Tau-U will 
be used to measure data non overlap between the phases using an online calculator 

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at http://www.singlecaseresearch.org/calculators/tau-u (Parker, Vannest, Davis and 
Sauber, 2011).   
 
4.4.1 Primary Outcomes: 
Data from daily diary measures will be plotted on a graph with the horizontal axis 
representing duration in days and the vertical axis representing numerical score on 
Likert scale. Phases will be clearly labelled separated from the next on the horizontal 
axis and indicated by a vertical line on the graph.  
The graph will be examined for level, trend, variability, immediacy of effect, overlap 
and consistency of pattern within phase which are considered to be the key features 
used to assess within- and between-phase data patterns (Kratochwill et al., 2010).   
 
Visual analysis will be initially carried out by the research team and then subsequent 
independent analysis carried out by a second rater.   
 
4.4.2 Benchmarking and phase change measures: 
These measures will be analysed for reliable and clinically significant change 
(Jacobson & Truax, 1991).  
Reliable change criteria are used to assess whether an individual’s scores on 
specific psychometric questionnaires between two time points (in this case pre and 
post treatment) change significantly more than would be expected due to 
measurement error of the questionnaire alone. A Reliable Change Index (RCI) is 

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computed by dividing the difference between the pre-treatment and posttreatment 
scores by the standard error of the difference between the two scores. (Jacobson 
and Truax 1991)  
Clinically significant change criteria are used to measure whether changes on 
specific psychometric questionnaires from pre-treatment to post-treatment are large 
enough to be considered to be clinically meaningful. It represents a change in scores 
which moves the person from the ‘clinical group’ (scores above the clinical cut off 
for a particular measure) to the ‘non-clinical group’ (scores below the clinical cut off 
for the measure. (Jacobson and Truax 1991) 
 
 
 
5.  SAMPLE AND RECRUITMENT 
5.1 Sample Size 
Replication will be sought across three to six participants. Three replications are the 
conventional minimum number to establish an effect (Morley, 2018 p 158). 
Recruiting up to six participants allows for attrition and to still meet the minimum 
number of 3 at the same time as ensuring as few participants as necessary are 
exposed to the novel treatment intervention.  
The number of participants will be determined by: 
a) pragmatic constraints including time available following ethical approval 

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b) participant recruitment  
c) number of therapists implementing the treatment protocol.  
 
5.2 Recruitment 
Participants will be initially recruited from the Rheumatology Department within 
Newcastle Upon Tyne Hospital Foundation NHS Trust. If the sample size is not 
reached within the Rheumatology Department, then recruitment will commence in 
the Gastroenterology Department. Participants will be those experiencing distress 
associated with the adjustment to their long-term health condition and those who 
would be referred to the Psychology in Healthcare Department for psychological 
intervention (treatment as usual). The healthcare team will be briefed of the purpose 
of the study and inclusion/exclusion criteria in order to identify potential participants. 
The healthcare team will then identify any potential participants in their routine 
consultations and introduce the research study and seeking expressions of interest 
to find out more about participating in the research. Verbal consent will be obtained 
to pass contact details to the research team and this will be recorded in the 
participants’ electronic medical record. Expressions of interest will be passed to the 
research team and potential participants will then be contacted and given verbal and 
written information (Participant information sheet) about the study.  
 
Participants will be screened by the research therapist(s) through a short interview 
process in line with eligibility criteria and using standardised questionnaires. Those 
who are screened who are not suitable for participation in the research trial will be 

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offered alternative psychological therapy for their difficulties via the multi-speciality 
psychology in health care team. This is ‘treatment as usual’ for patients experiencing 
difficulties adjusting to health problems. 
 
5.3 Consent        
Participants will be required to voluntarily give fully informed consent. They will be 
informed about the research through the participant information sheet (PIS) and will 
be given at least 48 hours to consider their participation and to discuss this will 
significant others.    Potential participants will be given the opportunity to discuss 
with any queries they may have or obtain clarity on any matter. Once they are 
satisfied that they are fully informed about the study the written consent form will be 
completed with the participant by the chief investigator. If participants have 
expressed a wish for remote delivery of treatment then an electronic consent form 
will be completed via Qualtrics.    
Participants will be informed that they can withdraw from the study at any point 
without having to give a reason.  
Consent to continue participation in the research study will be reviewed at each 
contact with the participant and documented on the session summary sheet and in 
clinical records.  
 
5.4 Eligibility Criteria 
5.4.1 Inclusion criteria 

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 Age 18- 65 
 Diagnosed long term health condition (Rheumatoid Arthritis,  IBS/IBD) 
 Minimum of 12 months since diagnosis of physical health condition 
 Difficulties adjusting to long term health problems.  
 Willingness to engage with psychological treatment to manage distress 
associated with their health condition.  
 Fluent English speaking 
5.4.2 Exclusion criteria 
 Under 18 or over 65 
 Multiple long term health conditions 
 Progressive long term health conditions 
 Experiencing mental health difficulties which may affect ability to engage with 
time-limited psychological therapy including diagnoses of Major Depressive 
Episode and/or severe and enduring mental health problems, comorbid 
substance misuse and suicidality.   
 Diagnosis of Autism Spectrum Disorders (ASD)  
 Non-English speaking   
 
5.5 Clinical Considerations  
Participants accessing treatment through the trial are those who would wait to 
access treatment through the Psychology in Healthcare department in the acute 
hospital setting or access treatment for their distress separately through mental 
health services.  Participants will be informed that whilst this treatment is based on 

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empirical evidence and an extension of previous treatment models targeting IU this 
specific treatment model is new. Participants will be informed that if they chose to 
withdraw at any time there will be an arrangement in place so that they can access 
their original place on the waiting list without penalty to receive usual care or be 
referred to access alternative treatment if they were not already on the waiting list.  
 
6. ETHICAL AND REGULATORY COMPLIANCE  
6.1 Regulatory Review 
An application will be made for Health Research Authority (HRA) and Research 
Ethics Committee (REC) approval involving submission of the protocol and all 
research documentation.   
6.2 Scientific Review 
The scientific quality of the project has been reviewed by an independent panel at 
Newcastle University. 
It has also been reviewed by experienced members of the research team and the 
project research supervisor. 
See Appendix E and F for the Ethics Grid and Diversity Grid required for approval 
by University.  
 6.3 Potential risks and Burdens  
6.3.1 Distress: 
As with any psychological therapy intervention there is the potential for it to be 
distressing to the participant when discussing their problems. However, this is no 

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greater than the potential for this to happen in alternative psychological treatment 
they would receive as usual. Participants will be advised of this in the participant 
information sheet.  The research therapists conducting the treatment are qualified 
CBT therapists with skills and experience working with people in distress and will 
help manage the distress in the session. The hope is that as with other psychological 
therapies, distress will reduce through the course of therapy. 
If distress does not reduce and mental health deteriorates during the course of 
therapy therapists will seek appropriate supervision and options would be discussed 
explicitly with the participant including withdrawal from the research and referral for 
additional/alternative support and treatment. 
6.3.2 Burden 
The main burden for participants is the time involved in participation in the research. 
From the start of baseline monitoring to follow up will be up to 25 weeks. During 
active treatment participants will be required to commit one hour per week for 
therapy sessions for up to 16 weeks, however this is no different from standard 
psychological therapy. Standardised questionnaire measures will be completed at 
various points during the treatment however this is standard practice for 
psychological therapies.  The additional burden arises as a result the time taken to 
complete daily diaries which are specific to the research project. Participants will be 
required to complete daily diaries for a maximum of 175 days of which these 
measures take approximately 5 minutes daily.   Participants will be informed of the 
likely time commitment required within the Participant Information Sheet (PIS) and 
will be able to make an informed decision whether they want to participate. They will 
be compensated for this time using a Wage Payment Model (Dickert & Grady, 1999) 

