Cognitive Remediation Group Therapy to Improve Older Adults' Ability to Cope With HIV-Associated Neurocognitive Disorder (HAND)
Phase: NA
Conditions: HIV/AIDS, Aging, Mild Cognitive Impairment, Group, Peer
Sponsor: University Health Network, Toronto

1 
 
 
FULL TITLE: 
IN HAND - Cognitive remediation group therapy to 
improve older adults’ ability to cope with HIV-
Associated Neurocognitive Disorder (HAND): A pilot 
randomized, controlled trial 
Protocol No. 
CTNPT 029 
Sponsor: 
University Health Network 
Principal Investigator(s): 
Mr. Andrew Eaton, AIDS Committee of Toronto (ACT), 
Factor-Inwentash Faculty of Social Work at the 
University of Toronto 
 
Sub-Investigators / 
Collaborators: 
Dr. Sharon L. Walmsley, Toronto General Research 
Institute (TGRI), University, Health Network (UHN) 
Dr. Shelley L. Craig and Dr. Barbara A. Fallon, Factor-
Inwentash Faculty of Social Work at the University 
of Toronto 
Dr. Sean B. Rourke, St. Michael’s Hospital, University 
of Toronto, Ontario HIV Treatment Network 
(OHTN) 
 
Study Support/ Funding: 
CIHR Canadian HIV Trials Network (CTN) 
 
 
ClinicalTrials.gov Identifier: <Type here> 
 
 
Version No. 
1.0 
Date: 
[31-October-2017] 
 
Compliance Statement 
This clinical study will be conducted in accordance with International Conference on Harmonisation (ICH) 
guidelines on current Good Clinical Practice (GCP), the Tri-Council Policy Statement Version 2 (TCPS2) 
and the Declaration of Helsinki. 
 
Confidentiality Statement 
This clinical study protocol contains information which is of a confidential, trade-secret or proprietary 
nature. The protocol is for the use of Andrew Eaton and his designated representatives participating in 
the investigational trial. It is not to be disclosed to any other person or party without the prior written 
approval of Andrew Eaton. 
 
 
 

2 
 
TABLE OF CONTENTS 
 
INVESTIGATOR AGREEMENT .......................................................................................................................................................... 4 
STUDY CONTACT DETAILS ......................................................................................................................................................................... 5 
ABBREVIATIONS AND DEFINITONS ............................................................................................................................................... 6 
PROTOCOL SYNOPSIS ...................................................................................................................................................................... 7 
STUDY FLOW CHART ......................................................................................................................................................................... 9 
1. 
INTRODUCTION, BACKGROUND, AND STUDY RATIONALE ......................................................................................... 10 
1.1 
BACKGROUND ...................................................................................................................................................................... 10 
1.2 
SELECTION OF HAND INTERVENTION MODEL ................................................................................................................... 11 
1.3 
STUDY RATIONALE .............................................................................................................................................................. 12 
1.4 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS ............................................................................................ 12 
2. 
STUDY OBJECTIVES AND DESIGN ..................................................................................................................................... 12 
2.1 
OVERALL STUDY DESIGN .................................................................................................................................................... 12 
2.2 
PRIMARY OBJECTIVES ......................................................................................................................................................... 12 
2.3 
SECONDARY OBJECTIVE ..................................................................................................................................................... 13 
2.4 
EXPLORATORY OBJECTIVES ............................................................................................................................................... 13 
3. 
SELECTION AND ENROLLMENT OF PARTICIPANTS ...................................................................................................... 13 
3.1 
NUMBER OF PARTICIPANTS ................................................................................................................................................. 13 
3.2 
INCLUSION CRITERIA ........................................................................................................................................................... 13 
3.3 
EXCLUSION CRITERIA .......................................................................................................................................................... 14 
3.4 
CONCOMITANT ALCOHOL AND “STREET” DRUG USE ......................................................................................................... 14 
3.5 
RECRUITMENT AND ENROLLMENT PROCEDURES ............................................................................................................... 14 
3.6 
CO-ENROLLMENT GUIDELINES ............................................................................................................................................ 14 
3.7 
SAMPLING AND RECRUITMENT ............................................................................................................................................ 14 
4. 
WITHDRAWAL OF PARTICIPANTS ....................................................................................................................................... 15 
4.1 
WITHDRAWAL CRITERIA ....................................................................................................................................................... 15 
4.2 
PROCEDURES FOR DISCONTINUATION................................................................................................................................ 15 
5. 
RANDOMIZATION PROCEDURE ........................................................................................................................................... 15 
5.1 
RANDOMIZATION .................................................................................................................................................................. 15 
6. 
THERAPY OVERVIEW ............................................................................................................................................................. 15 
6.1 
ARM 1: EXPERIMENTAL THERAPY ....................................................................................................................................... 15 
6.2 
ARM 2: ACTIVE CONTROL ................................................................................................................................................... 16 
7. 
RISKS AND PRECAUTIONS ................................................................................................................................................... 16 
7.1 
RISK MANAGEMENT ............................................................................................................................................................. 16 
7.2 
MENTAL HEALTH SUPPORT ................................................................................................................................................. 16 
8. 
CLINICAL EVALUATIONS ........................................................................................................................................................ 16 
8.1 
QUESTIONNAIRES ................................................................................................................................................................ 16 
9. 
STUDY PROCEDURES ............................................................................................................................................................ 17 
9.1 
SCHEDULE OF EVENTS ........................................................................................................................................................ 17 
9.2 
SCREENING PERIOD PROCEDURES/ASSESSMENTS ........................................................................................................... 18 
9.2.1 
Screening Call [Visit no. -3] ........................................................................................................................................ 18 
9.2.2 
Screening Visit [Visit no. -2] ........................................................................................................................................ 18 
9.2.3 
Baseline Visit [Visit no. -1] .......................................................................................................................................... 19 
9.3 
STUDY PERIOD PROCEDURES/ASSESSMENTS ................................................................................................................... 19 
9.3.1 
Study Arms .................................................................................................................................................................... 19 
9.3.2 
Facilitator Meeting [Visit no. 0] ................................................................................................................................... 19 
9.3.3 
Therapy Sessions 1, 2, 3, 4, 5, 6, 7, 8, 9 & 10 [Visit no. 1, 2, 3, 4, 5, 6, 7, 8, 9, & 10] ...................................... 19 
9.4 
FOLLOW-UP PERIOD PROCEDURES/ASSESSMENTS .......................................................................................................... 20 

