Acceptance and Commitment Therapy for Older Adults Experiencing Psychological Distress: A Hermeneutic Single Case Efficacy Design (HSCED) Series
Phase: NA
Conditions: Psychological Distress, Anxiety, Depression
Sponsor: University of Lincoln

 
Page 1 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL 
Acceptance and Commitment Therapy for older adults 
experiencing psychological distress: A hermeneutic single case 
efficacy design (HSCED) series 
ACT for older adults: a HSCED series  
ACT OA: HSCED                
 
Protocol Final Version 1.5 
Date 07.04.2020 
 
 
IRAS Project ID 
274334 
Registration ID 
NCT04280445 
Sponsor  
University of Lincoln 
Sponsor ID 
191201 
Funder 
Research as part of Doctoral Thesis in Clinical Psychology, Trent 
programme. 
 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
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(s). 
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. 
 
Chief Investigator:  
Signature: ............................................................................. 
Date: ....../....../...... 
Name: Dr Nima Golijani-Moghaddam 
 
 
 
 
 
 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
STUDY/TRIAL CONTACTS 
Chief Investigator 
 
Sponsor  
 
Contact details: 
 
Collaborators/Co-
Investigators/Protocol 
Contributors 
 
Student researcher/therapist
 
FUNDER DETAILS 
FUNDER(S) 
 
FINANCIAL AND NON 
FINANCIALSUPPORT GIVEN 
Trent DClinPsy 
 
£500 research budget. 
 
Research supervisors/supervision. 
 
Relevant teaching/training. 
Nottingham Healthcare NHS Foundation 
Trust (contact details above). 
 
Access to participants. 
 
Use of clinical premises. 
 
Clinical supervision. 
 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
STUDY SUMMARY 
Study Title 
Acceptance and Commitment Therapy for older adults: A 
hermeneutic single case efficacy design (HSCED) series 
 
Study Design 
Hermeneutic Single Case Efficacy Design (HSCED) 
Intervention 
Acceptance and Commitment Therapy 
Study Participants 
Older Adults (65 years+) 
Eligibility Criteria 
HADS Anxiety or Depression score ≥8; MoCA score ≥22-24 
(criterion dependant on age & education history); active 
referral to Rushcliffe Mental Health Service for Older People; 
have capacity to consent to 1:1 therapy; be able to travel to 
service (alone or with support). 
Planned Sample Size 
Up to four 
Study Duration 
Up to 20 months 
Objectives 
Primary: Efficacy of ACT with older adults experiencing 
psychological distress. 
Secondary: Identify change processes of ACT with older 
adults, with emphasis on the impact of delivering ACT by 
telephone/videocall (following SARS-CoV-2 social distancing 
measures). 
Outcome Measures 
Primary: Quality of life (OPQOL-brief). 
Secondary: Cognitive functioning (MoCA); levels of 
anxiety/depression (HADS); Client’s goals (PQ); quality of 
life/general outcomes (ORS); therapeutic alliance (SRS); 
client’s views on the therapy session (HAT); psychological 
flexibility (CompACT-8); client’s view on change (Change 
Interview); fidelity of treatment (ACT-FM). 
Exploratory: beneficial adaptations to ACT for older adults. 
Impact of telephone/videocall therapy on outcomes. 
Data Analysis  
Reliable Change Index; adjudication panel; Framework 
Analysis; correlations; visual analysis. 
 
KEY WORDS 
Older Adults 
Acceptance and Commitment Therapy  
Quality of Life 
Hermeneutic Single Case Efficacy Design 

 
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Change processes 
Non-specific factors 
Table of Contents 
 
STUDY/TRIAL CONTACTS .................................................................................................. 3 
FUNDER DETAILS ............................................................................................................... 3 
STUDY SUMMARY .............................................................................................................. 4 
KEY WORDS ........................................................................................................................ 4 
LIST OF ABBREVIATIONS ................................................................................................... 7 
STUDY MANAGEMENT ....................................................................................................... 8 
ROLE OF STUDY SPONSOR AND FUNDER ............................................................... 8 
STUDY BACKGROUND and RATIONALE ........................................................................... 8 
STUDY OBJECTIVES AND PURPOSE .............................................................................. 10 
PURPOSE ....................................................................................................................... 10 
PRIMARY OBJECTIVE ................................................................................................... 10 
SECONDARY OBJECTIVE(S) ........................................................................................ 10 
OUTCOME MEASURES ..................................................................................................... 10 
PRIMARY OUTCOME MEASURE .................................................................................. 10 
SECONDARY OUTCOMES ............................................................................................ 10 
EXPLORATORY OUTCOMES ........................................................................................ 11 
TABLE OF OUTCOMES.................................................................................................. 11 
STUDY DESIGN ................................................................................................................. 12 
DATA ANALYSIS ............................................................................................................ 13 
STUDY SETTING ............................................................................................................ 16 
SELECTION OF PARTICIPANTS ....................................................................................... 16 
ELIGIBILITY CRITERIA ................................................................................................... 16 
Inclusion Criteria .......................................................................................................... 16 
Exclusion Criteria ......................................................................................................... 16 
Sampling and size of sample ....................................................................................... 17 
Sampling technique ..................................................................................................... 17 
RECRUITMENT .............................................................................................................. 17 
Participant Payment ..................................................................................................... 17 
CONSENT ....................................................................................................................... 17 
STUDY PROCEDURES/REGIMEN .................................................................................... 19 
STUDY FLOWCHART .................................................................................................... 19 
RANDOMISATION AND BLINDING ............................................................................... 20 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
STUDY REGIMEN........................................................................................................... 20 
SCHEDULE OF PROCEDURES ..................................................................................... 23 
WITHDRAWAL ................................................................................................................ 24 
ETHICAL AND REGULATORY CONSIDERATIONS .......................................................... 24 
ASSESSMENT AND MANAGEMENT OF RISK .............................................................. 24 
ADVERSE EVENTS ........................................................................................................ 25 
Participant reporting of adverse events............................................................................ 26 
Participant removal from the study due to adverse events ............................................... 26 
ETHICS REVIEW AND COMPLIANCE ........................................................................... 26 
PEER REVIEW ............................................................................................................... 27 
PUBLIC & PATIENT INVOLVEMENT .......................................................................... 27 
PROTOCOL COMPLIANCE ............................................................................................ 28 
DATA PROTECTION AND PATIENT CONFIDENTIALITY ................................................. 28 
INDEMNITY ........................................................................................................................ 28 
ACCESS TO THE FINAL DATASET ............................................................................... 28 
DISSEMINATION POLICY .................................................................................................. 29 
REFERENCES ................................................................................................................... 30 
 
 
 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
ACT 
Acceptance and Commitment Therapy 
CF 
Consent Form 
CI 
Chief Investigator 
CRF 
Case Report Form 
FS 
Field Research Supervisor 
GCP 
Good Clinical Practice 
HRA 
Health Research Authority 
ISF 
Investigator Site File (This forms part of the TMF) 
ISRCTN 
International Standard Randomised Controlled Trials Number 
LIH 
Lincoln Institute for Health 
MHSOP 
Mental Health Service for Older People 
NHS R&D 
National Health Service Research & Development   
OA 
Older Adult 
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
PRS 
Primary Research Supervisor 
QP1 
Questionnaire Pack 1 
RCT 
Randomised Control Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure  
SRS 
Secondary Research Supervisor 
TMF 
Trial Master File 
TMG 
Trial Management Group 
UoL 
University of Lincoln 
 