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reimbursing them for the time taken to complete measures in the form of vouchers - 
see section 6.4 Incentives and rewards below.  
6.3.3 Disclosures and discovery of information that may need acting upon: 
Whilst it is not anticipated there is a small chance that disclosure of information to 
or discovery of information by the therapist may need acting upon such as risks to 
self-and/or others. In the case of this occurring the research therapists will follow 
standard service protocols.  Participants will be explicitly advised at the start of the 
treatment intervention that if this were to occur that confidentiality would be broken. 
If it is safe to do so the participant will be advised that the information will be shared 
and with whom. The researcher will have access to contact details for participants 
GP, local Crisis Team, local social care duty teams. Support and advice will be 
sought from the clinical supervisor attached to the research project.  Research 
therapists are qualified CBT therapist who are skilled and experienced with dealing 
with such disclosures and discovery of information in their everyday roles.      
6.4 Incentives and Payment 
Potential benefits to participants from being part of the research is the opportunity 
to contribute to the development of a new treatment to help reduce distress 
associated with uncertainty of long-term health conditions. 
 
In order to mitigate the burden and time cost of completing daily diary measures, 
participants will be reimbursed for their time in vouchers. The amount will be 
calculated on a wage payment model (Dickert & Grady) based on the current 
minimum wage for the UK. Please see Appendix G for details.  

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It is estimated that completion of daily diaries will be around 5 minutes per day 
throughout the duration of the study (Up to 175 days). The study design is contingent 
on the completion of the daily diary entries and it is hoped that participants will 
complete them all. If completion of diaries is less than 100% the participant will be 
reimbursed the amount relevant to the time the participant has taken to complete 
the proportionate amount of diaries.     
Participants will be reimbursed in the form of e-vouchers at the end of the end of 
their participation in the study. In order to pay the e-vouchers, Newcastle University 
will require personal details (name and email address). This will be made clear in 
the PIS and this information will be treated in accordance with GDPR and Newcastle 
University policies and will be kept separate from other information provided for the 
research.   
 All payment monies have been agreed to be paid by Newcastle University, School 
of Psychology.  Participants can donate wage-payment to charity if they wish.  
 
 
 
6.5 Confidentiality:   
Personal identifiable data and sensitive clinical data will be recorded on the host 
NHS trust’s electronic record keeping system in line with NHS information 
governance policy including Data Protection Act (DPA) and The General Data 
Protection Regulation (GDPR).  

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Video recordings will be stored securely on Trust Approved Systems and will be 
accessed only by named members of the research team and will not be transferred. 
They will be watched for the purpose of supervision and ensuring quality of treatment 
and assessing treatment fidelity to the model. All videos will be deleted at the end of 
the research project.  
   
Data transferred from the NHS setting to the University will be done so anonymously 
using a unique participant identifier and stored on the University’s secure server. 
Daily diaries and phase changes measures will be completed via 'Qualtrics' a survey 
software package where each participant will be sent a link which they can access 
from their smart phone. No personal identifiable data will be held on Qualtrics. The 
research team will be able to access the responses from the Qualtrics programme. 
 
Personal identifiable information held by the University will be a contact telephone 
number to arrange appointments and send daily text reminders and an email 
address of the participant for the purpose of payment of voucher reimbursement for 
their participation. An email address or postal address will be held if the participant 
requests a summary of research findings. Participants will be informed that these 
details will be held by the University for these specific purposes only.    
   
All participants will be asked to choose a pseudonym for the purpose of writing up 
and disseminating results. Care will be taken that they will not be identifiable through 

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the combination of key demographic information – if there is a risk of this 
demographic data will be presented in broad categories or omitted.     
7. STUDY SAFETY REPORTING (ADVERSE EVENTS AND SERIOUS ADVERSE 
EVENTS) 
All adverse events will be reported to the Principle Investigator who will then assess 
each event for causality, seriousness and expectedness.  Adverse events that are 
not assessed as serious ( AE’s) will be recorded in the participant’s electronic clinical 
record and documented in the investigator site file. Adverse events that are 
assessed as serious will be reported to the Chief Investigator immediately or within 
24 hours of the Principle Investigator becoming aware of the event. The Principle 
Investigator will complete the Serious Adverse Events form and send via email to 
the Sponsor as soon as possible after being made aware of the event. The Principle 
Investigator will also report serious adverse event through the Host NHS Trust’s 
internal incident reporting system.  Safety reporting will be completed in line with the 
Sponsor NHS Trusts Standard Operating Procedure for Safety reporting of Adverse 
Events and Serious Adverse Events.    
8. RESEARCH COSTS  
Costs incurred in this project will be the wage-payment vouchers as compensation 
for time completing daily measures and text message reminder service. All costs will 
be covered by the Doctorate in Clinical Psychology and have already been agreed. 
See Appendix H for costing grid.  
9. DISSEMINATION POLICY 

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This research will be disseminated within the University of Newcastle as part of the 
requirements for the award of Doctorate in Clinical Psychology. The research will be 
presented at an appropriate research conference and written up for publication in a 
peer reviewed journal.  
 
 
 
9. REFERENCES 
 
Bentley, A. (2020) Sitting with Uncertainty: Developments in a Transdiagnostic 
Intervention Targeting Intolerance of Uncertainty and Examination of Change 
Process.  Unpublished doctoral thesis, Newcastle University, Newcastle 
Upon Tyne, UK.  
 
Carleton, R.N., (2012). The intolerance of uncertainty construct in the context of 
anxiety disorders: Theoretical and practical perspectives. Expert review of 
neurotherapuetics, 12,  937-947.  
Carleton, R.N., Norton, M. P.J., & Asmundson, G.J. (2007). Fearing the unknown: A 
short version of the Intolerance of Uncertainty Scale. Journal of anxiety 
disorders, 21(1), 105-117.  
Clifford, M., Hardcastle, R., Lambert, E., Beckwith, H., Bottesi, G., Wilkins, F., 
Mclean, F., & Freeston, M. (2015) Development of a measure of Intolerance 
of Uncertainty Behaviours in Everyday Life (IUBEL). Technical report 
available from mark.freeston@ncl.ac.uk, Newcastle University. 
Dickert, N., & Grady, C. (1999). What’s the price of a research subject? Approaches 
to payment for research participation. The New England Journal of Medicine, 
341, 198-203.  
Dugas, M. J., Brillon, P., Savard, P., Turcotte, J., Gaudet, A., Ladouceur, R., 
Leblanc, R. & Gervais N.J.  (2010). A randomized clinical trial of cognitive-
behavioral therapy and applied relaxation.  Behavior therapy, 41, 46-58.  
 
Dugas, M.J & Ladouceur, R. (2000) Treatment for GAD. Targeting intolerance of 
uncertainty in two types of worry. Behavior Modification, 24, 635-657.   
 
