Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
Phase: NA
Conditions: Anxiety Disorders, Stroke, Transient Ischemic Attack
Sponsor: University of Edinburgh

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Non-CTIMP Study Protocol 
Treating Anxiety after StroKe (TASK)—feasibility randomized controlled 
trial 
 
 
 
Amendment classification and 
number: 
NA 
 
 
Summary of change(s) 
NA 
 
 
 
 
 
 
The University of Edinburgh and Lothian Health Board 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
Protocol authors 
Dr Ho-Yan Yvonne Chun, Dr Will Whiteley, Prof Gillian 
Mead, Prof Martin Dennis, Dr Alan Carson 
Funder 
Chief Scientist Office of Scotland 
Funding Reference Number 
CAF/15/07 
Chief Investigator 
Dr Ho-Yan Yvonne Chun 
Sponsor number 
AC17087 
REC Number 
228995 
Project registration 
 
Version Number and Date 
V3 1.12.2017  

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CONTENTS 
1 
INTRODUCTION .......................................................................................................... 7 
1.1 
BACKGROUND ................................................................................................... 7 
1.2 
RATIONALE FOR STUDY ................................................................................ 12 
2 
STUDY OBJECTIVES ................................................................................................ 13 
2.1 
OBJECTIVES .................................................................................................... 13 
2.1.1 
Primary Objective.......................................................................................... 13 
2.1.2 
Secondary  & Substudy Objectives ............................................................. 13 
2.2 
ENDPOINTS ...................................................................................................... 13 
2.2.1 
Feasibility outcomes ..................................................................................... 13 
3 
STUDY DESIGN ......................................................................................................... 14 
4 
STUDY POPULATION ............................................................................................... 16 
4.1 
NUMBER OF PARTICIPANTS .......................................................................... 16 
4.2 
INCLUSION CRITERIA ..................................................................................... 16 
4.3 
EXCLUSION CRITERIA .................................................................................... 16 
4.4      CO-ENROLMENT .............................................................................................. 16 
5 
PARTICIPANT SELECTION AND ENROLMENT ...................................................... 17 
5.1 
IDENTIFYING PARTICIPANTS ......................................................................... 17 
5.2 
CONSENTING PARTICIPANTS ........................................................................ 18 
    5.2.1   Withdrawal of study participants ................................................................. 19 
6 
STUDY ASSESSMENTS ........................................................................................... 20 
6.1 
STUDY ASSESSMENTS ................................................................................... 20 
7 
DATA COLLECTION ................................................................................................. 21 
7.1 
Source Data Documentation ........................................................................... 23 
7.2 
Case Report Forms .......................................................................................... 23 
8 
STATISTICS AND DATA ANALYSIS ........................................................................ 23 
8.1 
SAMPLE SIZE CALCULATION ........................................................................ 23 
8.2 
PROPOSED ANALYSES .................................................................................. 24 
9 
ADVERSE EVENTS ................................................................................................... 24 
10 
OVERSIGHT ARRANGEMENTS ............................................................................... 24 
10.1 
INSPECTION OF RECORDS ............................................................................ 24 
10.2 
RISK ASSESSMENT ......................................................................................... 24 
10.3 
STUDY MONITORING AND AUDIT .................................................................. 24 
11 
GOOD CLINICAL PRACTICE .................................................................................... 25 
11.1 
ETHICAL CONDUCT......................................................................................... 25 
11.2 
INVESTIGATOR RESPONSIBILITIES .............................................................. 25 
11.2.1 Informed Consent ......................................................................................... 25 
11.2.2 Data Recording ............................................................................................. 25 
11.2.3 Investigator Documentation ......................................................................... 25 
11.2.4 GCP Training ................................................................................................. 25 
11.2.5 Confidentiality ............................................................................................... 25 
11.2.6 Data Management and Data Protection ....................................................... 26 
12 
STUDY CONDUCT RESPONSIBILITIES ................................................................... 28 

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12.1 
PROTOCOL AMENDMENTS ............................................................................ 28 
12.2 
MANAGEMENT OF PROTOCOL NON COMPLIANCE .................................... 28 
12.3 
SERIOUS BREACH REQUIREMENTS ............................................................. 28 
12.4 
STUDY RECORD RETENTION ......................................................................... 28 
12.5 
END OF STUDY ................................................................................................ 28 
12.6 
CONTINUATION OF TREATMENT FOLLOWING THE END OF 
STUDY .............................................................................................................. 28 
12.7 
INSURANCE AND INDEMNITY ........................................................................ 28 
13 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ........................ 29 
13.1 
AUTHORSHIP POLICY ..................................................................................... 29 
14 
REFERENCES ........................................................................................................... 29 
 

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LIST OF ABBREVIATIONS 
 
ACCORD 
Academic and Clinical Central Office for Research & Development - Joint office 
for The University of Edinburgh and Lothian Health Board 
AE 
Adverse Event 
AR 
Adverse Reaction 
CBT 
Cognitive behavioural therapy 
CI 
Chief Investigator 
CRF 
Case Report Form 
EQ5D5L-
VAS 
EuroQol 5D 5L Visual Analogue Scale 
FQ 
Fear Questionnaire 
GAD 
Generalized Anxiety Disorder 
GAD-7 
7-item Generalized Anxiety Disorder Questionnaire 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
mRS 
Modified Rankin Scale 
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
RCT 
Randomized Controlled Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SOP 
Standard Operating Procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TIA 
Transient Ischaemic attack 

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1 
INTRODUCTION 
1.1 
BACKGROUND 
 