3 
 
9.4.1 
FOLLOW-UP VISIT [VISIT NO. 11] ........................................................................................................................................ 20 
9.5 
END OF STUDY VISIT [VISIT NO. 12] ................................................................................................................................... 20 
9.6 
EARLY TERMINATION ........................................................................................................................................................... 20 
10. 
STATISTICAL CONSIDERATIONS .................................................................................................................................... 20 
10.1 
GENERAL STUDY DESIGN ................................................................................................................................................... 20 
10.2 
SAMPLE SIZE CONSIDERATIONS/JUSTIFICATION ................................................................................................................ 21 
10.2.1 
Efficacy: Intent-to-Treat .......................................................................................................................................... 21 
10.3 
ANALYSIS OF DEMOGRAPHIC AND BASELINE DATA ............................................................................................................ 21 
10.4 
ANALYSIS OF PRIMARY OUTCOME MEASURES ................................................................................................................... 21 
10.5 
ANALYSIS OF SECONDARY OUTCOME MEASURES ............................................................................................................. 21 
10.6 
OTHER ANALYTICAL ISSUES / CONSIDERATIONS ................................................................................................................ 21 
11. 
STUDY ETHICAL CONSIDERATIONS .............................................................................................................................. 21 
11.1 
ETHICAL CONDUCT OF THE STUDY...................................................................................................................................... 21 
11.2 
INFORMED CONSENT ........................................................................................................................................................... 21 
11.3 
CONFIDENTIALITY ................................................................................................................................................................ 22 
11.4 
INSTITUTIONAL REVIEW BOARD, ETHICS COMMITTEE, OR RESEARCH ETHICS BOARD .................................................... 22 
12. 
GENERAL TRIAL CONDUCT CONSIDERATIONS ......................................................................................................... 22 
12.1 
ADHERENCE TO PROTOCOL ................................................................................................................................................ 22 
12.1.1 
Protocol Deviations ................................................................................................................................................. 22 
12.2 
RECORD KEEPING ............................................................................................................................................................... 22 
12.2.1 
Data Collection......................................................................................................................................................... 22 
12.2.2 
Data Corrections ...................................................................................................................................................... 23 
12.2.3 
Source Documents .................................................................................................................................................. 23 
12.2.4 
Data Management ................................................................................................................................................... 23 
12.2.5 
Record Retention..................................................................................................................................................... 23 
13. 
DISCLOSURE AND PUBLICATION POLICY ................................................................................................................... 23 
14. 
REFERENCES ....................................................................................................................................................................... 24 
APPENDICES ...................................................................................................................................................................................... 27 
 