Dugas, M.J. & Robichaud, M. (2007) Cognitive-behavioral treatment for generalized 
anxiety disorder: From science to practice. New York, NY: Routledge. 

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Francis, C.Y., Morris, J. & Whorwell, P.J. (1997) The irritable bowel severity scoring 
system: a simple method of monitoring irritable bowel syndrome and its 
progress. Alimentary Pharmacology Therapeutics, 11, 395-402. 
Freeston, M.H., Tiplady, A., Mawn, L., Bottesi, G., & Thwaites, S. (2020, April, 14). 
Towards a model of uncertainty distress in the context of Coronavirus (Covid-
19) Preprint accessed 14/06/20 from  https://psyarxiv.com/v8q6m   
Freeston, M.H. (2020). Living Life with Uncertainty [PowerPoint Slides] 
Freeston, M.H. & Thwaites, R. (2014). Using self-monitoring with patients in routine 
clinical practice: A brief instruction guide for Cognitive-Behavioural 
Therapists.   
Hebert, E. A., & Dugas, M. J. (2019). Behavioral experiments for intolerance of 
uncertainty: challenging the unknown in the treatment of generalized anxiety 
disorder. Cognitive and Behavioral Practice, 26(2), 421-436. 
Hsee, C.K., & Ruan, B. (2016). The Pandora effect: The power and peril of curiosity. 
Psychological Science, 27, 659-666.  
Jacobson, N.S., & Truax, P. (1991). Clinical significance: a statistical approach to 
defining meaningful change in psychotherapy research. Journal of consulting 
and clinical psychology, 59 (1), 12-19. 
Jiang, X. & He, G. (2012). Effects of an uncertainty management intervention on 
uncertainty, anxiety, depression and quality of life of chronic obstructive 
pulmonary disease outpatients. Research in nursing and health, 35, 409-418. 
Kratochwill, T. R., Hitchcock, J., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, 
D. M & Shadish, W. R. (2010). Single-case designs technical documentation. 
Retrieved 
06/06/20 
from 
What 
Works 
Clearinghouse 
website 
: 
https://files.eric.ed.gov/fulltext/ED510743.pdf 
Kroenke, K., Spitzer, R.L. & Williams, J. (2001) The PHQ9; Validity of a brief 
depression severity measure. Journal of General Internal Medicine, 16 (9), 
573-647.   
Ladouceur, R., Dugas, M., Freeston, M., Leger, E., Gagnon, F., & Thibodeau, N. 
(2000). Efficacy of a cognitive-behavioural treatment for generalized anxiety 
disorder: Evaluation in a controlled clinical trial. Journal of Consulting and 
Clinical Psychology, 68, 957–964. 
McEvoy, P. M., Hyett, M. P., Shihata, S., Price, J. E., & Strachan, L. (2019). The 
impact of methodological and measurement factors on transdiagnostic 
associations with intolerance of uncertainty: A meta-analysis. Clinical 
psychology review, 73, 101778. 
McCormick, K. M. (2002). A concept analysis of uncertainty in illness. Journal of 
Nursing Scholarship, 34 (2), 127-131.    
 
Mishel, M.H. (1988). Uncertainty in Illness. The Journal of Nursing Scholarship, 20 
(4), 225-232. 

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Mishel, M.H. (1990) Reconceptualization of the uncertainty in illness theory. Image 
Journal of Nursing Scholarship, 22, 256-262. 
 
Mishel, M.H. & Epstein, D. (1997) Uncertainty in Illness Scales Manual. University 
of North Carolina, Chapel Hill. 
 
Mishel, M.H., Germino, B.B.,Gil, K.M., Belyea, M., LaNey, I.C., Stewart, J. & Clayton, 
M. (2005). Benefits from an uncertainty management intervention for African-
American and Caucasian older long-term breast cancer survivors. Psycho-
oncology, 14, 962-978.  
 
Mofrad, L., Tiplady, A., Payne, D. & Freeston, M. (2020) Making friends with 
uncertainty: experiences of developing a transdiagnostic group intervention 
targeting intolerance of uncertainty in IAPT. Feasibility, acceptability and 
implications. The Cognitive Behaviour Therapist, 13, 1-14.   
Molton, I.R., Koelmel, E., Curran, M., von Geldern, G., Ordway, A. & Alschuler, K.N. 
(2019). Pilot intervention to promote tolerance of uncertainty in early multiple 
sclerosis. Rehabilitation Psychology, 64 (3), 339-350.   
 
Morley, S. (2018). Single-case methods in clinical psychology. A practical guide. 
Oxon; Routledge.  
 
National Collaborating Centre for Mental Health (2018) The Improving Access to 
Psychological Therapies (IAPT) Pathway for People with Long-term Physical 
Health 
Conditions 
and 
Medically 
Unexplained 
Symptoms. 
Full 
implementation guidance. London: National Collaborating Centre for Mental 
Health.  
 
National Collaborating Centre for Mental Health (2020).The Improving Access to 
Psychological Therapies Manual. Retrieved from: 
https://www.england.nhs.uk/wp-content/uploads/2020/05/iapt-manual-v4.pdf 
on 22/02/21 
 
 
National Institute for Health and Clinical Excellence. (2007). Chronic fatigue 
syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and 
management. 
Clinical 
Guideline 
53. 
Retrieved 
from 
https://www.nice.org.uk/guidance/cg53 
National Institute for Health and Clinical Excellence. (2008). Irritable bowel 
syndrome in adults: diagnosis and management. Clinical guideline 61. 
Retrieved from https://www.nice.org.uk/guidance/cg61 
National Institute for Health and Clinical Excellence. (2016). Low back pain and 
sciatica in over 16s: assessment and management. Clinical Guideline 59.  
Retrieved from https://www.nice.org.uk/guidance/cg59 

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Naylor, C., Parsonage, M., McDaid, D., Knapp, M., Fossey, M. & Galea, A (2012) 
Long Term Conditions and Mental Health: The cost of co-mobidities. The 
King’s Fund and Centre for Mental Health.  
Parker, R.I., Vannest, K.J., Davis, J.L. & Sauber, S.B. (2011) Combining Nonoverlap 
and Trend for Single Case Research: Tau-U. Behavior Therapy, 42, 284-299.
Parr, J. R., Brice, S., Welsh, P., Ingham, B., Le Couteur, A., Evans, G., … & 
Rodgers, J. (2020). Treating anxiety in autistic adults: study protocol for the 
Personalised Anxiety Treatment–Autism (PAT-A©) pilot randomised 
controlled feasibility trial. Trials, 21(1), 1-14. 
Rosen, N.O., Knauper, B., Di Dio, P., Morrison, E., Tabing, R., Feldstain, A., 
Rosberger, Z. (2010). The impact of intolerance of uncertainty on anxiety after 
receiving an informational intervention about HPV: A randomised controlled 
study. Psychology & Health, 25, 651-668.     
Shevlin, M., Hyland, P., Ben-Ezra, M., Karatzias, T., Cloitre, M., Vallieres, F. … & 
Maercker, A. (2020). Measuring ICD-11 adjustment disorder: the 
development and initial validation of the Internal Adjustment Disorder 
Questionnaire. Acta Psychiatrica Scandinavica, 141 (3), 265-274.  
Spitzer, R.L., Kroenke, K., Williams, J.B., & Lőwe, B. (2006). A brief measure for 
assessing generalised anxiety disorder: the GAD-7. Archives of internal 
medicine, 166(10), 1092-1097. 
Taha, S., Matheson, K., Cronin, T., & Anisman, H. (2014) Intolerance of uncertainty, 
appraisals, coping and anxiety: The case of the 2009 H1N1 pandemic. British 
Journal of Health Psychology, 19, 592-605.  
Tan, G., Jensen, M.P., Thornby, J.I. & Shanti, B.F. (2004). Validation of the brief 
pain inventory for chronic non-malignant pain. The Journal of Pain, 5(2), 133-
137. 
 