Anxiety affects around a quarter of stroke patients and can be disabling. A Cochrane review 
in 2017 concluded that the three randomized controlled trials (RCT) of anxiety intervention in 
stroke carried high risk of bias and were of small sample size, thus provided insufficient 
evidence to guide treatment.  
We carried out an observational study using psychiatric interviews to determine the 
commonest anxiety subtypes and anxiety-provoking situations to inform the targets of a 
psychological intervention. Based on these findings we developed a complex intervention 
consisting of cognitive behavioural therapy (CBT) techniques specifically adapted to the 
anxiety issues reported by patients following a stroke or transient ischaemic attack: the TASK-
CBT intervention. 
Scientific basis for TASK-CBT 
Phobic disorder was the predominant anxiety subtype after stroke (Figure 1) in our 
prospective cohort (n=175), consistent with three earlier studies that conducted psychiatric 
diagnostic interviews (1). Phobic anxiety is characterized by fear disproportionate to defined 
situation(s) and marked avoidance. Generalized anxiety disorder (GAD) is persistent & 
unremitting anxiety about multiple daily events. In non-stroke populations, exposure therapy is 
effective at treating phobic disorders in RCTs(2), while GAD responds to selective serotonin 
reuptake inhibitors, short-term benzodiazepines, and/or other cognitive behavioural 
techniques e.g. cognitive restructuring, problem solving(3, 4). Anxiety disorder at 3 months 
post-stroke was associated with poorer functional independence and quality of life even in a 
mild stroke & TIA sample(5). 
We hypothesize that an intervention that does not target phobic anxiety after stroke is not 
effective at alleviating anxiety symptoms and will not improve functional independence and 
quality of life after stroke. 
Figure 1. Frequency of phobic disorder and GAD at 3 months after stroke (n=175) (5) 
 

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To include exposure therapy in CBT there must be defined feared situation(s)/ stimuli. We quantified in our observational 
study, for the first time, the common anxiety-provoking situations/stimuli and maladaptive cognitive patterns affecting 
stroke survivors (Figure 2), and their associated avoidant behaviour. These findings informed targets for cognitive 
restructuring and exposure techniques used in the TASK-CBT intervention.  
Figure 2. Common anxiety-provoking situations/stimuli in 38/175 with anxiety disorder)(5) 

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The TASK-CBT intervention and TASK-Relax (active comparator) 
TASK-CBT intervention: Telephone-guided web-based CBT  
There are two key modes of delivery within the TASK-CBT intervention:  
1) A course of 6 weekly telephone-guided sessions (30-40minutes each) delivered over 6-12 weeks using 
the ‘TASK therapist’s manual & record’. Therapist (any stroke health professional—stroke nurse, rehab 
therapist, stroke doctor) receives training by Dr Alan Carson. Therapist meets with Dr Carson and reviews 
record. All telephone-guided sessions are audio-recorded and transcribed to aid validation of the therapist’s 
record. 
2) TASK-CBT treatment website displays information, graphics, treatment videos, and online tasks covering all 
components of TASK-CBT  
 
 
 
 
The active comparator intervention: TASK-Relax website 
 
TASK-Relax is an online self-guided course of relaxation techniques.   
 
One telephone session (20 minute) at the start to guide participant how to use the TASK-Relax website 
 
The course is structured with 5 online tasks. An introductory video (with subtitles) provides simple instructions on 
how to use the TASK-Relax website throughout the trial period. 
 
The tasks contain videos of breathing exercise, muscle relaxation, relaxing imagery and sound clips to teach 
participants various relaxation techniques 
 
Participants are encouraged to take at least 5 minutes to practice a relaxation task daily in the long-term 
  
 
 
 
 
 
 
For participant’s experience, please visit xxxxxxxxxxxxx. 
 Temporary login:  xxxxxxxxxxxxx        password: xxxxxxxxxxxxx 
For participant’s experience, please visit xxxxxxxxxxxxxxxxx 
 Temporary login: xxxxxxxxxxxxx         password: xxxxxxxxxxxxxx 
 

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Additional features common to both TASK-CBT and TASK-Relax intervention 
 
Ongoing ‘anytime’ access to the allocated website up to the end of the TASK trial period 
 
Useful links to external stroke resources—Chest Heart Stroke Scotland and Stroke Association 
websites 
 
Regular text reminders to improve intervention adherence & completion of data collection in the 
TASK trial. The text reminders continue throughout the trial period until data completion at primary 
endpoint 
 
Every participant is informed they will receive access to the website given to the other group 
 
Every participant receives a TASK participant card as follow:  
 
 
 
 
 
 
 
 
TASK CBT participant 
card front 
TASK CBT participant 
card back 

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TASK-Relax 
participant card  front 
TASK-Relax 
participant card back 