 

4 
 
INVESTIGATOR AGREEMENT 
 
Protocol Title: 
IN HAND - Cognitive remediation group therapy to improve older 
adults’ ability to cope with HIV-Associated Neurocognitive 
Disorder (HAND): A pilot randomized, controlled trial 
Protocol No.: 
CTNPT 029 
Version No.: 
1.0 
Date: 
31-Oct-2017 
 
This clinical study will be conducted in accordance with ICH guidelines on current GCP, the Tri-Council 
Policy Statement Version 2 (TCPS2) and the Declaration of Helsinki. 
 
I confirm that I have read and understand this protocol and I agree to conduct this clinical study in 
accordance with the design and specific provisions of the protocol, with the exception of a change 
intended to eliminate an immediate hazard to participants. Any deviation from the study protocol will 
be documented in the case report form. 
 
I agree to promptly report to the applicable ethics boards any changes in the research activity and all 
unanticipated problems involving risks to human participants or others. Additionally, I will not make any 
changes in the research without prior ethics and sponsor approval, except where necessary to ensure 
the safety of study participants. 
 
 
Andrew Eaton 
 
 
 
31-Oct-2017 
Name 
 
Signature 
 
Date (dd-mmm-yyyy) 
 
 

5 
 
STUDY CONTACT DETAILS 
 
Role 
Contact Details 
Principal Investigator 
Andrew Eaton – 416-340-8484 ext. 283 / aeaton@actoronto.org 
Co-Principal Investigator 
Sharon Walmsley – 416-340-3871 / Sharon.walmsley@uhn.ca 
Research Coordinator 
Galo Ginocchio – 416-340-8484 ext. 295 / gginocchio@actoronto.org 
Sponsor 
University Health Network (UHN) 
 
 
 

6 
 
ABBREVIATIONS AND DEFINITONS 
 
Acronym / Abbreviation 
Definition 
AIDS 
Acquired immune deficiency syndrome 
ANI 
Asymptomatic neurocognitive impairment 
ART 
Anti-retroviral therapy 
cART 
Combination anti-retroviral therapy 
CBR 
Community-based research 
CRGT 
Cognitive remediation group therapy 
DBT 
Dialectical behavioural therapy 
HAD 
HIV-associated dementia 
HAND 
HIV-associated neurocognitive disorder 
HIV 
Human immunodeficiency virus 
MBCT 
Mindfulness-based cognitive therapy 
MBSR 
Mindfulness-based stress reduction 
MND 
Mild neurocognitive disorder 
PLWH 
People living with HIV 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

7 
 
PROTOCOL SYNOPSIS 
 
Full Title 
IN HAND - Cognitive remediation group therapy to 
improve older adults’ ability to cope with HIV-
Associated Neurocognitive Disorder (HAND): A pilot 
randomized, controlled trial 
Short Title 
IN HAND 
Protocol No. 
CTNPT 029 
Study Duration 
Enrollment period: Three months 
Study period: Six months 
Sponsor  
University Health Network 
Number of Centres 
3 
Study Design 
Pilot; Parallel design randomized, controlled trial 
Primary Objective 
To compare the feasibility and acceptability of cognitive 
remediation group therapy (CRGT) against an active control as 
psychosocial treatment for older HIV-positive adults who have 
been diagnosed with mild-to-moderate HAND 
Secondary Objectives 
To determine the fidelity of the cognitive remediation group 
therapy (CRGT) model. 
Exploratory Objectives 
1. Change in stress, anxiety, and coping from pretest to 
posttest (between groups) 
2. Sustained use of brain training activities 
3. Change in use of mindfulness strategies (between 
groups) 
 