Tiplady, A., Freeston, M., & Meares, K. (2017). The Development of a 
Transdiagnostic Intervention Targeting Intolerance of Uncertainty using 
Single Case Experimental Design. Unpublished doctoral thesis, Newcastle 
University, Newcastle Upon Tyne, UK.  
 
Zhang, Y., Kwekkeboom, K., Kim, K. S., Loring, S., & Wieben, A. M. (2020). 
Systematic Review and Meta-analysis of Psychosocial Uncertainty 
Management Interventions. Nursing research, 69(1), 3-12.
 
 
 

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8. APPENDICIES  
Appendix A- Measures 

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Appendix B- Overview of treatment phases including interventions and duration 
 
Phase
Overview of Intervention
Duration
Assessment session
Assessment and formulation 
of difficulties. Identification of 
treatment targets – 
establishment of daily diary 
measures.  
Completion of standardised 
questionnaires. 
1 session
Baseline (A)
Completion of daily diaries. 
 
2-4 weeks
Treatment Intervention (B)
Psychological therapy 
intervention to reduce 
uncertainty distress. 
Comprised of 4 modules 
1. Managing information
2. Building safety 
3. Addressing over-
estimation of threat 
4. Tolerating Uncertainty 
Each module will be between 
1-4 sessions based on 
individual need.     
Maximum 16 weeks
Monitoring (C )
No treatment
Continued completion of daily 
diaries 
Participant consolidates 
strategies learnt.  
4 weeks
Follow Up (D )
Relapse prevention session
 
Treatment evaluation 
questionnaire  
 
Completion of standardised 
(phase change) measures 
Single session 

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Appendix C- Treatment Fidelity Checklist 
Personalised Anxiety Treatment – Autism (PAT-A) 
Session Recording Form 
  
Participant ID:  
  
  
Therapist:    
Date:  
  
  
Session:  
Initial Treatment Plan:   
  
  
  
Current Treatment Plan:  
  
  
  
SUPERVISION: 
Has this case been discussed since the last session?                YES    NO 
Were changes to the treatment plan discussed?                    YES    NO 
What was the main conclusion from Supervision? 
Continue with current plan 
  
  
  
  
Adjust current plan 
  
Specify:  
  
  
  
  
Specify:  

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Change treatment plan 
  
  
  
Additional information/supervision notes:  
  
  
  
  
  
  
  
 
 
  
Session Recording Form Continued…  
  
Participant ID:  
  
Therapist:    
Date:  
  
Session:  
  
Research Information:  
Did the participant attend the session? 
YES    NO      
  
  
 
If No please detail the reasons for this if know 
  
  
  
  
  

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Did the participant consent to ongoing inclusion within the PAT-A trial? 
YES    NO      
  
  
 
If No please detail the reasons for this in the PAT-A site file and clinical 
notes 
  
  
  
  
  
  
How long did the session last? (approximate in minutes) 
  
………………   Minutes 
  
Please provide additional information if the session duration was longer/shorter than 
expected or did not last approximately 50-60 minutes:   
  
  
  
  
  
  
  
Have any adverse events occurred since the previous session? (Adverse events 
are defined here as all negative events that occur in parallel to treatment in relation to 
the patient) 
YES    NO      
  
 
If Yes please provide details using the Unwanted Events Checklist. If 
countermeasures are required please follow the Unwanted Events 
Standard Operating Procedure.  
  
  

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Has the participant received/started any therapies away from PAT-A since the 
previous session? (Therapies are defined here as formal psychological interventions, 
psychoeducational counselling, support groups or medication) 
YES    NO      
  
  
 
If Yes please provide a summary here 
  
  
  
  
  
  
  
  
 
 
  
Session Recording Form Continued…  
  
Participant ID:  
  
Therapist:           
Date:  
  
Session:  
General Structural Features of CBT  
                                      YES    NO 
  
If No, why not?  
Review/Check In 
  
  
  

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Agenda Setting 
  
  
  
Review Homework 
  
  
  
Feedback 
  
  
  
Homework Setting 
  
  
  
  
  
 
 
  
Assessment  
  
Participant ID:  
  
Therapist:    
Date:  
  
Session:  
Essential Elements: 
Not at 
all 
Touche
d on 
Sometime 
spent 
Main 
focus 
MINI diagnostic interview  

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Psychometrics  
What is IU (definition)  
Identifying uncertainty in everyday life 
Risk assessment  
Daily Diary development  
Exploring safety behaviours  
Interventions/strategies from another 
module: 
E.g. description of strategy/name of module 
1. 
  
 
2. 
  
 
3. 
  
 
Other Interventions/strategies utilised: 
  
  
  
 
 
  

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Socialisation to Intolerance of Uncertainty  
  
Participant ID:  
  
Therapist:    
Date:  
  
Session:  
Possible Elements: 
Not at 
all 
Touche
d on 
Sometime 
spent 
Main 
focus 
What is IU (definition, purpose)  
Evolutionary advantage of IU  
Identifying uncertainty in everyday life 
Recognising responses to uncertainty 
  
 
Recognising impact of uncertainty  
 
 
 Idea of uncertainty in the absence of threat 
Feeling unsafe in the absence of safety 
signals, threat vs uncertainty  
Physiological response to IU 
Reviewing the Uncertainty Cycle/formulation  
  
Identifying barriers & current coping 
strategies 
  
Cost Certainty Balance 
  
Positive outcomes from uncertain situations 
  

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Sitting with Uncertainty 
  
Risk monitoring   
Daily Diary monitoring   
Interventions/strategies from another 
module: 
E.g. description of strategy/name of module 
1. 
  
 
2. 
  
 
3. 
  
 
Other Interventions/strategies utilised: 
  
  
  
 
 
  
  
Low stakes exposure to Uncertainty Module 
  
Participant ID:  
Therapist:    

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Date:  
  
Session:  
Possible Elements: 
Not at 
all 
Touche
d on 
Sometime 
spent 
Main 
focus 
Developing non-threat based experiments 
with low likelihood of consequence of any 
value 
Reviewing previous low stakes experiment  
Cost-benefit analysis  
Daily diary monitoring 
Risk monitoring   
Interventions/strategies from another 
module: 
E.g. description of strategy/name of module 
1. 
  
 
2. 
  
 
3. 
  
 
Other Interventions/strategies utilised: 

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High stakes exposure to Uncertainty Module 
Participant ID:  
  
Therapist:    
Date:  
  
Session:  
Possible Elements: 
Not at 
all 
Touche
d on 
Sometime 
spent 
Main 
focus 
Engage in non-threat based experiments with 
higher potential consequence of value 
  
Daily Diary monitoring  
  
Risk monitoring  
Interventions/strategies from another 
module: 

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E.g. description of strategy/name of module 
1. 
  