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1.2 
RATIONALE FOR STUDY 
Research question  
Is it feasible to compare the effectiveness of the telephone-guided web-based TASK-CBT with web-
based self-guided TASK-Relax in a web-enabled randomized controlled trial? 
Why is this study important to patients, health service and current policies? 
Anxiety problems afters stroke are common and disabling. There is little research evidence to guide 
how to treat anxiety after stroke. Access to psychological care after stroke is difficult. We need to 
deliver an anxiety intervention to large number of stroke and TIA patients, efficiently and 
economically to ensure its long-term sustainability in the NHS. Our intervention is developed in line 
with the Scottish Mental Health Strategy for 2017-2027.  
Treatment to be tested 
We know that cognitive behavioural therapy (CBT) works for anxiety in people who have not had a 
stroke. Many anxiety issues reported by stroke patients can potentially be targeted by CBT. We 
developed CBT treatment that are specifically tailored to stroke survivors. Before we can provide 
TASK-CBT to a large population of stroke survivors, we need to test whether these treatments have 
any real benefits to patients in a clinical trial setting. 
Feasibility of our method to minimize bias in a RCT of psychological intervention 
The type of comparator group in an RCT of psychological intervention can influence effect size(6). 
Rather than using a ‘treatment as usual’ (TAU) or waitlist control as comparator, we are comparing 
group receiving TASK-CBT & group receiving TASK-Relax (active comparator).  
Establishing any harms of our intervention 
It is not clear, but important to establish whether there is any potential harm of a telephone-guided 
web-based CBT intervention for stroke and TIA patients. We will do that by asking participants to 
complete a feedback survey at the end of the study period. 
Feasibility in conducting a nationwide web-enabled RCT conducted by a single centre 
We designed the trial procedures with the view of conducting a large-scale clinical trial that will 
recruit nationwide from a single centre in the future. We will use the feasibility data from this present 
study to refine our trial design.  
 
Feasibility of measuring objective outcomes using a wrist-worn wearable device (a substudy) 
Wearable device can collect objective physiological and behavioural measures, complementing and 
potentially replacing self-reported outcomes used in clinical trials of a wide range of interventions in 

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stroke and TIA patients. In a substudy we will assess the feasibility and acceptability of the 
GENEActive Original device in a clinical trial setting of stroke and TIA patients with anxiety. 
 
2 
STUDY OBJECTIVES 
2.1 
OBJECTIVES 
2.1.1 Primary Objectives 
Objective 1: Feasibility of web-enabled RCT procedures 
Objective 2: Feasibility of TASK-CBT & TASK-Relax interventions 
Objective 3: To establish any harm arising from TASK-CBT or TASK-Relax interventions 
2.1.2 Secondary/ substudy objectives 
Objective 4: Feasibility of wearing wrist-worn device (GENEActiv) for up to 210 days 
 
2.2 
ENDPOINTS 
2.2.1 Feasibility outcomes 
For objective 1: Feasibility of trial procedures  
a) 
Feasibility of online ‘Sign up’ process & electronic informed consent form (ICF) 
i. 
Number of participants recruited per month  
ii. 
How were participants recruited? 
 Self-recruited via website (%) 
 Via website with TASK team’s assistance (%) 
 In person, not via website (%) 
iii. 
How did participants complete ICF? 
 Electronic ICF(%) 
o actually eligible (%) 
 Paper ICF (%) 
 
b) 
Feasibility of remotely confirming eligibility of potential participants with 3 different method 
               Time (in days):  date of randomization – date of data request made 
 
via TRAK  
 
via general practice request for summary sheet to be faxed/ emailed (via 
nhs email) to TASK researchers 
 
via Scottish Stroke Care audit  
 
c) 
Feasibility of online self-completed surveys at data collection time points (% completion) 
 
Pre-randomization (T0) 
 
At  end of intervention—between 6-12 weeks (T1) 
 
At primary endpoint between 20-30 weeks (T2) 
 

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      For objective 2: Feasibility of assessing intervention fidelity (delivering intended content)   
a) Data recorded by therapist on the ‘TASK-CBT Therapist’s manual & record’ (TASK-CBT 
only)  
 which content(s) has been delivered, and in which session  
 
b) A third person from outside the TASK research team validates the therapist’s record with 
anonymised transcript of audio-recording for each telephone session (TASK-CBT only) (% 
agreement) 
 
c) Website analytics to analyse usage of website content and videos (TASK-CBT & TASK-
Relax) 
 
Duration spent on each page of TASK-CBT website (minutes) vs TASK-
Relax  
d) Completion of online tasks (TASK 1 - 6): data automatically captured on RedCap (TASK-
CBT only) (%) 
 
 
      For objective 3: To establish any unwanted effects arising from TASK-CBT or TASK-Relax 
interventions 
 
                   a) Online participant feedback survey at the end of data collection at T2 
 
% participants found the allocated intervention helpful for their anxiety 
 
% participants reported unwanted effects from allocated intervention 
 
Free-text feedback 
 
     For Objective 4 (Substudy): Feasibility of wrist-worn device for measuring objective outcomes  
 
                   a) Duration of useable data from device in total (days) 
                   b) Practical issues on delivering and collecting the device by courier service/ recorded   
                       delivery at the start, and at 60 day intervals throughout the trial period (free-text) 
                         
 
                        

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3 
STUDY DESIGN 
 
A parallel randomized controlled trial comparing TASK-CBT and TASK-Relax  
 
Study schematic 
 
 
 
 
Method of masking/ blinding of participants to intervention allocation: 
o 
Participants are informed they will receive all TASK treatments designed for this trial by the 
end of the study period  
o 
Both interventions are referred to as TASK treatments in Participant Information Sheet (PIS)  
o 
The PIS electronic and paper versions) simply states that we are testing different treatments: 
ways to overcome anxiety, relaxation techniques, useful videos, weekly tasks, regular text 
reminders 
o 
Participants are not aware of what type of treatment is given to the other group until they get 
access to it after the primary endpoint 
 
 
The purpose of this design is to reassure participants that they are getting an active intervention 
  
 
Substudy of the wrist-worn device GENEActiv Original 
 
o 
The GENEActive Original device is a CE-marked wrist worn device used for in may research 
studies. https://www.activinsights.com/actigraphy/geneactiv-original/   
o 
The device measures light, temperature and acceleration data 
o 
Participants in this substudy are asked to try to wear this watch as continuously as possible 
for up to 60 days 