Sample Size 
N = 16 
Randomization 
1:1 
8 in the treatment group and 8 in the active control group 
Study Population 
HIV-positive people ≥ 40 years of age who have been living with 
HIV for more than 5 years and who have completed 
neuropsychological testing, received a diagnosis of Mild 
Neurocognitive Disorder (MND)  
Experimental Therapy Description 
Cognitive remediation group therapy: 10 weekly 3-hour 
sessions; each session is comprised of 45 minutes of tablet-
based cognitive training using PositScience, a 15-minute break, 
and 1.75 hours of Mindfulness-Based Stress Reduction (MBSR) 
with a 15-minute break halfway through the MBSR component. 
Active Control 
10 weekly 3-hour sessions with a 15-minute break at the end of 
each hour; each session is comprised of process-oriented 
facilitation using a mutual aid model (i.e., encouraging peer 
discussion of effects of HIV, aging, and cognitive impairment to 
identify and initiate coping strategies). 
Duration of Study 
Ten weeks 
Outcome Measures 
Primary: 
Feasibility: The sampling frame is approximately 100 people. 
The following targets (all based on a denominator of 100) would 
need to be met for a larger study to be considered feasible: 
>30% of those contacted agree to participate, >25% complete 
the pre-test, >20% attend the first session, >16% complete the 
full series and complete the post-test. Each participant must 
attend 80% (8/10) of the group sessions to be considered as 
completing the series. 

8 
 
Acceptability: The sampling frame will be described (i.e., age, 
gender, ethnicity, length of time living with HIV, length of HAND 
diagnosis, length of time since last HAND follow-up at St. 
Michael’s Hospital) in terms of those who agree and decline to 
participate. For those who cancel participation in the study, the 
research coordinator will follow-up by phone to ascertain the 
reason for attrition and this will be described, if the participant 
agrees. Participants will complete a standardized satisfaction 
scale (i.e., the Helping Characteristics of Self-Help and Support 
Groups Measure) that will be complemented by questions about 
session length, number of sessions, activities used, and 
evaluation of facilitators. 
Secondary: 
Intervention fidelity: Facilitators of both study arms will submit 
weekly session reports. These reports will include checklists of 
the therapy components; use of an average 80% of components 
listed will be considered as good fidelity. These reports will also 
include open-ended questions about the sessions, including 
questions on group dynamics, challenges faced, and detail on 
activities used. 
Exploratory: 
• 
Change in stress, anxiety, and coping. 
• 
Sustained use of brain training activities 
• 
Change in use of mindfulness strategies 
Scales/Questionnaires: 
• 
Anxiety in Cognitive Impairment and Dementia Scale 
• 
Coping Self-Efficacy Scale of Health Problems 
• 
HIV/AIDS Stress Scale 
• 
Five Facet Mindfulness Questionnaire—Short Form 
(FFMQ-SF) 
Statistical Analysis 
Depending on the nature of the exploratory results and the true 
sample size, non-parametric tests or a power analysis on the 
exploratory outcomes may be appropriate. 
 
 
 

9 
 
STUDY FLOW CHART 
 
 
 
 
 
Screening Visit 
(informed 
consent, 
availability, 
mobile device 
access) 
Facilitator 
meeting  
& 
Arm 2 =  
Active Control 
(10 consecutive 
weeks of 
standard of care 
HIV group 
therapy) 
Randomization into: 
Arm 1  
(n = 8 in 
Experimental)  
Or  
Arm 2  
(n = 8 in Active 
Control) 
Facilitator 
Meeting  
& 
Arm 1 = 
Experimental 
(10 consecutive 
weeks of novel 
cognitive 
remediation 
group therapy) 
Follow-up Visit 
(Post-
assessment) 
End of Study 
Visit 
(3 month follow-
up) 
Screening call 
Inclusion: 
1) Age ≥40  
2) ≥5 years living with HIV 
3) MND diagnosis 
4) Consented to future 
contact for research 
from St. Michael’s 
Hospital 
5) Can attend 10 weeks 
of group therapy in 
downtown Toronto 
Exclusion: 
1) Other significant 
psychiatric diagnosis 
2) ANI / HAD diagnosis 
3) Active intravenous 
drug / crystal meth use 
4) Hospitalization within 
past 30 days  
5) Inability to 
communicate in  
English  
6) Cannot use a tablet 
 
Number of refusals &  
Reasons for refusal  
(if possible) 
Chart Abstraction 
(demographics, 
medications, 
comorbidities from 
patient chart)  
 
Baseline Visit 
(study 
questionnaire) 