 
2. 
  
 
Other Interventions/strategies utilised: 
  
  
  
  
 
 
  
Consolidation/end of treatment 
Participant ID:  
  
Therapist:    
Date:  
  
Session:  
Possible Elements: 
Not at 
all 
Touche
d on 
Sometime 
spent 
Main 
focus 
Discussed transferable learning of how this 
might apply to anxiety (threat based 
situations) 
Troubleshooting  

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Daily Diary monitoring  
  
Risk monitoring  
Interventions/strategies from another 
module: 
E.g. description of strategy/name of module 
1. 
  
 
2. 
  
 
Other Interventions/strategies utilised: 
  
  
  
 
 
  
Session Engagement 
  
Participant ID:  
  
Therapist:    
Date:  
  
Session:  
How verbally communicative was the participant during the therapy session 
(e.g. responding to the therapists questions)?  

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Disengaged 
(Participant rarely 
responds) 
Limited Response 
(Participant provides 
minimal information; e.g. 
Yes/No) 
Contributes 
(Participant provides 
information when 
required) 
Additional 
Contribution 
 (Participant provides 
additional information that 
is not requested) 
Is the participant able to remain attentive/on-task during the therapy session? 
Frequently Off-
task 
 (Struggles to remain 
on task throughout and 
difficult to  
re-engage) 
Occasionally On-task
(Participant remains on 
task for some exercises 
but difficult to re-engage)  
Frequently On-
task (Participant 
remains on task for 
most exercises. 
Attention can be 
regained easily)  
Remains On-task 
(Participant is highly 
engaged and attentive 
throughout the session) 
  
  
  
  
How often do the participant and therapist reach agreement?  
No Agreement 
(Participant/therapist 
rarely agree) 
Limited Agreement 
(Agreement is reached on 
occasions but with great  
difficulty) 
Some Agreement
(Agreement reached 
on some matters 
without difficulty) 
Frequent Agreement 
 (Participant and therapist 
agree on most matters 
discussed) 
  
Is there evidence that the participant understands the content discussed 
within the session?  
Does Not 
Understand  
(Unable to 
demonstrate any 
understanding even 
with scaffolding)  
Minimal 
Understanding  
(Understanding only 
demonstrated when 
significant prompting/ 
scaffolding given) 
Frequent 
Understanding 
 (Understanding 
demonstrated with 
minimal prompting/ 
scaffolding) 
  
High level of 
Understanding 
 (Participant is able to 
demonstrate high levels of 
understanding without 
prompting/scaffolding) 
  
 
  
  
  
  
Does the participant get stuck on particular content within the session?  
Frequently 
(For considerable 
periods/every time new 
material is introduced. 
Significantly impacts 
upon session) 
Sometimes 
(Participant becomes 
stuck on several 
occasions or for a 
significant period of time. 
Some impact on session) 
Rarely 
(Participant becomes 
stuck on one or two 
aspects. Does not 
significantly interfere 
with session) 
Not at all 
(Participant devotes 
appropriate time/effort on 
content throughout) 

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Is the participant able to process information in a timely manner?  
Rarely 
(Evidence of significant 
processing difficulties 
for the majority of the 
session) 
Sometimes 
 (Participant 
demonstrates processing 
difficulties on several 
occasions)    
Frequently 
(Participant able to 
process most 
information although 
possible difficulties 
observed) 
Timely Processing 
(No evidence of processing 
difficulties) 
  
  
  
  
Did the participant engage and complete the homework task set? 
Not 
Attempted 
Attempted but 
Abandoned 
Partially 
Completed 
Completed 
Extra Homework 
Completed 
  
Any other observation? (please describe)  
  
  
  
  
  
  
  
  
  
 
 
 
 
Unexpected Events (UE) Checklist  

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UE Class 
Present (description) 
Cont
ext  
Rela
tion  
Seve
rity 
Lack of clear 
treatment results 
 
 
 
 
Prolongation of 
treatment 
  
 
 
 
 
Non-compliance 
of the participant 
 
 
 
 
Emergence of 
new symptoms 
  
 
 
 
 
Deterioration of 
symptoms 
  
 
 
 
 
Negative 
wellbeing of the 
participant 
 
 
 
 
Strains in the 
Participant-
therapist 
relationship  
 
 
 
 
Very good 
Participant-
therapist 
relationship 
 
 
 
 
Strains in family 
relations 
  
 
 
 
 
Change in family 
relations 
  
 
 
 
 
Strains in work 
relations 
  
 
 
 
 
Changes in the 
work situation 
  
 
 
 
 

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Sick leave of the 
patient 
  
 
 
 
 
Problems in the 
extended social 
net 
 
 
 
 
Any changes in 
life circumstances 
 
 
 
 
Stigmatization 
  
 
 
 
 
  
Glossary of Ratings:  
Context 
Relation to 
Treatment 
Severity  
1. Assessment  
 
 
1. Unrelated 
1. Mild, without 
consequences 
2. Randomisation  
2. Probably 
unrelated 
  
 
2. Moderate, 
distressing  
3. Treatment 
3. Possibly 
related 
3. Severe, in need 
of 
countermeasures
* 
4. Treatment As Usual  
4. Probably 
related 
4. Very severe, 
lasting negative 
consequences 
5. Participant-therapist 
relationship  
5. Related 
5. Extremely 
severe, 
hospitalization 
required or life 
threatening  
6. End Of Treatment 
  
 
* If severity is rated as 3 or above please follow Unexpected Events 
Standard Operating Procedure  
  

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Checklist taken from: Linden, M. (2013). How to define, find and classify side effects in 
psychotherapy: from unwanted events to adverse treatment reactions. Clinical 
psychology & psychotherapy, 20(4), 286-296. 
 
 
 
 

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Appendix D- Alice Bentley’s (2020) Treatment Evaluation Form 
 Intolerance of Uncertainty Research Therapy Evaluation Form 
The following are some questions about your experience of the Intolerance of Uncertainty therapy. 
Please use this opportunity to be as honest as you can about your experience so we can use it to 
develop the therapy and help others in future. It may be that we discuss some of these questions 
further during our last session together.  
 
What was your main reason for volunteering to participate in the sessions?  
 
How would you like to describe your experiences of participating in the sessions?  
 
Did the explanation of Intolerance of Uncertainty as a common factor in a range of difficulties make 
sense to you? If not, what would have helped?  
 
What was the best thing about engaging in the sessions?  
 
What was the most difficult part of engaging in the sessions?  
 

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Is there anything that you think should have been done differently?  
 