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o 
Simple instructions will be given to wear it on the non-paretic hand; avoid covering the light 
sensor; remove for shower/ bath and put it back on afterwards; remove if any skin irritation 
occurs and inform the TASK research team 
4 
STUDY POPULATION 
4.1 
NUMBER OF PARTICIPANTS 
 
We aim to recruit 40 participants into this feasibility RCT from NHS Lothian, 20 of whom for the 
substudy of the wrist-worn device 
4.2 
INCLUSION CRITERIA 
1. Diagnosis of stroke (ischaemic, haemorrhagic), probable or definite transient ischaemic attack 
(TIA) & ocular TIA 
 
For clinic patients diagnosis has to be at least one month ago 
 
For ward patients, at least one month after discharge to community  
2. Age 18 or over 
3. Has access to internet and telephone 
4. Has anxiety symptoms (at least one positive response to the 6 anxiety questions on the ‘Sign up 
form’) and would like to receive treatment 
5. Has capacity to give informed consent 
6. Able to talk on the telephone (assessed by research team + verbal fluency test on telephone) 
7. Living within Lothian (all EH postcodes and FK1) 
4.3 
EXCLUSION CRITERIA 
 
Non-English speaking 
 
Already taking part in a clinical trial of treatment (drug or non-drug) intended to improve psychosocial 
outcomes e.g. stress, anxiety, depression, emotionalism, fatigue, social functioning, quality of life (as 
taking part in our study would affect the results in another trial) 
 
        *Being on a mood altering medication is not an exclusion criterion in TASK. We record whether 
participant is on a mood-altering medication during our data collection. 
4.4 
CO-ENROLMENT 
 
 
Participants cannot be co-enrolled to other clinical trials of treatment (drug or non-drug) intended to 
improve psychosocial outcomes e.g. stress, anxiety, depression, emotionalism, fatigue, social 
functioning, quality of life as co-enrolment is likely to influence outcomes in these trials 
o 
Our study sign-up form includes a routine question on whether the potential participant has 
already enrolled onto another research study. This is verified by the TASK research team 
 
Co-enrolment in an observational study, including one measuring psychosocial outcomes is 
permitted, but we will ask participant to first consider the potential burden of taking part in more than 
one research study.  
o 
Burden of co-enrolment in another observational study on psychosocial outcomes 
 
Similar questionnaires 
 
Follow ups may coincide with telephone sessions within TASK-CBT intervention 
 
 
Once enrolled onto the TASK trial we will make an entry onto TRAK record  

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5 
PARTICIPANT SELECTION AND ENROLMENT 
5.1 
IDENTIFYING PARTICIPANTS 
There are two methods of identifying potential participants. All methods encourage potential 
participants to visit the TASK recruitment website www.task4stroke.org where potential participants 
can begin the online sign up process themselves.  
 
Recruitment method 
 
 
For participant’s experience, please visit www.task4stroke.org  
 
 
i) 
Prospective recruitment:  
 
Participants who are identified as having anxiety symptoms by clinical staff or at 1-month 
telephone screening* are encouraged to visit www.task4stroke.org  
 
*part of clinical care, as recommended by the latest Royal College of Physician’s Guideline Fifth 
Edition 2016 (2.12.1).  
 
ii) Retrospectively:  
 
TASK researchers Dr Yvonne Chun, Prof Martin Dennis, Prof Gillian Mead, and Dr Will Whiteley 
are also part of the direct care team for stroke and TIA patients at the Royal Infirmary of 
Edinburgh. They will identify potentially eligible participants from the Scottish Stroke Care Audit 

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database and SHARE (www.registerforshare.org) and check eligibility on hospital electronic 
health system (TRAK). 
 
Letters of invitation and a ‘TASK business card’ will be sent to the potential participants on 
behalf of their treating physician. The letter advises patients to either seek GP advice or consider 
taking part in a clinical trial by visiting www.task4stroke.org if they are experiencing anxiety 
issues 
 
We will publicise the TASK recruitment website www.task4stroke.org by disseminating TASK 
‘business card’, PIS widely across the stroke services as above, on social media and via stroke 
charities. 
                     TASK study recruitment website ‘business’ card 
 
 
 
 
 
 
 
 
 
Any interested potential participant can either 
i. 
sign up themselves using the ‘Sign up form’ on www.task4stroke.org  
ii. 
contact the TASK research team by phone/ email for assistance in completing the online ‘Sign 
up form’ or request its paper version  
5.2 
CONSENTING PARTICIPANTS 
There is a three-step ‘eligibility confirmation and consenting process’  
 
Three-step eligibility confirmation and consenting 
 
 
1 
2 
3 
 
TASK researcher phones potential participant, confirms eligibility and consent., 
countersigns electronic consent form and emails a copy to participant 
Start treatment 
www.tasktreatment2.org 
                  or  
www.tasktreatment3.org 

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1) Potential participant completes online ‘Sign up form’ which comprises of A) Eligibility checklist, B) 
Informed Consent Form (ICF), and C) Personal details 
 
2) TASK research team verifies participant’s details and eligibility on the ‘Sign up form’ by checking 
TRAK/Scottish Stroke audit/GP summary sheet 
 
3) TASK research team phones potential participant for final verification of identity, eligibility, and 
confirmed the potential participant has personally provided the electronic signature on the ICF. TASk 
researcher countersigns the electronic consent form, emails copy to participant 
 