10 
 
 
1. 
INTRODUCTION, BACKGROUND, AND STUDY RATIONALE 
 
1.1 
 Background 
 
Cognitive impairment is a significant co-morbidity for people aging with Human Immunodeficiency 
Virus (HIV). It is estimated that approximately 50% of the aging HIV-positive population will be affected 
by HIV-Associated Neurocognitive Disorder (HAND) (Greene et al., 2015; Grant et al., 2014). HAND 
is diagnosed in three forms based on Frascati criteria: (a) Asymptomatic Neurocognitive 
Impairment (ANI) – evidence of neuropsychological impairment in at least two cognitive domains but 
no evidence of functional impairment or difficulty with daily functioning; (b) Mild Neurocognitive 
Disorder (MND) – evidence of impairment in at least two cognitive domains and evidence of subtle 
but significant functional daily impairments or difficulty with daily functioning (e.g., with work or in social 
situations); and (c) HIV-Associated Dementia (HAD) – evidence of marked impairment in several of 
all cognitive domains and evidence of significant functional daily impairments or difficulty with everyday 
functioning and activities of daily living (Antinori et al., 2007). If untreated, HIV-infected persons may 
progress through these stages in rapid succession as shown by high rates of HAD prior to the 
introduction of successful Combination Anti-retroviral therapy (cART) (Monforte et al., 2004). With the 
development and widespread use of modern cART, and the trend towards earlier treatment initiation, 
HAND is now less common and less severe, although still exists (Grant et al., 2014).  It is of particular 
concern in the Acquired Immune Deficiency Syndrome (AIDS) survivors – those who are currently 
aging with HIV, and who frequently were treated with incompletely suppressive antiretroviral regimens, 
medications that had higher rates of mitochondrial toxicity, and often after an AIDS defining illness or 
when the immune system was very weak (Antinori et al., 2013; Hopcroft et al., 2013). It is characterized 
by problems with cognition, memory deficits, difficulties in processing new information, impairment in 
executive function, errors in problem solving, poor decision making, etc (Spudich, 2013).  This in turn 
leads to stress, anxiety, social isolation, difficulty coping, and may impact every day functioning such 
as adherence to medication and paying bills. (Tedaldi, Minniti, & Fischer, 2015). HAND is thought to 
result from structural damage in the fronto-striatial-thalamatory circuits in the brain, and hence there is 
no cure (Heaton et al., 2010) Strategies such as a switch to cART combinations with better central 
nervous system penetration have not been successful (Heaton et al., 2010; Monforte et al., 2004). 
With the addition of the cognitive decline of normal aging, HAND symptoms may become more 
apparent, further impairing the aging HIV-infected adult’s ability to cope (Eaton, Craig, & Wallace, 
2017; Hopcroft et al., 2013). 
 
Psychosocial interventions have been studied in the general aging population with cognitive 
impairment and depression with the goal to decrease stress and depression and improve coping, daily 
functioning, and quality of life. Given success of these interventions in that setting, a similar approach 
might be useful to mitigate HAND’s impact. However, research in this area is limited and most reports 
have studied only small cohorts, in diverse populations, and the optimal intervention type is unclear 
(Illa et al., 2014; Tedaldi, Minniti, & Fischer, 2015). Psychosocial factors (i.e., social networks, 
spirituality, mood) have been found to be significant predictors of the ability to cope with HAND when 
demographic variables (i.e., gender, age, educational level, and ethnicity) and neurocognitive variables 
(i.e., test scores) are controlled for (Cody et al., 2016). Cognitive remediation therapy training is 
developed to improve cognition in particular domains (like memory or speed or reasoning) or more 
globally (Cody, Fazeli, & Vance, 2015; Vance et al., 2010). The delivery of such training varies widely 
from person training with pen and paper or computer programs to group activities which may also be 
enhanced with exercise and nutritional advice. Cognitive remediation therapy has been found to 
decrease HAND-related stress and anxiety amongst middle-aged and older adults living with HIV 
(Cody, Fazeli, & Vance, 2015; Vance et al., 2010).  
 
 

11 
 
1.2 
Selection of HAND Intervention Model  
 
St. Michael’s Hospital hosts a NeuroAIDS Research Program within their Neurobehavioural Research 
Unit. This program has been in operation for many years, and is the only site for gold standard 
neuropsychological HAND testing in Toronto, Ontario, Canada. People living with HIV who are 
concerned about thinking and memory problems are referred by their physician to this program for 3-
4 hours of neurocognitive evaluation by a clinical neuropsychologist. As this is a research program, 
HAND-diagnosed participants are given the option of consenting to participate in further research.  
 