How did you find the pace of the sessions? 
Too slow             Just right     Too Fast  
 
 
How did you find the content of the sessions? 
Not enough information     Just right        Too hard to understand 
 
 
How did you find the complexity of the sessions? 
Too simple for me             Just right         Too hard to understand 
 
 
Have the sessions helped you achieve the goals that you had for therapy? 
Not at all                           Partially            Completely 
 

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How would you rate the following aspects of the sessions in 
terms of how helpful they were? (Using the scale from 1 to 
5) 
1  
(Not at all 
helpful)  
2 
3 
4
5 
(Extremely  
Helpful) 
Having the chance to talk about my feelings 
 
 
Taking some time out to think about myself 
 
 
 
 
Completing tasks outside of the session 
 
 
 
 
Talking to my family/friends about things we discussed in 
sessions 
 
 
 
 
Using daily diaries to track my feelings, thoughts and 
behaviours 
 
 
Talking about how avoiding uncertainty may have played a 
role in the development of my difficulties 
 
 
Using maps/diagrams to understand the role that 
uncertainty may have played in the development of my 
difficulties 
 
 
Talking about how avoiding uncertainty may have played a 
role in keeping my difficulties going (maintenance) 
 
 
Using maps/diagrams to understand the role that 
uncertainty may have played in keeping my difficulties going 
 
 
Understanding the types of things I do to avoid uncertainty 
in my everyday life (e.g. planning, routines, reading reviews) 
 
 
Understanding the types of things that I do to avoid 
uncertainty in situations that cause me anxiety (e.g. checking 
behaviours, googling symptoms) 
 
 
Changing some of the things I do in response to uncertainty 
in everyday life 
 
 
Changing some of the things I do to avoid uncertainty in 
situations that cause me anxiety 
 
 
Reflecting on the impact of doing things differently in my 
everyday life 
 
 
Reflecting on the impact of doing things differently in 
situations that cause me anxiety 
 
 

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Appendix E – Ethics Grid 
 
NEWCASTLE UNIVERSITY 
DOCTORATE IN CLINICAL PSYCHOLOGY 
Research Course: Ethical Issues Reflection Grid for Research Projects 
Trainee name: 
Sarah Kay
Date:
15/06/2020
Project title: Piloting an intervention using single case design to reduce uncertainty distress in those with long term health conditions and associated 
anxiety.   
Where will ethical approval be sought for this project? Ethical approval will be sought from the National Research Ethics Service.
 
 
Not 
applicable 
Issue is 
considered 
to be of no 
or minimal 
concern 
Issue is 
considered 
to raise 
moderate 
concerns 
Issue is 
considered 
raise high 
levels of 
concern 
For issues raising moderate or high levels of concern, indicate how will they 
be managed 
Note: It would be good practice to explain why a specific issue is of no or 
minimal concern, rather than simply tick the box. 
 
Issues arising from the study design 
Specific issues 
in obtaining 
informed 
consent (age, 
capacity, etc.) 
☐ 
 
☒ 
☐ 
Participants will be given clear written information about the aims of the study and 
what is required in the Participant Information Sheet (PIS) prior to the beginning of 
the study. Participants will be given at least 48 hours to consider participation. 
Written consent forms will be signed and participants will be given the opportunity 
to ask questions to clarify any details. For those wishing to have remote therapy , 
electronic Consent forms will be signed via Qualrics, survey software. Participation 
will be on a voluntary basis and the researcher will check the participants 
understanding of the requirements of the study to ensure they are making an 
informed choice as whether they wish to be part of the study.    

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Not 
applicable 
Issue is 
considered 
to be of no 
or minimal 
concern 
Issue is 
considered 
to raise 
moderate 
concerns 
Issue is 
considered 
raise high 
levels of 
concern 
For issues raising moderate or high levels of concern, indicate how will they 
be managed 
Note: It would be good practice to explain why a specific issue is of no or 
minimal concern, rather than simply tick the box. 
 
Written 
consent will 
not be 
obtained 
☒ 
 
☐ 
☐ 
Written consent will be obtained through a consent form. For those wishing to have 
remote treatment intervention this will be done via an electronic version of the 
consent form accessed through a link to Qualtrics survey software. 
Consent will 
be obtained 
online 
☒ 
☐ 
☐ 
☐ 
Consent will be obtained in person or via link accessed through a smart phone to 
electronic form via Qualtrics.  
Impact of 
excluding 
participants 
from the 
research 
☐ 
☒ 
☐ 
☐ 
As this is a feasibility treatment study the inclusion and exclusion criteria have been 
tightly defined. No potential participant will be disadvantaged by being excluded 
from the study as they will remain on the waiting list to access treatment as usual 
from the health psychology department.  
Collection of 
intrusive or 
sensitive data 
raising 
specific issues 
of storage, 
etc. 
☐ 
 
☐ 
☐ 
Clinical data will be recorded on the host NHS trust’s electronic record keeping 
system which is password protected and recorded on an encrypted system in line 
with NHS information governance policy. Any additional ‘research’ data will be 
recorded on the University’s secure server but will not include any personal 
identifiable information. Participants will complete daily diaries via ‘Qualtrics’ which 
will be accessed via a password and not include any identifiable information.   
Deception 
☒ 
 
☐ 
☐ 
The aims of the study will be transparent to the participant.
Intended 
provision of  
advice 
☐ 
 
☒ 
☐ 
If the participant asks for any advice outside of the treatment protocol they will be 
signposted back to their physical health team for this.   

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Not 
applicable 
Issue is 
considered 
to be of no 
or minimal 
concern 
Issue is 
considered 
to raise 
moderate 
concerns 
Issue is 
considered 
raise high 
levels of 
concern 
For issues raising moderate or high levels of concern, indicate how will they 
be managed 
Note: It would be good practice to explain why a specific issue is of no or 
minimal concern, rather than simply tick the box. 
 
Incentives 
☐ 
☐ 
☒ 
☐ 
As a reimbursement for time spent completing the daily diaries and other outcome 
measures the participants will be offered shopping vouchers. The amount will be 
determined using a wage payment model (Dikert & Grady 1999). All costs covered 
by Newcastle University school of Psychology 
Debriefing 
☐ 
☒ 
☐ 
☐ 
Participants will be offered a debriefing session however this is not likely to raise 
ethical issues as the participants will be aware of the purpose of the research from 
the beginning. They will be given the opportunity to provide feedback on the 
treatment intervention. 
Use of 
gatekeepers 
☐ 
☐ 
☒ 
☐ 
Gatekeepers within the host NHS Trust will facilitate access to potentially suitable 
participants. They will be briefed as to the aims of the study and inclusion/exclusion 
criteria to aid them in doing so.   
Data 
collected 
outside EU/ 
EEA 
☒ 
☐ 
☐ 
☐ 
Data is only to be collected within the EU
Data 
exported 
outside EU/ 
EEA 
☒ 
 
☐ 
☐ 
Data will not be exported outside of the EU
Online 
collection of 
data 
☐ 
☐ 
☒ 
☐ 
Some data (daily diaries) will be collected through Qualtrics. This will be accessed by 
the participant using a unique password known only to them and then retrieved by 
the researcher.  
Use of social 
media for 
data 
collection 
☒ 
☐ 
☐ 
☐ 
Data will not be collected via Social Media. 

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Not 
applicable 
Issue is 
considered 
to be of no 
or minimal 
concern 
Issue is 
considered 
to raise 
moderate 
concerns 
Issue is 
considered 
raise high 
levels of 
concern 
For issues raising moderate or high levels of concern, indicate how will they 
be managed 
Note: It would be good practice to explain why a specific issue is of no or 
minimal concern, rather than simply tick the box. 
 