 

 
Page 8 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
STUDY MANAGEMENT  
ROLE OF STUDY SPONSOR AND FUNDER 
The sponsor of the study is the University of Lincoln (UoL). 
The Chief Investigator (CI) has overall responsibility for the study and shall oversee all study 
management. The CI is Dr Golijani-Moghaddam, who is also Secondary Research 
Supervisor 
to 
Jonathan 
O’Keeffe 
(Trainee 
Clinical 
Psychologist) 
the 
student 
researcher/therapist for this study. As the main researcher, the student researcher/therapist 
will complete the majority of work required for the study design, conduct, data analysis and 
interpretation, manuscript writing, and dissemination of results.  
The student researcher/therapist will be supported by the research team of Primary 
Research Supervisor (Dr De Boos), Secondary Research Supervisor (Dr Golijani-
Moghaddam) and Field Research Supervisor (Dr Burrell). Their involvement will vary 
depending on their role and expertise. 
STUDY BACKGROUND and RATIONALE 
In older adults (OAs), anxiety and depression are associated with increased levels of 
disability (Brenes et al., 2008). There are also high co-morbidity rates for physical illness in 
the population with around 30% of 60-64-year olds having more than one diagnosed 
condition, rising to around 75% by age 85 (Age UK, 2017). Interestingly, poor mental health 
in older age has a stronger association with lower life satisfaction than poor physical health 
(Puvill, Lindenberg, De Craen, Slaets & Westendorp, 2016). With the percentage of the 
population aged over 65 anticipated to double by 2050 (World Health Organisation, 2017), it 
is increasingly important that mental health treatment for OA are achieving maximum 
outcomes. First line treatments for OA mental health are usually pharmacological in nature 
(Andreescu & Reynolds, 2011), with adults aged 75+ ten times more likely to receive 
medication than psychological therapy (McManus, Bebbington, Jenkins & Brugha, 2016). 
This is contrary to current clinical guidelines for adults, where a stepped-care model 
recommends psychological interventions as primary treatment for mild to moderate 
anxiety/depression (National Institute for Health and Care Excellence [NICE], 2018, 2019). 
This high rate of pharmacological interventions is also problematic due to increased side 
effects, as well as OAs being underrepresentation in clinical trials (Fialová et al., 2019; 
Konrat et al., 2012). As age increases, rates for common mental health problems are lower 
and less severe (McManus et al., 2016), suggesting that standard treatment is out of sync 
with both clinical recommendations and client preferences. 
There is evidence that OAs prefer psychological interventions over medication (Gum et al., 
2006), however, older generations are less likely to talk about their feelings and vocalise a 
need for emotional support (Knight & Poon, 2008). Further barriers include that care for OAs 
focuses more on the practical and physical health aspects, rather than the emotional and 
psychological (McCabe, Davison, Mellor & George, 2009). If the OA population are framed 
through a medical model, perhaps there is a propensity to treat based in a medical manner 
(i.e. psychiatric and pharmacological). Hindering change in clinical practice is a relatively 
small evidence base of psychological treatments for OAs; due in part to the mismatch 
between strict randomised controlled trial (RCT) criteria and high co-morbidity rates in OAs 
(Gatz, 2006). 
Following the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 
the UK in February 2020, social distancing measures have advised for all non-essential 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
contact between individuals to be ceased (Public Health England, 2020). Subsequently, the 
study will move to delivering the intervention by telephone or by video calling. Although there 
are some initial studies into the use of telephone-delivered ACT for smoking cessation 
(Bricker et al., 2010; Bricker et al., 2014), as well as a review of the impact of telephone 
support on self-directed ACT (French, Golijani-Moghaddam, & Schröder, 2017) this study 
will be the first to investigate the effectiveness of a phone/videocall therapist-delivered ACT 
intervention for older adults. 
For younger/working age adults, cognitive-behaviour therapy (CBT) is the most evidence-
based psychological treatment for mental health conditions (Hofmann, Asnaani, Vonk, 
Sawyer, & Fang, 2012). A recent meta-analysis demonstrated large effect sizes for CBT with 
working age adults, however, for OAs the effect size reduced to a moderate level (Kishita & 
Laidlaw, 2017). CBT works be emphasising the link between thoughts and feelings, and 
uses cognitive restructuring to facilitate improvement in psychological symptoms. When CBT 
was compared to Acceptance and Commitment Therapy (ACT; Hayes, Strosahl & Wilson, 
1999) with individuals experiencing chronic pain, age was shown to moderate response to 
treatment, with older adults responding better to ACT (Wetherell et al., 2016). 
ACT theorises that better quality of life can be achieved by developing psychological 
flexibility, an adaptive situational response to the competing demands of life (Kashdan & 
Rottenberg, 2011). Rather than altering the content of thoughts, the therapist guides a client 
through several interconnected processes (e.g. Acceptance, Values, or Committed Action). 
The goal is to develop a different relationship with thoughts and distress, rather than to 
eliminate these. Butler & Ciarrochi (2007) have demonstrated that older adults with higher 
psychological acceptance exhibited higher quality of life in areas of health, safety, 
community participation and emotional well-being. 
Meta-analyses have demonstrated the efficacy of ACT compared to placebo, however, the 
way in which ACT is effective is less understood (Öst, 2014). Therefore, it is not only crucial 
to provide further evidence of whether ACT is an effective intervention for older adults, is 
important to understand the processes that make it effective. Randomised controlled trails 
(RCTs) are often used as the ‘gold standard’ in establishing the efficacy of a 
psychotherapeutic model (Hariton & Locascio, 2018). However, in order to demonstrate 
causality, RCTs require the application of strict criteria to the study variables (e.g. participant 
diagnoses, age range) or the removal of extraneous factors (e.g. preventing participants 
changing medications during the study). This has led to criticisms as to whether RCTs are 
wholly appropriate when investigating the complexities of how and why a psychotherapy is 
or is not effective (Elliott, 2002). 
An ideal methodology to investigate such issues is the Hermeneutic Single Case Efficacy 
Design (HSCED; Elliott, 2002), which is a critical and interpretive approach to assess the 
intervention effects for single therapy cases in a naturalistic clinical setting. There are 
longstanding arguments whether psychotherapy operate through modality specific factors 
(ACT in this study), or through non-specific factors common to all psychotherapies (e.g. the 
therapeutic alliance or a client’s expectations of treatment; Mulder, Murray & Rucklidge, 
2017). It is also important to recognise the impact that events outside of the therapy session, 
extra-therapeutic factors, have on change within the client (e.g. a significant loss, change in 
medications). The HSCED acknowledges that there are numerous factors which contribute 
towards change (modality-specific, non-specific and extra-therapeutic), and it actively seeks 
to measure and analyse these. The utilisation of a case series (rather than individual case 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
study) allows for a cross-synthesis of what does and does not contribute towards change 
between-participants. 
This study provides an original contribution towards the field as it applies a therapeutic 
intervention (ACT) that is under researched within the older adult population. Furthermore, it 
utilises a methodology that is not only ideal in addressing the complex processes of efficacy, 
but which has also never been used to investigate ACT with older adults experiencing 
psychological distress. 
STUDY OBJECTIVES AND PURPOSE 
PURPOSE 
The purpose of the study is to examine whether ACT can be an effective intervention in 
increasing quality of life in older adults (aged 65+), presenting to older adult mental health 
service with psychological difficulties, as well as why ACT is effective. 
PRIMARY OBJECTIVE 
In this study we aim to investigate the efficacy of ACT for supporting older adult clients 
experiencing psychological distress. 
SECONDARY OBJECTIVE(S) 
In addressing the primary objective, we will be guided by three fundamental questions: (1) 
Do (meaningful) changes occur for client-participants over the course of ACT intervention? 
(2) Are observed changes broadly attributable to the ACT intervention? (3) What specific 
factors (ACT-specific, non-specific, extra-therapeutic) contribute to observed changes? 
The study will also identify adaptations that may be facilitative of change when using ACT 
with older adult clients, with consideration of the impact that moving the study to a 
telephone/videocall delivered intervention. 
OUTCOME MEASURES 
PRIMARY OUTCOME MEASURE 
1. Change in quality of life assessed using the Older People’s Quality of Life 
questionnaire (OPQOL-brief; Bowling, Hankins, Windle, Bilotta, & Grant, 2013). 
Completed by participant. 
SECONDARY OUTCOMES 
Symptom measures 
1. Client’s level of cognitive functioning assessed using the Montreal Cognitive 
Assessment (MoCA; Nasreddine et al., 2005). Completed by MHSOP team with the 
participant. 
2. Changes in symptoms of anxiety and depression assessed with the Hospital Anxiety 
and Depression Scale (HADS; Zigmond & Snaith, 1983). Completed by the 
participant. 
Change measures 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
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1. Change in/progress on client’s goals assessed using the Simplified Personal 
Questionnaire (PQ; Elliot, Mack, & Shapiro, 1999). Completed by participant with 
guidance from therapist. 
2. Client’s attribution of change and view on therapy assessed with the Change 
Interview (Elliott, Slatick, & Urman, 2001). Conducted by secondary researcher with 
participant. 
Process measures 
1. Change in psychological flexibility assessed using the CompACT-8 (Morris, Dawson, 
& Golijani-Moghaddam, 2019). Completed by participant. 
Session measures 
1. Change in client’s weekly level of quality of life assessed using the Outcome Rating 
Scale (ORS; Miller, Duncan, Brown, Sparks & Claud, 2003). Completed by 
participant. 
2. Change in therapeutic alliance assessed with the Session Rating Scale (SRS; 
Duncan et al., 2003). Completed by participant. 
3. Client’s (qualitative) views on individual therapy sessions assessed with the Helpful 
Aspects of Therapy form (HAT; Llewlyn, Elliott, Shapiro, Firth, & Hardy, 1988). 
Completed by therapist in discussion with participant. 
Fidelity measure 
1. Adherence to ACT related processes assessed with the ACT Fidelity Measure (ACT-
FM; O'Neill, Latchford, McCracken & Graham, 2019). Completed by therapist and 
secondary researcher. 
EXPLORATORY OUTCOMES 
Adaptations made to treatment will be recorded so that commentary can be made on what 
adaptations to ACT may be beneficial for older adult clients. Consideration of the impact that 
delivering the intervention in a remote manner will also be made and any adaptations that 
were made to facilitate this. 
TABLE OF OUTCOMES  
Objectives 
Outcome Measures  
Timepoint(s) of evaluation of 
this outcome measure (if 
applicable) 
Primary Objectives 
1. Quality of life (OPQOL-
brief). 
1. Baselines, pre-, mid- and 
post-intervention, and at 
six-week follow up. 
Secondary Objectives 
Symptom measures 
1. Cognitive functioning 
(MoCA). 
2. Changes in levels of 
anxiety and depression 
(HADS). 
 