The ideal HAND intervention model has yet to emerge. Brain training games have shown promise in 
people with HAND, especially in studies from Dr. David Vance at the University of Alabama at 
Birmingham. There are many options for psychosocial group therapy that have been tested in the 
general population with dementia and depression (e.g., Mindfulness-Based Stress Reduction (MBSR), 
Mindfulness-Based Cognitive Therapy (MBCT), and Dialectical Behavior Therapy (DBT)) (Gu, Strauss, 
Bond, & Cavanagh, 2015). These mindfulness interventions have demonstrated promising outcomes 
in reducing stress and anxiety, and improving coping. Although these strategies have not been fully 
tested in HAND, they could have similar benefit. To determine the components of the novel intervention 
in this trial, we interviewed six HAND researchers from the United States, Canada, Spain, and 
Australia. These conversations indicated that: a) initiating brain training software in a group setting 
would be a novel strategy that could improve uptake and use (PositScience by BrainHQ was the 
preferred software); and b) MBSR may be the most suitable group therapy to complement the brain 
training software (see more details below). The combination of brain training games and MBSR fits 
within the category of Cognitive Remediation Group Therapy (CRGT), according to these expert 
informants.  Additionally, we held two focus groups in Toronto – one of community leaders who are 
aging with HIV (n=10) and one of service providers working in the field of HIV (predominantly social 
workers, n=8).These focus groups were held to ascertain the community’s opinion on: a) the ideal 
brain training software out of a short list (i.e., PositScience by BrainHQ,  Lumosity, or Elevate); b) the 
ideal group therapy (i.e., MBSR, MBCT, DBT); b) the logistics of the novel intervention arm (i.e., setting, 
time of day, length of each session); c) a study name brainstorm; and d) the questionnaires’ language 
and ideal method of completion (i.e., in-person with a coordinator, online). Focus group attendees 
agreed with the expert informants that PositScience by BrainHQ was the most compelling option for a 
brain training game, based on personal use experience, existing literature, and the software’s ability 
to be used on all devices (i.e., computer, tablet, phone). The focus groups also identified that weekday 
afternoons may be the ideal time, and that three hours per session (with a break each hour) is a 
suitable length. The method of administering the questionnaires (see section nine) and the study’s title 
(IN HAND) were decided directly from the focus group feedback. 
 
Brain training games from PositScience by BrainHQ have been associated with improved self-report 
in people with MND when focused on specific domains (such as executive functioning or speed-of-
processing), however most work to date has provided this software to individuals in their homes with 
relatively low uptake. Uptake is especially low among those who have more severe cognitive 
impairment. 
 
Mindfulness-Based Stress Reduction (MBSR) is currently being examined in people with MND in a 
trial at the University of California, San Francisco’s Memory and Aging Center (Velcour, in 
communication). This study is showing some promising preliminary feasibility and acceptability. At this 
site, MBSR is delivered in a group therapy format for eight weekly 2-hour sessions. It is facilitated by 
regulated health professionals (i.e., social worker and a nurse) and includes meditation, deep 
breathing, yoga, and talk therapy activities. 
 
Our study will blend brain training with MBSR in a group environment in an attempt to improve uptake 
of the PositScience activities and the emotional coping strategies that can emerge from MBSR. MBSR 
was selected instead of MBCT or DBT as: a) it can delivered in fewer sessions (the current guideline 
for DBT is a minimum 20 sessions); and b) MBSR is focused more on adaptive management as 

12 
 
opposed to the crisis-oriented behavior change that MBCT and DBT seek to impact. In the community 
and provider focus groups, MBSR was favored over the MBCT and DBT options. This combined focus 
on practical and emotional tools could show promise as a feasible, acceptable intervention model that 
can be tested in a larger trial. 
 
1.3 
Study Rationale 
 
There is a need for effective HAND treatment, especially in older adults. A pilot trial is required before 
embarking on a full-scale study for the following reasons: 
 
 
Complexity: HAND is a complex condition that has only begun to be addressed psychosocially in 
controlled settings. We have completed preliminary expert consultation to ensure that: (a) the design 
of the cognitive remediation group therapy (CRGT) aligns with interventions designed from this 
modality in other sites and contexts; (b) to determine how appropriate training will be provided to the 
facilitators of the pilot interventions; and (c) to review the measurement tools to ensure they are the 
best available for this pilot. 
 
Determining Study Participants & Sample Size: Our entry criteria need to be tested in a pilot study 
to ensure feasibility and to determine sample size needed for a full-scale trial. 
 