Burden to 
participants 
☐ 
☐ 
☒ 
☐ 
Participants will be advised that will all psychological therapies there is a potential 
for distress when discussing their difficulties however this is no different from the 
treatment they will be on the waiting list to receive. The main burden is time taken 
to complete daily diaries and other outcome measures.  Participants will be 
informed of the likely time commitment required within the Participant Information 
Sheet (PIS) and will be re compensated for this time using a Wage Payment Model.  
Use of 
personal 
material in 
dissemination 
of research 
(e.g. 
quotations) 
☒ 
 
☐ 
☐ 
Personal quotes will not be included in the dissemination of the research.
Descriptions 
of specific 
participants 
in 
dissemination 
of research 
☐ 
 
☒ 
☐ 
Participants will be referred to by pseudonyms. Care will be taken that combination 
of demographics (age, gender, and ethnicity) will not make a person identifiable. 
Some background information will be included to provide context of the 
participants but non-essential information will be omitted or changed to maintain 
anonymity.  
Other: 
☐ 
☐ 
☒ 
☐ 
Please specify: Right to Withdrawn
As in any other psychological therapy participants will be given the right to 
withdraw during the study without having to provide an explanation. They can 
return to their prior place on the waiting list to access treatment as usual. If 
participants withdraw they will be asked for permission to still use their data 
however this is entirely optional and they can decline.   
 
 

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Issue 
Issue is 
considered 
to be of no 
or minimal 
concern 
Issue is 
considered 
to raise 
moderate 
concerns 
Issue is 
considered 
to raise 
high levels 
of concern 
Likelihood 
of the issue 
arising 
Please provide brief explanatory comment as necessary (issues raising 
moderate/high levels of concern and/or with medium/high likelihood of arising 
require further justification).  Table will expand as you write into each box. 
Note: It would be good practice to explain why a specific issue is of no or 
minimal concern, rather than simply tick the box.
Issues arising in the conduct of the study 
Stress to 
participants 
☐ 
☒ 
☐ 
V low
Low 
Mediu
m 
High 
☐
☐
☒
☐
As with any psychological therapy intervention there is the potential for it to be 
distressing to the participant when discussing their problems. However this is no 
greater than the potential for this to happen in treatment they would receive as 
usual. Participants will be advised of this in the participant information sheet. 
Harm to 
participants 
☐ 
☒ 
☐ 
V low
Low 
Mediu
m 
High 
☐
☒
☐
☐
As with any psychological therapy there is a potential for mental health to 
deteriorate during treatment. If this were to happen supervision would be sought 
and options would be discussed explicitly with the participant as to whether they 
wanted to be referred for additional support and treatment.  
Disclosure by 
participants  of 
information 
that my need 
acting on 
☐ 
☒ 
☐ 
V low
Low 
Mediu
m 
High 
☐
☐
☒
☐
During the research study a participant may disclose something that needs acting 
upon such as risks to self and/or others. Participants will be explicitly advised at 
the start of the treatment intervention that if this were to occur that 
confidentiality would be broken. If it is safe to do so the participant will be 
advised that the information will be shared and with whom. The researcher will 
have access to contact details for participants GP, local Crisis Team, local social 
care duty teams. Support and advice will be sought from the clinical supervisor 
attached to the research project.   
Discovery of 
information 
that my need 
acting on 
☐ 
☒ 
☐ 
V low
Low 
Mediu
m 
High 
☐
☐
☒
☐
During the research study discovery of information that needs acting on may be 
made. Participants will be explicitly advised at the start of the treatment 
intervention that if this were to occur that confidentiality would be broken. If it is 
safe to do so the participant will be advised that the information will be shared 
and with whom. The researcher will have access to contact details for participants 
GP, local Crisis Team, local social care duty teams. Support and advice will be 
sought from the clinical supervisor attached to the research project.   

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Issue 
Issue is 
considered 
to be of no 
or minimal 
concern 
Issue is 
considered 
to raise 
moderate 
concerns 
Issue is 
considered 
to raise 
high levels 
of concern 
Likelihood 
of the issue 
arising 
Please provide brief explanatory comment as necessary (issues raising 
moderate/high levels of concern and/or with medium/high likelihood of arising 
require further justification).  Table will expand as you write into each box. 
Note: It would be good practice to explain why a specific issue is of no or 
minimal concern, rather than simply tick the box.
Participants 
seeking advice 
☐ 
☒ 
☐ 
V low
Low 
Mediu
m 
High 
☐
☐
☒
☐
If a participant seeks advice outside of the treatment protocol the participant will 
be signposted to the relevant person involved with their care to answer that.  
Other: 
☐ 
☐ 
☐ 
V low
Low 
Mediu
m 
High 
☐
☐
☐
☐
Please specify:
 
 
Have people 
with lived 
experience of 
the issue been 
involved in: 
No, not 
appropriate 
This would 
have been 
desirable  
Yes 
If yes, to 
what 
extent 
Please provide brief explanatory comment as to your decision to consult or not, and if 
so, in which aspects were people with lived experience involved.  Table will expand as 
you write into each box. 
Participation of people with lived experience in the research process 
Planning 
☐ 
☐ 
☒ 
A little
On key 
issues 
A lot 
☒
☐
 
☐
Please specify:
Feedback from participants from prior programmatic research into intolerance of 
uncertainty interventions will be taken into account when designing this treatment 
protocol   

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Have people 
with lived 
experience of 
the issue been 
involved in: 
No, not 
appropriate 
This would 
have been 
desirable  
Yes 
If yes, to 
what 
extent 
Please provide brief explanatory comment as to your decision to consult or not, and if 
so, in which aspects were people with lived experience involved.  Table will expand as 
you write into each box. 
Design/review  
☒ 
☐ 
☒ 
A little
On key 
issues 
A lot 
☐
☐
 
☐
Please specify:
 
Oversight  
☒ 
☐ 
☐ 
A little
On key 
issues 
A lot 
☐
☐
 
☐
Please specify:
Analysis/ 
write up  
☒ 
☐ 
☐ 
A little
On key 
issues 
A lot 
☐
☐
 
☐
Please specify:
Other  
☐ 
☐ 
☒ 
A little
On key 
issues 
A lot 
☐
☐
 
☒
Please specify:
The treatment protocol is co-constructed with each participant and they play an active 
part in their treatment.   
 
 
Data Management 
Not yet  
Yes 
What are/will be key data management issues (e.g. pseudonymization/anonymization of data, 
keeping in contact with participants, sharing of data, transfer of data, etc.)?  How will  this be 
managed 
Data management 
Have you developed a data 
management plan 
☒ 
☐ 
Please specify:

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Data Management 
Not yet  
Yes 
What are/will be key data management issues (e.g. pseudonymization/anonymization of data, 
keeping in contact with participants, sharing of data, transfer of data, etc.)?  How will  this be 
managed 
Does it conform to GDPR 
2018?  
☐ 
☒ 
Please specify: Personal data will be held within the host NHS Trust and therefore will comply with NHS 
information governance which includes GDPR. No personal data will be on the University server- scores 
will be held under Pseudonyms.  
Mark Freeston 2020 
 
Appendix F –Diversity Grid 
 
NEWCASTLE UNIVERSITY DOCTORATE IN CLINICAL PSYCHOLOGY 
Research Course: Social Diversity Reflection Grid for Research Projects 
Dimension  
(from Burnham, 1993) 
1. Focus of 
study to 
some 
degree 
2. Part of 
selection, or 
measured/ 
assessed, or 
controlled 
for 
3. 
Considered 
unlikely to 
interact 
with other 
variables 
and so not 
measured 
4. 
Considered  
when 
selecting or 
designing 
measures or 
developing 
guidelines, 
instructions 
or  
procedures 
 
 
 
 
 
Does this 
dimension 
raise potential 
ethical issues 
in your 
proposed 
study?
Trainee 
name: 
Sarah Kay 
Date:
15/06/2020
Project title:
Please provide brief explanatory comment as necessary.  Table will expand 
as you write into each box. 
1. Gender 
☐ 
☒ 
☒ 
☐ 
☐ 
Gender is not selected but will be included in descriptors of participants to 
provide contextual information. 
2. Geography 
☐ 
☐ 
☐ 
☒ 
☐ 
Geographical location considered – participants will be made aware of where 
the study (treatment intervention) is to take place. As the participants will be 
recruited from a regional hospital and no reimbursement for travel costs will 
be available this may impact upon who chooses to participate.  
3. Race 
☐ 
☒ 
☐ 
☐ 
☐ 
Not selected for but will be included in descriptors of participants to provide 
contextual information. 