1. At initial contact, by 
service as standard 
practice. 
2. At initial contact, by 
service as standard 
practice. Baselines, pre-, 
mid- and post-intervention, 

 
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and at six-week follow up.
 
Change measures 
1. Client’s goals (PQ). 
2. Client’s view on change 
(Change Interview). 
 
1. Prior to each weekly 
treatment session. 
2. One week after finishing 
treatment. 
 
Process measure 
1. Psychological flexibility 
(CompACT-8).  
 
 
1. Baselines, pre-, mid- and 
post-intervention, and at 
six-week follow up. 
 
 
Session measures 
1. Quality of life/general 
outcomes (ORS).  
2. Therapeutic alliance 
(SRS). 
3. Client’s views on the 
therapy session (HAT). 
 
1-3. At the end of each weekly 
treatment session. 
 
 
Fidelity measures 
1. Fidelity of treatment 
(ACT-FM). 
 
1. At the end of each session 
(by therapist) and random 
sampling of all sessions (by 
Secondary Research 
Supervisor). 
Exploratory/Tertiary 
Objectives 
 
 
1. Beneficial adaptations for 
ACT. 
2. Impact of 
telephone/videocall and 
adaptations to this. 
 
1. Noted throughout the study 
by researcher and 
commented on in final write 
up. 
2. Noted throughout the study 
by researcher, factored into 
impact of results, and 
commented on in final write 
up. 
 
STUDY DESIGN  
To address the aims and sub-objectives listed previously, the study will employ an 
adjudicated Hermeneutic Single Case Efficacy Design (HSCED) series. Following Elliott’s 

 
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published, or used by others persons without prior written authorisation from the University of Lincoln 
(2002; Elliott et al., 2009) approach, the first step for a HSCED is the formation of rich case 
records. Developed for each client, these consist of data from various time points in the 
study, and include demographic, quantitative (outcome measures, treatment fidelity 
measures etc.) and qualitative sources (Change Interview, therapy feedback, therapy 
process notes and recordings). The rich case records are then cross-referenced and 
synthesised into an affirmative and sceptic brief. These briefs are then presented to an 
expert panel to be adjudicated on the process of change (see Figure 1). 
 
Figure 1: the HSCED process (Stephen et al., 2011).  
Affirmative brief 
The purpose of the affirmative brief is to demonstrate direct links between the therapeutic 
intervention and outcomes, and is divided into three parts: 1) a brief of the main lines of 
argument for these links; 2) a rebuttal against the arguments made in the sceptic brief; and 
3) a concluding summary narrative (Stephen et al., 2011). The affirmative brief draws 
evidence from five areas (see Table 1), with evidence in at least two areas required to 
warrant adjudication (Elliott, 2002). 
Sceptic brief 
The opposing sceptic brief demonstrates possible nontherapy processes which could 
account for change (Table 2), and uses the same structure of a brief, a rebuttal, and a 
narrative summary. Elliott (2002) talks about the sceptic brief being developed in a manner 
of good-faith to determine what non-therapy effects may have led to change. 
DATA ANALYSIS  
To facilitate the cross-referencing of rich case records, several methods of analysis will be 
employed, dependent on the evidence area required for the affirmative or sceptic brief. 
These are outlined in Tables 1 and 2, respectively. All analyses will be completed using 
SPSS (Version 25.0; IBM Corp, 2017) or Microsoft Excel (Version 15.0.5179.1000; Microsoft 
Corporation, 2013). Analyses will be performed by the student researcher/therapist either at 
the MHSOP or the Universities of Lincoln or Nottingham. No data containing confidential 
information will be analysed outside of the MHSOP, in line with relevant NHS Trust policies.  