 
Once 3) is completed, while still on the telephone with the participant the TASK researcher   
 
completes baseline data collection (including participant’s baseline [T0] survey)  
 
randomizes participant and provides login and password for the allocated treatment website 
 
schedule the first telephone session for TASK-CBT participants 
 
provides simple instructions for TASK-CBT and TAS- relax participants to log on to their 
treatment website 
The TASK researcher also 
 
sends participant an electronic copy of the fully signed informed consent form by email 
 
sends participant a TASK participant card for the allocated treatment by post 
 
Other considerations 
 
Interested potential participants are encouraged to read all the information on the PIS (website 
or paper), and take as much time as they need before completing the ‘Sign up form’ 
 
Paper version of the TASK study ICF is available on request 
 
Easy-access version of the ‘Sign up form’ is available online with text-to-speech function  
 
 
Potential participants with sight impairment should complete this version with assistance 
from family member/ friend  
5.2.1 Withdrawal of Study Participants 
Participants are free to withdraw from the study at any point or a participant can be withdrawn by one of the 
TASK trial investigators. If withdrawal occurs, the primary reason for withdrawal will be documented in the 
participant’s case report form, if possible. The participant will have the option of withdrawal from  
              (i)all aspects of the trial but continued use of data collected up to that point 
(ii) all aspects of the trial with removal of all previously collected data.   
(iii) all aspects of the trial with removal of previously collected  
 
 
 
 
 “Stopping rules” and “discontinuation criteria”  
 
Participant loses capacity during the study period 
 
 
 
 
 
 
 
 
 

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6 
STUDY ASSESSMENTS 
6.1 
STUDY ASSESSMENTS 
Who completes the 
assessment(s) 
T0: baseline  
(before randomization) 
T1: at end of 
intervention 
(6-10 weeks post 
randomization) 
T2 primary 
endpoint:  
(20-30wks post-
randomization)  
Participant 
Generalized Anxiety Disorder-7 
(GAD-7) 
Fear Questionnaire (FQ) 
Patient Health Questionnaire-2 
(PHQ-2) 
Modified Rankin Scale (mRS) 
EuroQol5D5L-Visual Analog Scale 
(EQ5D5L-VAS) 
GAD-7 
FQ 
PHQ-2 
mRS 
EQ5D5L-VAS 
On medication for 
mood or anxiety Y/N 
GAD-7 
FQ 
PHQ-2 
mRS 
EQ5D5L-VAS 
On medication for 
mood or anxiety 
Y/N 
Participant 
feedback on first 
intervention  
TASK-CBT 
participant only 
Throughout the first intervention (TASK-CBT 
only): 
 
5 online TASKs--self-completed questions  
TASK researcher 
Demographics 
Date of index event 
Diagnosis 
Current psychiatric treatment 
Past medical history 
Past psychiatric history 
 
 
TASK Therapist 
Audio-recording of all 6 telephone-guided sessions Therapist’s manual & record’ 
Wearable device 
(GENEActiv) 
Wearable for the entire study period (20-
30 weeks) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7 
DATA COLLECTION 
 
All data collection, including the consent form is carried out online via electronic data collection 
instruments created in REDCap (Research electronic data capture, hosted by the University 
https://redcap.cir.ed.ac.uk/) 
 
The detailed security arrangements of REDCap are found in 11.2.7 
 
Our websites provide web links for participants to click on. Once clicked participants are taken to the 
relevant redcap web address to complete the questionnaire (see diagrams below). 
 
All personal data are stored on the REDCap database, hosted by the University of Edinburgh’s server 
(see 11.2.7) 
 
Other than the participant’s email address, no personal data are entered on the websites 
 
The following diagrams demonstrate how all of TASK trial’s data are collected from the initial ‘sign up’:  
 
1) The REDCap ‘Sign up form’ 
Potential participants are interested in taking part in the TASK trial and visits our website 
www.task4stroke.org  
 
By clicking on ‘Sign up form’ button participant is taken to a REDCap’s web address hosted by the 
University of Edinburgh, where participant can enter their details on the ‘sign up form’ 
 
All data entered are stored in the REDCap database at University of Edinburgh 
 
 
Visit www.task4stroke.org to see example of the ‘Sign up form’  
This form also comes in paper version as the TASK ICF  
 
On this REDCap ‘sign up form’ potential participants provide consent for us to contact them using 
their personal data which they provide on this form--surname, last name, date of birth, postal 
address, telephone number.  
 
 

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2) TASK researcher confirms consent and collect baseline (T0) data over the phone.  
 
TASK researcher  
o 
phones the potential participant who has completed the ‘Sign up form’ 
o 
confirms eligibility and consent over the phone 
o 
countersigns the electronic consent with an electronic signature 
o 
emails participant a copy of the countersigned consent form 
o 
collects baseline data from participant over the phone 
o 
randomizes the participant into one of two treatments 
o 
provides login instruction and email address to the treatment website 
o 
makes a telephone appointment (if allocated to the TASK-CBT group) 
 
3) The 5 online tasks on the TASK-CBT website (www.tasktreatment2.org) 
By clicking on each ‘TASK’ button participant is taken to the relevant REDCap web address hosted 
by the University of Edinburgh, where participant can complete a simple questionnaire. Diagram 
below shows what happens when participant clicks on ‘TASK 1’.  
 
Visit www.tasktreatment2.org (Temporary login: tasktrialteam@gmail.com  password: talt7061) to see 
these online tasks. 
 