1.4 
Potential Risks and Benefits to Human Participants 
The proposed research requires participants to attend 10 consecutive weeks of group therapy 
sessions. 
 
Risks 
• Discomfort, anxiety, and/or unease arising from participants disclosing sensitive information 
about themselves to other participants in a group therapy setting. 
• Legal risk regarding the standard limits of confidentiality (i.e., harm to self or other, neglect or 
abuse of a minor, abuse by a regulated health professional). 
 
Benefits 
• Potential to improve coping with HAND 
• Potential for participants to make connections with one another for informal support following 
the therapy session 
• Participants will contribute to a feasibility study that, if successful, would be the basis for a larger 
trial. 
 
2. 
STUDY OBJECTIVES AND DESIGN 
 
2.1 
Overall Study Design 
 
This is a pilot, parallel design, randomized, controlled trial (RCT) that will allocate a sample (n=16) of 
people (≥ 40 yrs old) aging with HIV who have been diagnosed with MND from St. Michael’s Hospital 
(SMH) in Toronto to either arm 1: 10 weekly 3-hour sessions of CRGT; or arm 2: 10 weekly 3-hour 
sessions of HIV group therapy. 
 
2.2 
Primary Objectives 
 
• Determine if a 10-session CRGT is feasible and acceptable to older adults with mild-to-
moderate HAND.  
 

13 
 
Feasibility will be measured based on a sampling frame of approximately 100 people. The following 
targets (all based on a denominator of 100) would need to be met for a larger study to be considered 
feasible: >30% of those contacted agree to participate, >25% complete the Baseline Visit, >20% 
attend the first session, >16% complete the full series and complete the Follow-up Visit. Each 
participant must attend 80% (8/10) of the group sessions to be considered as completing the series. 
Similar targets have been set in other pilot studies of psychosocial interventions (Kazak et al., 2005; 
Ledderer et al., 2013). These targets are also set to ensure that the study feasibly lead to a larger trial, 
as support groups require a minimum four participants per session (Stewart, Usher, & Allenby, 2009). 
There is also a risk to intervention integrity and group cohesion if participants consistently miss multiple 
sessions, usually defined as more than two sessions in a time-limited program (Stewart, Usher, & 
Allenby, 2009). 
 
For acceptability, the number of participants in the sampling frame will be reported. Those who consent 
to participate will be described (i.e., age, gender, ethnicity, length of time living with HIV, length of 
HAND diagnosis, length of time since last HAND follow-up at St. Michael’s Hospital). For those who 
discontinue participation in the study, the research coordinator will follow-up by phone to ascertain the 
reason for attrition and this will be described, if the participant agrees. Participants will complete a 
standardized satisfaction scale (i.e., the Helping Characteristics of Self-Help and Support Groups 
Measure) that will be complemented by questions about session length, number of sessions, activities 
used, and evaluation of facilitators. 
 
2.3 
Secondary Objective 
 
• Determine if a 10-session CRGT can be delivered with fidelity. 
To measure fidelity, facilitators of both study arms will submit weekly session reports. These reports 
will include tick-box lists of the therapy components; use of an average 80% of components listed will 
be considered as good fidelity. These reports will also include open-ended questions about the 
sessions, including questions on group dynamics, challenges faced, and detail on activities used. 
Qualitative reports from each arm will be analyzed by coders familiar with the intervention models. 
 
2.4 
Exploratory Objectives 
 
• To evaluate the change in stress, anxiety, and coping. 
• Sustained use of brain training activities 
• Change in use of mindfulness strategies  
 
3. 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
 
3.1 
Number of Participants 
 
A total of 16 participants (8 in each study arm) will be enrolled. 
 
3.2 
Inclusion Criteria 
 
1. Male or female; aged ≥ 40 years 
2. Documented HAND diagnosis of Mild Neurocognitive Disorder (MND) 
3. ≥ 5 years of HIV infection  
4. Provided consent to St. Michael’s Hospital to be contacted for future research studies 
5. Can feasibly attend 10 weeks of group therapy in downtown Toronto 

14 
 
3.3 
Exclusion Criteria 
 
1. Diagnosis of another significant psychiatric diagnosis (i.e., schizophrenia, bipolar disorder, 
etc.) and/or past traumatic brain injury 
2. Documented HAND diagnosis of asymptomatic neurocognitive impairment (ANI) or HIV-
associated dementia (HAD) 
3. Active intravenous or crystal meth drug use 
4. Hospitalization within past 1 month 
5. Inability to communicate in English 
6. Inability to use a tablet 
 
3.4 
Concomitant Alcohol and “Street” Drug Use 
 
Active intravenous drugs and/or crystal meth drug use will exclude potential participants from the study. 
Drug use will not be actively tested during the study period, however both arms will establish and 
maintain a 24-hour sobriety norm. Participants may be asked to leave a group session if their 
substance impairment is negatively effecting the group experience for other participants. 
 