 
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Table 1 
Direct evidence for links between therapy process and outcome, from Elliott (2002). 
Direct evidence area 
Description 
Method of evaluation 
(specific analysis method) 
1. Retrospective 
attribution 
Change attributed by client to 
the therapy 
Content of Change Interview 
(Framework Analysis) 
2. Process-outcome 
mapping 
Content of post-therapy 
changes correspond to specific 
processes within therapy 
Correlations between within 
therapy measures (HAT), and 
quantitative outcome 
measures (Pearson 
correlation, or Spearman 
correlation if assumptions of 
normal distribution not met). 
3. Within-therapy 
process-outcome 
correlation 
 
In-therapy process variables 
covary with week-to-week 
changes in client problems 
Correlations between ACT 
adherence and ORS, and the 
change questionnaire (i.e. the 
SPQ; Pearson/Spearman 
correlation) 
4. Early change in 
stable problems 
Therapy coincides with 
changes in long-standing client 
problems 
Change in outcome measures 
from baseline to initial 
sessions (Pearson/Spearman 
correlation, visual analysis) 
5. Event-shift 
sequences 
Important events precede 
stable shifts in client problems, 
especially if therapy process 
and client change are logically 
related 
Correspondence between 
within therapy measure (HAT) 
and variation in patient’s 
problem (SPQ; 
Pearson/Spearman 
correlation, visual analysis) 
Note: HAT – Helpful Aspects of Therapy form. SPQ – Simplified Personal Questionnaire. 
 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
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Table 2 
Evidence for links between nontherapy processes and outcome, from Elliott (2002) 
Nonchange/ 
nontherapy area 
Changes are… 
Method of evaluation (analysis method) 
1. Non-improvement 
Either trivial or negative. 
Assess reliable and clinical significance on 
measures (RCI calculations); ask ppt the 
importance and direction of any change 
(Change Interview). 
2. Statistical artefacts 
Reflect measurement 
error, outlier to the mean, 
or experimentwise error. 
Assess for reliable change (RCI 
calculations); stability of client problems 
through multiple baselines 
(Pearson/Spearman correlation, visual 
analysis); replication of change over 
multiple measures (RCI calculations). 
3. Relational 
artefacts 
Superficial artefacts 
related attempts to 
please 
therapist/researcher. 
Evaluate client social desirability and 
determine covariance with measures 
(ANCOVA); ask ppt their negative and 
positive descriptions of therapy (Change 
Interview). 
4. Client expectations
Related to expectations 
or wishful thinking. 
Assess client expectations at start; ask ppt 
whether changes were expected or 
surprising (Change Interview). 
5. Self-correction 
Reflect self-help or self-
initiated remedy of 
temporary problems. 
Determine direction and stability of 
measures from baseline to initial sessions 
(Pearson/Spearman correlation); ask ppt 
duration of problems using SPQ; look for 
self-help efforts begun before therapy via 
demographics form and assessment. 
6. Extra-therapy life 
events 
Attributed to life events, 
e.g., changes in clients’ 
situation. 
Monitor for such events; assess likelihood 
of change without therapy (Change 
Interview); consider mutual influence these 
factors have on each other. 
7. Psychobiological 
factors 
Attributed to medication, 
medical illness recovery 
etc. 
Collect information on medication and 
physical health prior to, and during 
therapy. 
8. Reactive effects 
Due to being in research, 
sense of altruism in 
client, relationship with 
researcher.  
Ask client directly about effects of 
research (positive and negative); use of 
external ratings; minimise research 
impact. 
Note: ANCOVA – Analysis of Covariance; RCI – Reliable Change Index (Jacobson & Truax, 
1991); SPQ – Simplified Personal Questionnaire (Elliot, Mack, & Shapiro, 1999); ppt – 
participant.

 
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published, or used by others persons without prior written authorisation from the University of Lincoln 
 
STUDY SETTING  
The study will be a single centre study, run from a Mental Health Service for Older People 
(MHSOP) at Lings Bar Hospital, Nottinghamshire.  
As standard practice for psychology referrals at the MHSOP, the initial assessment will be 
completed primarily by Dr Burrell, the Field Research Supervisor for the study. Dr Burrell will 
then screen psychology referrals for appropriate participants and inform them about the 
study. Following social distancing restrictions in place due to the SARS-CoV-2 outbreak, the 
MHSOP is currently only offering face-to-face appointments when necessary, offering 
telephone or videocall therapy appointment as a standard replacement. As such, the therapy 
in the current study will be offered by either telephone or videocall. At first contact, 
participants will be asked their preference and what technology provisions they have to 
facilitate videocalling (i.e. a smartphone or a laptop/PC with microphone and camera). The 
sessions will then be conducted using QHealth (MyMed Ltd, 2020), which is an NHS Digital 
and NHS England approved, centrally funded eConsultation supplier for the COVID-19 
response. The therapeutic intervention will be conducted by the student researcher/therapist, 
Jonathan O’Keeffe. Clinical supervision will take place between student researcher/therapist 
and Dr Burrell at the MHSOP. Weekly ACT supervision will be conducted between student 
researcher/therapist and Secondary Research Supervisor via telephone or face-to-face. 
SELECTION OF PARTICIPANTS 
ELIGIBILITY CRITERIA 
To be eligible for the study, participants must have first been referred to the MHSOP for 
psychological support. The study will recruit both male and female participants, aged 65 
years or older (there is no upper age limit). 
Inclusion Criteria  
1. Be at least 65 years of age. 
2. Score at least 8 on the Hospital Anxiety and Depression Scale (HADS; Zigmond & 
Snaith, 1983) on either the anxiety or depression sub-scale. The HADS is an 
outcome measure already used by the MHSOP. 
3. Be referred to the MHSOP for psychological support. 
4. Have capacity to give informed consent. 
5. Be willing to engage in one-to-one psychotherapy over telephone or videocall. 
Exclusion Criteria 
1. A score lower than 22-24 on the MoCA. This is to screen for a level of cognitive 
deficit, which cannot be accommodated for in the current study, due to the 
adaptations which will be required (e.g. review sessions, carer enrolment to support 
memory consolidation). Cut-off limit is dependent on the individual’s age and 
education history. The MoCA is administered by the MHSOP as standard practice. 
2. Not rated higher than Cluster 8 (Mental Health Clustering Booklet 2013/14, 
Department of Health), a categorisation based on the Health of the Nation Outcome 
Scale (HoNOS; Wing et al., 1998). Clusters higher than 8 are associated with clients 
presenting with symptoms of psychosis and it is felt that this level of mental health 
problem would cause serious heterogeneity between client cases. As standard 
practice, the MHSOP at Ling Bar Hospital will have rated the client prior to 
consideration for the study. 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
3. Inability to understand English to a level required to participate fully in the 
intervention. This is due to a lack of ability to benefit from the intervention without an 
interpreter, and the impact an interpreter would have on the non-therapeutic 
processes (e.g. alliance) being measured in this study. 
4. Not currently undertaking any other psychological therapy, talking therapy or 
counselling. This is due to the potential impact the other therapy could have on 
change and the inability to fully account for this. 
Sampling and size of sample 
The study will recruit up to four participants. Most Hermeneutic Single Case Efficacy Designs 
(HSCED) focus on one client (Stephen, Elliott, & Macleod, 2011). However, there have been 
recent calls to increase cross case synthesis to further validate the intervention being used 
(MacLeod, Elliott, & Rodgers, 2012). Three cases would fit with established guidelines for a 
single-case research series (Smith, 2012) and has shown to be feasible in previous HSCED 
research (e.g. Wall, Kwee, Hu, & McDonald, 2017). Drop-out or withdrawal would be a major 
concern with the current study, due to the extended participant contact time and the 
constraints on recruiting and treating further participants within schedule for Doctoral Thesis 
submission. With dropout rates around 25% (Grover, Dua, Chakrabarti, & Avasthi, 2018) 
recruiting up to four participants appears a sensible approach. A fourth participant will only 
be recruited up until July 2020, to allow for the completion of the intervention and 
requirements of submission for the Doctoral Thesis. 
Sampling technique 
The sample will be referrals from the MHSOP recruited in a convenience sampling method. 
As this study aims to reflect usual clinical practice, this is an adequate sampling method to 
recruit participants. 
RECRUITMENT 
Participants will be recruited from Rushcliffe Mental Health Service for Older People 
(MHSOP), Lings Bar Hospital, Nottinghamshire. The initial approach will be from a member 
of the patient’s usual care team. Potential participants will be informed about all aspects 
pertaining to participation in the study. 
 