 
4) Follow up surveys at T1 and T2 
We use the REDCap database management system to send participant an email (see example below) 
containing a link (url) to the follow up survey. Clicking on the link takes the participant to the REDCap 
survey at University of Edinburgh 
 

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 
To maximise completeness of data collection  
o we send a text reminder to each participant to complete each survey 
o each participant is posted a TASK participant card so they can record whether they have completed 
all three surveys and any online tasks 
o If surveys remain incomplete despite the above measures, TASK research team contact the 
participant to complete the survey over the telephone 
 
 
Wearable substudy participants are offered a brief report on the activity and sleep at the end of their 
participation 
 
 
7.1 
Source Data Documentation 
 
All study data are first captured electronically on REDCap and then printed as a pdf file to be filed as 
paper Case Report Form (CRF) to be stored in the Investigator Site File  (ISF) 
 
Any additional paper record of participant’s data e.g. GP’s summary sheet of past medical and drug 
history is stored with the paper CRF in the ISF 
7.2 
Case Report Forms 
 
Electronic CRFs are stored on REDCap database and printed as PDF files to be kept in physical 
storage in the ISF 
8 
STATISTICS AND DATA ANALYSIS 
8.1 
SAMPLE SIZE CALCULATION 
 
As this is a feasibility RCT designed for process evaluation, we did not calculate sample size  
 
We aim to recruit around 40 participants in this feasibility trial  

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8.2 
PROPOSED ANALYSES 
 
Feasibility endpoints as listed in 2.2.1 –these are summarized as proportions (%) and free text 
 
Descriptive data (mean, standard deviation) from clinical outcomes at T0, T1, T2  
o 
mRS, EQ5D5L-VAS, GAD-7, PHQ-2, FQ 
 
Between group differences in clinical outcomes 
 
Missing answers within each clinical outcome measure is unlikely as values must be provided to 
complete the electronic survey  
 
Non-completion—missing answers/ surveys despite all attempts to contact participant for 
completion  is a feasibility outcome in this trial 
 
Anonymised raw data obtained from the GENEActiv device in the sub-study are sent to data 
scientist (Dr Thanasis Tsanas) at the Usher Institute at University of Edinburgh for analysis  
9 
ADVERSE EVENTS 
 
It is possible that participants experience emotional distress, or worsening of their anxiety or mood 
during the TASK trial 
 
The TASK therapist is also a stroke physician and geriatrician with experience at delivering CBT in 
neurology patients. Stroke physicians are experienced in handling emotional sensitive topics and 
anxiety and will act in accordance with clinical needs of situation this may include postponing call 
for another day or on other occasions it may be appropriate to slightly prolong call in order to 
provide the required reassurance 
 
 
10 
OVERSIGHT ARRANGEMENTS 
10.1 INSPECTION OF RECORDS 
Investigators and institutions involved in the study will permit trial related monitoring and audits on behalf of 
the sponsor, REC review, and regulatory inspection(s).  In the event of audit or monitoring, the Investigator 
agrees to allow the representatives of the sponsor direct access to all study records and source 
documentation. In the event of regulatory inspection, the Investigator agrees to allow inspectors direct 
access to all study records and source documentation. 
 
10.2 RISK ASSESSMENT 
The Research Governance and QA office (University of Edinburgh) will review the study and determine if an 
independent risk assessment will be performed by an ACCORD Clinical Trials Monitor to decide (a) if 
monitoring is required and (b) if so, at what level. An independent risk assessment may also be carried out 
by the ACCORD Quality Assurance Group to determine if an audit should be performed before, during 
and.or after the study and if so, at what locations and at what frequency 
10.3 STUDY MONITORING AND AUDIT 
 
As 10.2. 
There is no data monitoring committee planned for this study 

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11 
GOOD CLINICAL PRACTICE 
11.1 ETHICAL CONDUCT 
The study will be conducted in accordance with the principles of the International Conference on 
Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP). 
Before the study can commence, all required approvals will be obtained and any conditions of approvals will 
be met. 
11.2 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for the overall conduct of the study at the site and compliance with the 
protocol and any protocol amendments.  In accordance with the principles of ICH GCP, the following areas 
listed in this section are also the responsibility of the Investigator.   
  
11.2.1 Informed Consent 
The Investigator is responsible for ensuring informed consent is obtained before any protocol specific 
procedures are carried out. The decision of a participant to participate in clinical research is voluntary and 
should be based on a clear understanding of what is involved. 
Participants must receive adequate oral and written information – appropriate PIS (online or paper version) 
and Informed Consent Form (ICF) (online or paper version) will be provided.  
The oral explanation to the participant will be carried out either via video of Chief Investigator on 
www.task4stroke.org, or in person by the Chief Investigator or qualified delegated person, and covers all the 
elements specified in the PIS and ICF. 
All interested potential participants are encouraged to take time to read through the TASK recruitment 
website including the electronic PIS before completing the ‘Sign up form’. They are encouraged to contact 
the TASK research team via telephone or email to clarify understanding. 
All interested potential participants can take as much time as they need before completing the ‘Sign up form’ 
The online recruitment video, our PIS (electronic and paper) and the ICF emphasize that the participant may 
withdraw their consent to participate at any time without loss of benefits to which they otherwise would be 
entitled. 
The participant will be informed and agree to their medical records being inspected by regulatory authorities 
and representatives of the sponsor(s). 
The TASK investigator countersigns the electronic ICF or paper ICF. The participant will receive a copy of 
this document electronically to their email and a paper copy is filed in the Investigator Site File (ISF). 
11.2.2 Data Recording 
The Chief Investigator is responsible for the quality of the data recorded in the CRF.  
11.2.3  Investigator Documentation 
 
This study is single-site only where all ISFs are stored 
11.2.4 GCP Training 
All researchers have undertaken GCP training  
11.2.5 Confidentiality 
All Investigators and the database manager involved with this study comply with the requirements of the 
Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal 
information and will uphold the Act’s core principles. Access to collated participant data will be restricted to 

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individuals from the research team, system administrators of the REDCap database, representatives of the 
sponsor(s) and representatives of regulatory authorities. 
 