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4. Religion 
☐ 
☐ 
☒ 
☐ 
☐ 
Not seen as to interact with other variables in this study and therefore not 
asked.  
5. Age 
☐ 
☒ 
☐ 
☐ 
☐ 
Selection criteria is over 18. Age will be reported to provide contextual 
information but not selected for.  
6. Ability 
☐ 
☒ 
☐ 
☒ 
☐ 
Participants will be selected with a reading age of 15 and basic GCSE level 
English. This will ensure that they will be able to understand the main 
theoretical concepts of the study (intolerance of uncertainty) and utilise 
written materials provided. This is a feasibility study which means that any 
additional adaptations of concepts and materials are beyond the remit of this 
study. 
7. Appearance 
☐ 
☐ 
☒ 
☐ 
☐ 
Not considered to interact with other variables in this study.
8. Class 
☐ 
☐ 
☐ 
☒ 
☐ 
Not selected for or used as a descriptor. Considered in terms of its influencing 
factor on who may access health care provisions and psychological therapy 
provisions.   
9. Culture 
☐ 
☒ 
☐ 
☒ 
☐ 
Not selected for but will be included in descriptors of participants to provide 
contextual information. 
May come into treatment interventions particularly those which are co-
constructed. This will only be the case if the participant brings it into the 
treatment interventions.   
10. Ethnicity 
☐ 
☒ 
☐ 
☒ 
☐ 
Not selected for but will be included in descriptors of participants to provide 
contextual information. 
May come into treatment interventions particularly those which are co-
constructed. This will only be the case if the participant brings it into the 
treatment interventions.   
11. Education 
☐ 
☒ 
☐ 
☒ 
☐ 
Participants will be selected with a reading age of 15 and basic GCSE level 
English. This will ensure that they will be able to understand the main 
theoretical concepts of the study (intolerance of uncertainty) and utilise 
written materials provided. This is a feasibility study which means that any 
additional adaptations of concepts and materials are beyond the remit of this 
study.    

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12. Employment 
☐ 
☐ 
☐ 
☒ 
☐ 
Participants’ employment status may impact on their ability to attend regular 
treatment intervention sessions within the times the researchers are able to 
commit to.  
13. Sexuality   
☐ 
☐ 
☒ 
☐ 
☐ 
Not considered to interact with other variables and therefore will not be 
asked. 
14. Sexual 
orientation 
☐ 
☐ 
☒ 
☐ 
☐ 
Not considered to interact with other variables and therefore will not be 
asked.  
15. Spirituality 
☐ 
☐ 
☒ 
☐ 
☐ 
Not considered to interact with other variables and therefore will not be 
asked. 
Other 1 
☒ 
☐ 
☐ 
☒ 
☐ 
HEALTH:
Participants will be selected on the basis of having a long term health 
condition as this is the population of interest for the study.  
Other 2 
☐ 
☐ 
☐ 
☐ 
☐ 
Other 3 
☐ 
☐ 
☐ 
☐ 
☐ 
Mark Freeston, May, 2018.   
References:  
Burnham, J. (1993). Systemic supervision. The evolution of reflexivity in the context of the supervisory relationship. Human Systems, 4, 349-381.   
Burnham, J. (2013). Developments in Social GGRRAAACCEEESSS: visible-invisible, voiced-unvoiced. In I. Krause (Ed.), Cultural Reflexivity. London: Karnac. 
 
 
 
 

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Appendix G – Participant Reimbursement 
 
The national minimum wage in the UK as of April 2020 is £8.20 per hour for those 
aged 21-24 and £8.72 for those over 25. (Obtained from https://www.gov.uk/national-
minimum-wage-rates) 
A payment of £9 per hour will be given to research participants pro rata for the 
completion of daily diaries. It is estimated that the daily diaries will take 5 minutes 
each day and therefore it is estimated that participants will spend 35 minutes 
completing diaries each week.     
Baselines will vary between participants and also the number of interventions will 
also vary depending on clinical need of each participant. Below is the calculation for 
the maximum amount of reimbursement based on baseline of 4 weeks and 
completion of all 16 sessions in the treatment phase.   
 
Phase  
Time (minutes) spent 
completing Diaries 
Total Payment 
Baseline (4 weeks) 
140 
£21 
Intervention (16 weeks)  
560 
£84 
Monitoring (4 weeks) 
140 
£21 
Follow up 
35 
£5.25 
 
 
£131.25 
 
 
 
 

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Appendix H- Costing Grid     

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Trainee Name:
Sarah Kay
Cohort: 2019-2022
EXPENSE TYPE
DESCRIPTION
COST
Travel
0
Photocopying
£0
Materials
£0
Participants
Participant reimbursment based on wage payment model - maximum £131.25 per participant x 6 £788
Postage
Other
Text message reminder service for daily diaries (Textlocal- 1200 text messages required)
£70.56
Total University Costs:
£858.06
Date
EMPLOYER COSTS
Note, in most cases employer will cover travel costs.
EXPENSE TYPE
DESCRIPTION
COST
Travel
Photocopying
Materials
Participants
Postage
Other
Total Employer Costs:
£0.00
Date
OTHER ORGANISATIONNHS Host Trust (Newcastle Hopsital Trust)
EXPENSE TYPE
DESCRIPTION
COST
Travel
Photocopying
Materials
Participants
Postage
Other
Total Other Costs:
£0.00
Approved (Name)
Signature
Date
Costs of under £200 to be paid by either by the University or Employer will normally be approved.  If the total to be paid by either the University or the Employer exceeds 
£200, a detailed justification signed by the trainee[s] and supervisor must be attached. In both cases the Panel Chair will indicate whether the costs appear justified. The 
final decision is made at a cohort level given the budget envelope is for the entire cohort, this will be reviewed by the Research Director in consultation with the School 
Administrator.
15/06/2020
 Participant costs MUST be approved by the School Administrator prior to data collection commencing.  
You must provide as much detail as possible on number of participants, type of participation and level of remuneration requested. Participation in research will normally be 
rewarded with Amazon e-vouchers either in the form of a token of appreciation to all participants (normally £5) or entry to a prize draw ( voucher of £20-£25 per XXX 
participants).
Please note that any requests for participant costs outside of normal boundaries must be provided with a full justification and confirmation from supervisor.

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