It will be explained to the potential participant that entry into the trial is entirely voluntary and 
that their treatment and care will not be affected by their decision. It will also be explained 
that they can withdraw at any time, but attempts will be made to avoid this occurrence. In the 
event of their withdrawal it will be explained that their data collected so far may not be 
erased in accordance with the University’s Research Privacy Notice and information given in 
the Participant Information Sheet and we will seek consent to use the data in the final 
analyses where appropriate. 
 
Participant Payment  
Clients will be reimbursed for the aspects of the study which are additional to usual practice. 
This is the extra number of questionnaires they need to complete, plus attending the Change 
Interview after treatment sessions have ended. Participants will be provided a voucher of 
their choosing for £40. Participants will also be reimbursed travel to the Change Interview (if 
social distancing is relaxed by the end of the study). 
CONSENT  
Following standard practice during social distancing, verbal informed consent will be 
accepted from all participants before they enter the study. During a phone/videocall 

 
Page 18 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
psychology referral assessment with potential participants whom have been referred for 
psychology support, a member of the MHSOP will explain the details of the study and 
enquire whether they would be interested in taking part. Hard copies of the Consent Form 
(CF) and Participant Information Sheet (PIS) will be posted out to participants so they able to 
read through, before a follow-up call is made (around a week later, usually by the same 
member of the MHSOP) to reiterate a summary of the study and allow an opportunity for any 
questions relating to the study. Potential participants will then be asked whether they would 
consent to taking part in the study. Should the potential participant need more time to 
consider, they will be called back a week later. If potential participants verbally consent, at 
the time, or after a week, they will be asked whether they consent to each point on the CF in 
turn. A note of this will be made on the participants clinical notes. 
Should potential participants not consent to take part in the study, they will be offered usual 
care from the MHSOP (see STUDY FLOWCHART, below). 
The process for obtaining participant informed consent will be in accordance with the REC 
guidance, and Good Clinical Practice (GCP) and any other regulatory requirements that 
might be introduced.  
Should there be any subsequent amendment to the final protocol, which might affect a 
participant’s participation in the trial, continuing consent will be obtained using an amended 
CF which will be signed by the participant. 
 

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
STUDY PROCEDURES/REGIMEN 
STUDY FLOWCHART  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up call (roughly one week after) to answer any 
questions and ask if they consent to participate. 
DOES NOT CONSENT 
CONSENTS (CF 1.3) 
Verbal consent is 
recorded on their patient 
notes. Questionnaire 
Pack 1.1 is posted out to 
the client. 
Client is offered usual 
care from MHSOP. 
Screening: Client is referred to MHSOP and 
satisfies inclusion/exclusion criteria. 
Researcher calls 
participant. Dates for 
sessions are arranged. 
Questionnaire Pack 1.1 
completed over the phone, 
four times (Baselines 1-4). 
Participant receives up to 12 
sessions of ACT, delivered 
at by phone/videocall. 
Participant completes 
Questionnaire pack 1.1 
Change Interview 
conducted (1 week after 
end of ACT). 
IF, participant 
withdraws from 
study, option to 
either… 
Follow up (5 weeks after 
Change Interview). 
Questionnaire pack 1.1 
completed.
Up to one extra 
participant is 
recruited if within 
Recruitment 
window (July 
2020).  
Client informed about study during psychology referral 
assessment. PIS 1.3 and CF 1.3 are posted out if interested.

 
Page 20 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
RANDOMISATION AND BLINDING  
Participants in this study will not be randomised or blinded to any aspects of the study. The 
HSCED methodology allows for a naturalistic and transparent procedural approach to 
investigating psychotherapy efficacy. 
STUDY REGIMEN 
Screening and baseline 
At the time of recruitment, all potential participants will be active referrals at the Rushcliffe 
Mental Health Service for Older People (MHSOP), Lings Bar Hospital, Nottinghamshire. 
They will also have been referred for further psychology support (i.e. any referral that is felt 
would benefit from individual clinical psychology sessions). Eligible clients (see 
inclusion/exclusion criteria) will be informed (through discussion and Participant Information 
Sheet) about the study during a psychology referral assessment with a Clinical Psychologist 
from the MHSOP (Dr Ruth Burrell, Field Research Supervisor for the study), delivered by 
phone/videocall due to social distancing requirements. Adaptations such as larger font to 
sheets will be determined as well as whether they would be able to facilitate videocall 
therapy. Potential participants that are interested in taking part will have the CF and PIS 
posted out to them, with a follow-up call around a week later to obtain consent. Clients that 
do not consent to take part will be offered usual care from the service. 
The Assistant Psychologist from the team will call those participants that consent to 
determine the dates of the intervention. The Assistant Psychologist will also go through a 
pack of questionnaires (Questionnaire Pack 1.1 [QP1.1]), which will have been posted out to 
them. This date will act as Baseline 1. The Assistant Psychologist will then call back a 
following three times, acting as Baselines 2, 3, and 4, all a week apart. Baseline 4 will ideally 
be the same day as the start of the Acceptance and Commitment Therapy (ACT) 
intervention. The ACT intervention will be conducted by the student researcher/therapist via 
telephone or videocall, depending on the participants wishes. Sessions will be audio 
recorded using an NHS encrypted electronic device, with participant knowledge, to conduct 
fidelity checks of the treatment at a later date. Participants will be supported to complete 
questionnaires after the session which will have been posted out to them. 
Therapeutic sessions 
Up to 12 therapeutic sessions will be offered, delivered by the student researcher/therapist. 
At session 1 (week 4), confidentiality will be reiterated, including under what circumstances 
confidentiality would be broken (risk to them or others). They will also be explained the 
procedure of clinical supervision from Dr Burrell as well as ACT-supervision from Dr Golijani-
Moghaddam (the latter supervision not using confidential information). Participants will then 
be supported to complete the Simplified Personal Questionnaire (SPQ), noting their 
expectations for therapy, the main problems they are bothered with and duration of these. 
Participants will then be introduced to the underlying concepts of ACT, before starting with 
the proposed ACT-protocol (adapted from Petkus & Wetherell, 2013): 
ACT area
Sessions and content
Values 
Sessions 1-3  
1. Regaining contact with values: What matters? 
2. The role of religion 
3. Making the most of the remaining time 
Acceptance/Willingness 
Sessions 4-5  