Computers used to collate the data will have limited access measures via user names and passwords. 
Published results will not contain any personal data that could allow identification of individual participants. 
 
11.2.6 Data Management & Data Protection 
 
Personal data are only stored in REDCap (Research Electronic Data Capture) hosted by the University of 
Edinburgh https://redcap.cir.ed.ac.uk/ . 
Our participants provide us with their personal details, and give us informed consent to use these details to 
contact them in order to carry out the TASK trial. They provide us these personal details by completing the 
‘Sign up form’ (see Section 7), hosted by the University of Edinburgh.  
Web links (URLs) to these REDCap surveys are embedded in our websites and emails we send to 
participants. By clicking on these web links participants are taken to the secure REDCap surveys hosted by 
the University of Edinburgh 
The websites are hosted by wix.com and there are no databases built within our websites. The only piece of 
information required by wix to use the treatment websites is the participant’s email address and a password 
we create for the participant. If the participant would prefer not to use their personal email address, the TASK 
team is happy to recreate a new one to be used just for the TASK trial. No personal data (except email 
address) are stored on our websites/ wix.com. 
 
We hold all personal data in the REDCap database at the University of Edinburgh; As this is a clinical trial, 
data cannot be destroyed without sponsor approval. When the system has completed its purpose, and with 
sponsor’s approval all confidential personal information will be permanently destroyed/erased together with 
all hard or soft copies of the same, only the anonymised dataset will be archived and stored indefinitely due 
to its of long-term research value.  
 
REDCap 
All data collection instruments (including the ‘Sign up form’, online tasks, and participant surveys) of the 
TASK trial are created using REDCap (Research Electronic Data Capture). REDCap is run by the Surgical 
and Perioperative Health Research (SPHeRe), University of Edinburgh under licence from Vanderbilt 
University. REDCap was developed specifically around HIPAA-Security guidelines. It is hosted within the 
University of Edinburgh Virtual Machine architecture which is physically secured (for technical information 
see 
(http://www.ed.ac.uk/information-services/computing/computing-infrastructure/virtual-hosting/technical)                 
. Linux web servers running apache2/php5 host the application. Web browser communication to the server is 
SSL-encrypted by default. All other ports are firewall protected. Data is stored in MySQL databases on a 
separate server. This server is behind a firewall and can only be accessed from the IP address of the web 
server. An SSL tunnel encrypts communication between the web and databases servers. File upload is 
secured between servers using the WebDAV protocol with SSL. "At rest" encryption is in place on the 
database server. Daily back-ups are made of both servers and stored for two weeks prior to being deleted. 
Operating security updates are installed automatically. Antivirus software runs to a scheduled protocol on the 
web server. User passwords are managed directly. Accounts are disabled after 5 failed login attempts. Users 
are auto logged out after 30 mins of no activity. Users are forced to change password after 42 days. 
Password strength: AT LEAST 9 CHARACTERS IN LENGTH and must consist of AT LEAST one lower-case 
letter, one upper-case letter, and one number. Daily audit tracking of users is in place with removal of 
unused user accounts. 
Audit trails are kept automatically to monitor any activity or alterations made to the data and any of the data 
collection instruments. 
 
Physical records of participant data 
All physical records are kept in a locked cabinet in a ‘keypad’-locked office within the Centre for Clinical Brain 
Sciences (CCBS) which itself has restricted access to pass holders only.  The CCBS is a secure and 
alarmed building. Paper files are stored for 12 months after the end of the study and will then be destroyed 
confidentially.  

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Office best practice: Local policies are operated i.e. nightly clear desk, clear screen, locking of computer, 
password protection on screen savers, locking of file cabinets. 
 
Audio-recorded data and transcripts  
 
Audio-recording of telephone session using a digital recorder takes place within the CCBS. The digital 
recorder is stored in a locked cabinet in a ‘keypad’ locked office within the CCBS.  
Audio-recording is sent electronically to an external transcription service without any personal identifiable 
information. Transcription data will be held no longer than necessary; when the system has completed its 
purpose all confidential personal information will be permanently destroyed/erased together with all hard or 
soft copies of the same. Any storage media will be destroyed using contracted University of Edinburgh 
service. Only anonymised datasets will be archived indefinitely due to their long-term research value. 
 
Anonymised dataset will be retained/stored in perpetuity in the University of Edinburgh by the research 
team. 
 
Text messages via TASK team mobile phone 
Only Record ID is stored with the participant’s telephone number in the ‘Contacts’ of the TASK team mobile 
phone. When communicating via text messages no additional personal details other than the participant’s 
name are used. All text messages are erased weekly. At the end of the trial the TASK team mobile will be 
wiped using factory reset and sim card will be physically destroyed 
 
Wearable device-GENEActiv Original  
GENEActiv Original device does not carry any personal identifiable information. We record the serial number 
of each device given to participant to wear during the study. Any data recorded on the device will be lost in 
the event of the device being lost or stolen. The serial number can only be linked to the participant’s identity 
in our RedCap database. 
Data recorded on the device is downloaded and analysed at the Usher Institute at University of Edinburgh 
 
Website analytics (Wix & Googleanalytics) collect aggregate anonymised data  
 
Our TASK websites (www.task4stroke.org; www.tasktreatment2.org; www.tasktreatment3.org ) are hosted 
by wix.com—a commercial cloud-based web development platform for website building.  Like most website 
operators, Wix websites collect non-personally-identifying information of the sort that web browsers and 
servers typically make available, such as the browser type, language preference, referring site, and the date 
and time of each visitor’s request. These anonymised web usage data are collected by wix.com, and 
Googleanalytics. 
 