 
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ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
1. What's worked? What hasn't? What are the costs? 
2. Control is the problem 
3. Experiencing vs. avoiding 
4. How does this fit with values? 
Defusion 
Sessions 6-7  
1. Awareness of internal experiences 
2. A thought is just a thought 
3. Having a thought vs. content of a thought 
4. Defusion from damaged conceptualized self 
 
Mindfulness and Self as 
Context 
Sessions 8-9 (Mindfulness exercise conducted at the 
beginning of every session)  
1. Being in the present moment 
2. Not judging thoughts or feelings 
3. Thoughts and selves 
Committed Action 
Begins during the Values sessions and continues 
throughout the intervention, but is emphasized during 
Sessions 10-12  
1. What goals are consistent with values? 
2. What actions work toward these goals? 
3. Breaking it down into steps 
4. Problem-solving potential barriers 
5. Enlisting support 
Therapeutic blueprint 
 
Session 12 
1. Summary of the content  
2. Review of SPQ and any change experienced 
3.
Next steps and further support options 
 
Therapy will use the above protocol as a guide for treatment; however, duration and content 
will be adapted based on the individual. Primarily this will be using extra sessions to focus on 
any content that participants may need further work with, but could also include a break in 
the middle of sessions. Sessions will predominantly be weekly and one hour in length, 
dependent on any required adaptations. Sessions will be delivered either over telephone or 
via QHealth. As ACT is a processes-based therapy, rather than a single manualised 
procedural treatment, adherence to a strict protocol is not theoretically mandated (Hayes & 
Hoffmann, 2017).  
The basic structure of each session will be: 
1. Participant completes weekly Personal Questionnaire before session. 
2. Session begins with a mindfulness exercise. 
3. Homework and concepts from previous session are reviewed. 
4. New material for the session is covered. 
5. Homework is assigned. 
6. Therapist completed HAT with participant. 
7. Participant is supported to complete ORS and SRS. 
Following each session, the student researcher will receive clinical supervision with Dr 
Burrell by (secure) videocall or telephone to discuss any relevant case information, such as 

 
Page 22 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
risk and progress. A clinical note will be made on the participant’s electronic case record, as 
in standard practice. The student researcher will also receive regular ACT supervision from 
Dr Golijani-Moghaddam, Secondary Research Supervisor/Chief Investigator to address any 
modality specific questions or dilemmas. Relevant discussions from this will be added to the 
participant’s electronic case record as required. 
At mid-point in therapy (usually session six), QP1.1 will be repeated at the start of the 
therapy session. QP1.1 will also be repeated at the final therapy session to act as the post-
therapy time point.  
During the final session, the PQ will be re-administered to determine whether there has been 
any change in their problem areas. Participants will also be given the opportunity to ‘re-
author’ their problem areas. This is to capture any theoretical change they may have 
occurred in identifying where problems at situation, as would be posited by the ACT 
theoretical framework (living with problems, rather than eliminating them). Participants will 
complete any required session questionnaires prior to filing in the PQ. 
The final session will also cover a summary of the sessions, as well as providing the 
participant with a therapy blueprint of what they specifically found useful. This will include 
any next steps for the participant (e.g. whether they will continue to be seen by the MHSOP) 
and what the process is for them to follow if there is a deterioration in mental health. The 
participant will be reminded of the data processing details and asked again if they would like 
a summary of the findings from the study.  
One week after the final session, participants will complete a Change Interview, facilitated by 
Kiran Badesh, Trainee Clinical Psychologist, either face-to-face of by telephone/videocall, 
depending on the social distancing restrictions at the time. The Change Interview is a semi-
structured interview to determine whether the client experienced change during the 
treatment, what they attributed this towards (e.g. therapeutic factors, external factors). The 
Change Interview is completed by a member of the research team the participant has not 
had previous contact with (to encourage more honest responses), and will be recorded on a  
NHS encrypted device so that the answers can be transcribed at a later date. The 
participants will then receive reimbursement towards their travel (if applicable) and for the 
factors of research which were additional to normal clinical treatment (extra questionnaires, 
attending Change Interview). 
One month following the Change Interview, participants will be called up again by the 
Assistant Psychologist to complete QP 1.1. This will act as six-week post-therapy follow-up.  
Following final therapy sessions, a secondary member of the research team (likely to be the 
Chief Investigator) will complete fidelity checks to ensure that the modality (ACT) is 
sufficiently adhered to. This will be conducted using a random sampling method and the 
researcher will have access to anonymised audio files, stored on an encrypted NHS Trust 
device. 
Data from throughout the study will be cross-referenced to develop the affirmative and 
sceptic briefs required for the HSCED. Pseudonyms will be used for the participants and 
there will be no patient identifiable information within the briefs. Once completed, the briefs 
will be sent to the expert panel of three Clinical Psychologist, with relevant interest and 
experience of psychotherapeutic change methods. The panel adjudicate over the case 
material using a semi-structured questionnaire to decide whether the client made a 
substantial change and where they attribute this towards (ACT-specific, non-specific, or 
extra-therapeutic factors). This process allows for a reduction in researcher bias. 

 
Page 23 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, published, or used by others persons without prior written authorisation from 
the University of Lincoln 
 
SCHEDULE OF PROCEDURES 
Procedures 
Visits 
Psychology 
Screening 
Assessment 
& Baseline 1 
(wk1) 
Baseline 
2 
(wk2) 
Baseline 
3 
(wk3) 
Baseline 
4 & 
Session 1 
- pre 
(wk4) 
Sessions 
2-5 
(wks 5-8) 
Session 6 
- mid 
(wk 9) 
Sessions 
7-11 
(wks 10-
14) 
Session 
12  
- post 
 (wk 15) 
Change 
Interview 
(wk 16) 
Six wk 
follow-up 
(wk 20) 
Informed consent 
x 
 
 
 
 
 
 
 
 
 
Symptom, & 
process measures 
x 
x 
x 
x 
 
x 
 
x 
 
x 
Demographics 
x 
 
 
 
 
 
 
 
 
 
Medical history 
x 
 
 
 
 
 
x 
 
 
 
ACT intervention 
 
 
 
x 
x 
x 
x 
x 
 
 
Session, change, & 
fidelity measures 
 
 
 
x 
x 
x 
x 
x 
 
 
Change Interview  
 
 
 
 
 
 
 
 
x 
 
Note: wk = week; see Timetable of Measures for outline of when individual measures are administered. 
 