Participant’s email as login to our treatment websites 
We ask participants to provide only their email address in order to be used as a login for our treatment 
websites. Our research team can provide an alternative email login if participants do not wish to use their 
own. No personal data are entered onto the TASK websites. Both treatment websites 
www.tasktreatment2.org & www.tasktreatment3.org require this email login.  
We developed all of our TASK websites using Wix.com, industry’s leading cloud-based development 
platform. All three domains of our websites are purchased from Wix.com and connected to the Wix servers. 
All three domains have private registration in the WHOIS database.  
SSL Certificate 
All of the TASK websites (www.task4stroke.org; www.tasktreatment2.org; www.tasktreatment3.org) have a 
Secure Sockets Layer or SSL certificate. This allows our site visitors to view our sites over an HTTPS 
connection. It secures the connection between site visitor’s browser and the sites. 
 
 

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12 
STUDY CONDUCT RESPONSIBILITIES 
12.1 PROTOCOL AMENDMENTS 
Amendments will be submitted to a sponsor representative for review and authorisation before being 
submitted in writing to the appropriate REC, and local R&D for approval prior to participants being enrolled 
into an amended protocol. 
12.2 MANAGEMENT OF PROTOCOL NON COMPLIANCE 
Protocol deviations will be recorded in a protocol deviation log and logs will be submitted to the sponsors 
every 3 months. Each protocol violation will be reported to the sponsor within 3 days of becoming aware of 
the violation.  All protocol deviation logs and violation forms should be emailed to QA@accord.scot 
12.3 SERIOUS BREACH REQUIREMENTS 
If 
a 
potential 
serious 
breach 
is 
identified 
by 
the 
Chief 
investigator, 
the 
co-sponsors 
(seriousbreach@accord.scot) must be notified within 24 hours.  It is the responsibility of the co-sponsors to 
assess the impact of the breach on the scientific value of the trial, to determine whether the incident 
constitutes a serious breach and report to research ethics committees as necessary.  
12.4 STUDY RECORD RETENTION 
All paper study documentation will be kept for a minimum of 3 years from the protocol defined end of study 
point. When the minimum retention period has elapsed, study documentation will not be destroyed without 
permission from the sponsor. 
12.5 END OF STUDY 
The end of study is defined as the last participant’s completion of access to the second treatment website. 
Access to the second treatment website ceases about 10 weeks following primary endpoint.    
The Investigators or the co-sponsor(s) have the right at any time to terminate the study for clinical or 
administrative reasons.  
The end of the study will be reported to the REC, and R+D Office(s) and co-sponsors within 90 days, or 15 
days if the study is terminated prematurely. The Investigators will inform participants of the premature study 
closure and ensure that the appropriate follow up is arranged for all participants involved. End of study 
notification will be reported to the co-sponsors via email to resgov@accord.scot.  
A summary report of the study will be provided to the REC within 1 year of the end of the study. 
 
12.6 CONTINUATION OF TREATMENT FOLLOWING THE END OF STUDY 
Access to all TASK treatment websites ceases about 10 weeks following participant’s completion of data 
collection at primary endpoint  
 
12.7 INSURANCE AND INDEMNITY 
The Chief investigator and all co-investigators are either employed by the University of Edinburgh and NHS 
Lothian (honorary contracts). The NHS indemnity scheme will apply where an NHS contract (including 
honorary contracts) is in place. 
The protocol has been designed by the Chief Investigator and co-investigators employed by the University of 
Edinburgh. The University has insurance in place (which includes no fault compensation) for negligent harm 
caused by poor protocol design by the Chief Investigator and researchers employed by the University. 

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13 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS 
13.1 AUTHORSHIP POLICY 
We intend to publish the research findings in peer-review scientific journals within 1 year of the end of the 
study. A public summary will be available and emailed to our participants. 
Ownership of the data arising from this study resides with the study team.   
 
14 
REFERENCES 
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Knapp P. Frequency of anxiety after stroke: a systematic review and meta-
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Wolitzky-Taylor KB, Horowitz JD, Powers MB, Telch MJ. Psychological 
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psychology review. 2008;28(6):1021-37. 
3. 
Cuijpers P, Sijbrandij M, Koole S, Huibers M, Berking M, Andersson G. 
Psychological treatment of generalized anxiety disorder: a meta-analysis. 
Clinical psychology review. 2014;34(2):130-40. 
4. 
Stein MB, Sareen J. CLINICAL PRACTICE. Generalized Anxiety 
Disorder. The New England journal of medicine. 2015;373(21):2059-68. 
5. 
Chun HYW, W.; Mead, G.; Dennis M.; Carson, A. Anxiety after stroke: 
Importance of subtyping. Unpublished. 2017. 
6. 
Gold SM, Enck P, Hasselmann H, Friede T, Hegerl U, Mohr DC, et al. 
Control conditions for randomised trials of behavioural interventions in 
psychiatry: a decision framework. The Lancet Psychiatry.4(9):725-32.