 

 
Page 24 of 33 
 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
WITHDRAWAL  
Participants may be withdrawn from the trial either at their own request or at the discretion of 
the Investigator. The participants will be made aware that this will not affect their future care. 
Participants will be made aware (via the information sheet and consent form) that should 
they withdraw the data collected to date may not be erased in accordance with the 
University’s Research Privacy Notice and information given in the Participant Information 
Sheet and may still be used in the final analysis. 
Stopping rules and discontinuation: 
-If a participant withdraws consent to continue.  
-If a participant expresses that the intervention is causing their anxiety and depression to get 
worse. 
-If a participant’s physical health significantly deteriorates to a point where continuation 
would be impractical or create sufficient negative burden on them. 
-If a participant fails to comply with the intervention. 
-If new findings become published regarding likely risks or negative effects of ACT. 
Should any of these criteria be met, the decision of whether the participant receives further 
support from the MHSOP will be decided by Dr Burrell and the wider MDT at the MHSOP. A 
replacement participant will be recruited, dependent of timeframe and ability to deliver 
therapy. Should criteria apply to all participants (such as evidence of the negative effects of 
ACT), the study as a whole will be temporarily stopped on ethical grounds. Interim analysis 
would be performed at this point to determine any negative effects of the intervention on the 
participants. Continuation of the study would be dependent on further guidance from the 
REC, NHS R&D and any other relevant parties. 
ETHICAL AND REGULATORY CONSIDERATIONS 
ASSESSMENT AND MANAGEMENT OF RISK 
This study aims to reflect usual clinical practice where possible; therefore, the burden to 
participants will be of a similar level to treatment as usual. That is, they will be expected to 
attend one-to-one psychotherapy (either face-to-face or at distance) and to discuss their 
mental health difficulties; what contributed towards the development of their difficulties; and 
what is maintaining their difficulties. As with any psychological therapy, there is a potential 
risk that talking about distressing experiences will cause an increase in frequency or 
intensity of pre-existing mental health conditions. 
These risks will be monitored through the study by the Trainee Clinical Psychologist (who is 
both researcher and therapist) through discussion with the participant, use of outcome 
measures and importantly by utilising weekly clinical supervision with Dr Burrell (Clinical 
Psychologist for the MHSOP). This allows a space for any concerns to be raised and for Dr 
Burrell to have clinical oversight of the participants. As part of standard clinical practice, and 
local NHS Trust policies, each participant will have a clinical risk assessment with the 
MHSOP. This will be reviewed by the researcher/therapist with Dr Burrell before starting 
therapy. Any relevant information will also be added to this, should anything relevant come 
up in therapy sessions. 

 
Page 25 of 33 
 
ACT OA: HSCED - Protocol Final Version 1.5 date 07.04.2020 
 
This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
The aspects of the study which are additional to usual practice are as follows: participants 
will be required to complete more questionnaires; participants will be required to come in for 
an interview after the block of therapy has ended. Every effort has been made to reduce the 
burden the questionnaires place upon participants. For instance, shorter questionnaires 
have been used where possible. Participants will also be asked about any adaptations 
required to complete questionnaires (e.g. larger font, someone completing questionnaires 
with them). Clients will be reimbursed for the aspects of the study which are additional to 
usual practice. 
The interviews in this study may include sensitive topics; however, there are no anticipated 
adverse events for participants. Should there be an increase in intensity of mental health 
difficulties then any immediate risk will be discussed in sessions.  The study will follow the 
Safeguarding policies and procedures of Nottingham Healthcare NHS Foundation Trust (the 
hosting Trust). In line with these procedures, should participants disclose anything to 
indicate that they or someone they know are at risk of harm, the researcher has a duty to 
report this. Participants will be informed of this where relevant and possible. 
Once participants have finished with the research aspects of the study, participants will 
either be discharged from the MHSOP or continue to receive support. This will be dependent 
on the client’s progress, any emergence of risk etc. Final clinical decision will be made by Dr 
Burrell, Clinical Psychologist/Field Research Supervisor, at the MHSOP. 
There are minimal risks to the researcher associated with this study, although therapy 
sessions may involve hearing distressing and emotive topics. The researcher will utilise both 
clinical supervision (through the MHSOP) as well as ACT focused supervision (though the 
University of Lincoln) to manage and monitor this.  
Individual participant medical information obtained as a result of this study are considered 
confidential and disclosure to third parties is prohibited with the exceptions noted. Medical 
information may be given to the participant’s medical team and all appropriate medical 
personnel responsible for the participant’s welfare.  
If information is disclosed during the study that could pose a risk of harm to the participant or 
others, the CI will discuss this with the Field Research Supervisor in the first instance and 
where appropriate report accordingly. 
ADVERSE EVENTS 
An adverse event (AE) is any untoward medical occurrence in a study participant. An 
adverse event (AE) may therefore be any unfavourable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease that develops or worsens during the study 
period.  
An AE may include: 
 
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency or intensity of the condition. 
 
Significant or unexpected worsening or exacerbation of the condition/indication under 
study. 
 
A new condition detected or diagnosed after study therapy administration even 
though it may have been present prior to the start of the study. 

 
Page 26 of 33 
 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
 
Pre- or post-treatment events that occur as a result of protocol-mandated procedures 
(e.g., invasive protocol-defined procedures, modification of a patient’s previous 
treatment regimen). 
An AE does not include: 
 
Medical or surgical procedures (e.g., colonoscopy, biopsy).  The medical condition 
that leads to the procedure is an AE. 
 
Social or convenience hospital admissions where an untoward medical occurrence 
did not occur. 
 
Day to day fluctuations of pre-existing disease or conditions present or detected at 
the start of the study that do not worsen. 
 
The disease/disorder being studied, or expected progression, signs, or symptoms of 
the disease/disorder being studied unless more severe than expected for the 
patient’s condition. 
Adverse events of participation in this study may be: there are no anticipated adverse events 
for participants associated with this study. 
A serious adverse event (SAE) means any adverse event, adverse reaction or unexpected 
adverse reaction, respectively, that: 
a. results in death, 
b. is life-threatening, 
c. requires hospitalisation or prolongation of existing hospitalisation, 
d. results in persistent or significant disability or incapacity, or 
e. consists of a congenital anomaly or birth defect 
Other ‘important medical events’ may also be considered serious if they jeopardise the 
participant or require an intervention to prevent one of the above consequences. 
NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the 
participant was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe. 
There are no serious adverse events anticipated with participating in this study.  
Participant reporting of adverse events 
The Investigator will review all documentation (e.g., hospital progress notes, laboratory, or 
diagnostic reports) relative to the event being reported.  The Investigator or clinician will then 
record all relevant information regarding an AE/SAE.  All adverse events will be recorded 
and closely monitored until resolution, stabilisation, or until it has been shown that the study 
treatment / intervention is not the cause. 
Participant removal from the study due to adverse events 
Any participant who experiences an adverse event may be withdrawn from the study at the 
discretion of the Investigator. 
ETHICS REVIEW AND COMPLIANCE  
The study shall not commence until the study protocol, information sheets and consent 
forms have been reviewed and approved from a Research Ethics Committee and relevant 
NHS/Social Care permission is obtained  

 
Page 27 of 33 
 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
The sponsor will be responsible for deciding whether amendments are substantial and non-
substantial in collaboration with the Chief Investigator.  
Where an amendment is required to study documentation that required REC approval, 
changes will not be implemented until REC approval and HRA categorisation is received. 
Where an amendment requires local approval, this shall be sought prior to the amendment 
be implemented at each site in accordance with the categorisation given on the HRA 
approval letter.  
Should an amendment be required to eliminate an apparent immediate hazard to 
participants this may be implemented immediately and the REC/HRA and R&D will be 
notified as soon as possible.  
Minor amendments for logistical or administrative purposes may be implemented 
immediately 
Amendments will be logged on the Sponsor’s Study Amendment Log and stored in the Trial 
Master/Site File(s).  
Annual Progress Reports shall be submitted to the REC within 30 days of the anniversary 
date on which the favourable opinion was given – until the end of the study.  
A final report shall (where possible) be submitted to the REC within one year after the end of 
the study.  
If the study is terminated prematurely the CI will notify the REC, including the reasons for 
premature termination.  
PEER REVIEW 
As part of the requirements for the DClinPsy course, this research has been through a 
number of stages in order to check it meets scientific quality. Two academic research staff, 
one from the University of Nottingham and one from the University of Lincoln, have formally 
reviewed the project protocol. The outcome was that it is of pass standard, feasible and of 
clinical importance. Progress since submission of the protocol to the course (May 2019) was 
assessed at the Research Annual Review (October 2019), where it was agreed that the 
research was progressing to the sufficient level. Prior to submission for IRAS approval for 
the study has also been sought from the Sponsor of the research (University of Lincoln) and 
Trust R&D where the research will take place (Nottinghamshire Healthcare NHS Foundation 
Trust). IRAS will also involve review by a REC panel. Once the study has finished, the same 
academic research staff will mark the Thesis before submission of journal article to a peer-
reviewed journal. This study will also be supported by the research team to ensure academic 
quality. 
PUBLIC & PATIENT INVOLVEMENT 
Participants will be provided a summary of the main findings from the study, should they 
request this when asked at the end of the study. A summary of the findings will also be 
presented to the Mental Health Service for Older People (MHSOP), where the study will be 
carried out. As the project is part of a Doctoral Thesis, a manuscript of the thesis will be 
stored on the University of Lincoln Repository, along with any journal articles that result from 
the study. 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
PROTOCOL COMPLIANCE 
Accidental protocol deviations may occur at any time. Accidental protocol deviations will be 
adequately documented on the relevant forms and reported to the Chief Investigator and 
Sponsor immediately.  
Therapy will use the ACT treatment protocol suggested by Petkus and Wetherell (2013), 
detailed above. However, this is only a guideline and may be adapted based on participant 
factors. As ACT is a processes-based therapy, rather than a single manualised procedural 
treatment, adherence to a strict protocol is not theoretically mandated (Hayes & Hoffmann, 
2017). Hayes & Hoffmann, 2017). Content of all sessions will be noted so that later process-
change analyses can be performed.  
Deviations from the overall study protocol which are found to frequently recur are not 
acceptable, these will require immediate action and could potentially be classified as a 
serious breach. 
DATA PROTECTION AND PATIENT CONFIDENTIALITY  
All study staff and investigators will comply with the principles of the Data Protection Act 
(2018) in protecting the rights of study participants with regards to the collection, storage, 
processing and disclosure of personal information and will uphold the Act’s/Regulations core 
principles.  
Each participant will be assigned a study identity number, for use on CRFs other trial 
documents and the electronic database. 
Personal data, research data and the linking code will be stored in separate locations. When 
stored electronically, this will include using encrypted digital files within password protected 
folders and storage media. Personal information shall be stored separately to research data 
and will be kept secure, and maintained.  
Personal data will be stored for six months following the end of the study, so that the Chief 
Investigator may provide participants with a summary of the research (should they wish to 
receive a copy). 
Data generated as a result of this study will be available for inspection on request by the 
participating physicians, the University of Lincoln representatives, the REC, local R&D 
Departments and the regulatory authorities. 
INDEMNITY 
Insurance and indemnity for trial participants and trial staff is covered within the NHS 
Indemnity Arrangements for clinical negligence claims in the NHS, issued under cover of 
HSG (96)48. There are no special compensation arrangements, but trial participants may 
have recourse through the NHS complaints procedures. 
The University of Lincoln as research Sponsor indemnifies its staff, research participants and 
research protocols with both public liability insurance and clinical trials insurance. 
ACCESS TO THE FINAL DATASET 
In compliance with the ICH/GCP guidelines, regulations and in accordance with the 
University of Lincoln Code of Practice for Research, the Chief or local Principal Investigator 
will maintain all records and documents regarding the conduct of the study. These will be 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
retained for at least five years or for longer if required. If the responsible investigator is no 
longer able to maintain the study records, a second person will be nominated to takeover 
this responsibility. 
Copies of the Trial Master File and trial shall be archived at secure archive facilities at the 
University of Lincoln. This archive shall include all trial databases, including transcripts of 
audio files and associated meta-data encryption codes. 
Personal data (such as contact details) will be destroyed after it is no longer necessary to 
contact a participant. Research data (including the consent form) will be retained for a period 
of five years following first publication. Recordings should be anonymised and archived with 
the research data as source data. 
DISSEMINATION POLICY 
The data custodian will be the Chief Investigator on behalf of the University of Lincoln. 
This study will be completed as part of a Doctoral Thesis in Clinical Psychology. A 
manuscript of the Thesis will be available from the University of Lincoln Repository. The 
Thesis manuscript will include a journal article which will be submitted for peer review, as 
well as extended information on relevant aspects of the study (e.g. methodology, design). 
The journal article will be submitted to the Journal of Contextual Behavior Science (JCBS), 
with anticipated date of July 2021. 
A summary of the main findings will be disseminated to participants involved in the study, 
should they indicate interest when asked. A summary will also be provided to the Mental 
Health Service for Older People that are hosting the research. 
Findings from the study will also be presented at any relevant conferences (e.g. related to 
Older Adults or Acceptance and Commitment Therapy), should there be an opportunity to do 
so. This would usually be in the form of a poster. 
 
 

 
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This protocol is confidential and the property of the University of Lincoln. No part of it may be transmitted, reproduced, 
published, or used by others persons without prior written authorisation from the University of Lincoln 
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