3.5 
Recruitment and Enrollment Procedures 
 
A list of participants who appear to meet entry criteria (based on their last clinic visit) will be provided 
to the research coordinator by the St. Michael’s Hospital Neurobehavioral Research Unit. The research 
coordinator will sequentially contact participants by phone during a Screening Call, starting with those 
who accessed the clinic most recently. The study and entry criteria will be briefly described by phone 
and, if the prospective participant is interested, a Screening Visit will be scheduled between the 
potential participant and the research coordinator. The Screening Visit will involve the research 
coordinator meeting with the participant to discuss the study and review the informed consent form; if 
the participant does not consent, the visit will end. If the participant is interested but requests more 
time to look over the informed consent form with family, friends, or their family doctor, an alternative 
Screening  Visit date can be scheduled. If the potential participant immediately consents to participate 
in the research study, the research coordinator will obtain the participant’s preferred schedule to attend 
a 10-week group (i.e., afternoons, evenings), and will then discern the participant’s access to a mobile 
device (i.e., smartphone or tablet). If a prospective participant does not have a mobile device that the 
PositScience software could be used on, a mobile device will be provided to the participant for the 
course of the study (returned at the follow-up visit). Participants will also be asked to self-report any 
changes that they have noticed in their cognition since their last clinic visit. The consent form will 
include a section allowing the research coordinator to conduct a chart review, to collect demographic 
information, health history and medication use to confirm eligibility. Once eligibility has been confirmed, 
participants will be contacted by the research coordinator to schedule a Baseline Visit. Baseline Visits 
will be held within the same week, to control for a potential time effect. At the conclusion of the Baseline 
Visit, the participant will be randomized into one of the two study arms. Participants will have a 
preliminary meeting with the therapy facilitators to acquaint themselves to the upcoming group prior to 
the first session. This meeting is described in a section 9.3.2. 
 
3.6 
Co-enrollment guidelines 
 
Co-enrollment in another HAND or mindfulness treatment study is not permitted. 
 
3.7 
Sampling and Recruitment 
 
There are approximately 100 people currently in the sampling frame (see Appendix V). This should 
provide an adequate frame to recruit participants (n = 16), especially as there is little other treatment 

15 
 
available for HAND in Toronto (or elsewhere). We will initiate the trial with a minimum of 75% 
participant enrolment (n = 12, with n = 6 in the Experimental arm and n = 6 in the Active Control arm) 
if required. 
 
4. 
WITHDRAWAL OF PARTICIPANTS 
 
4.1 
Withdrawal criteria 
 
Investigators may withdraw a participant from the study in the event that:  
• 
a new health condition appears that is suspected to require care or medications prohibited by the 
protocol 
• 
it is in the participant’s best interest according to an Investigator’s clinical judgment 
• 
a participant misses two consecutive sessions 
• 
a participant’s substance use has become a hindrance to the experience of other participants 
 
Participants may cancel their participation in the study at any time. When participants cancel, they will 
be asked if they consent to provide a reason for their withdrawal. Participants will not be replaced in 
this study once the group therapies commence, as replacement could negatively impact group 
dynamics. 
 
4.2 
Procedures for Discontinuation 
 
If a participant withdraws or is removed from the study for any reason prior to the completion of the 
study, the reason will be recorded on the appropriate case report form (CRF). 
 
5. 
RANDOMIZATION PROCEDURE 
 
5.1 
Randomization 
 
Once enrollment is complete and all participants have consented to take part in the study and been 
screened for entry criteria, and attended the Screening Visit and Baseline Visit, the research 
coordinator will contact the CTN to request randomization  assignments. Participants will be randomly 
assigned to one of the two study arms (Arm 1 = Experimental or Arm 2 = Active Control) using random 
numbers in blocks of size two. Randomization will be performed in a 1:1 fashion to allow for equal 
numbers of participants in both arms. 
6. 
THERAPY OVERVIEW 
  
 
6.1 
Arm 1: Experimental Therapy 
 
CRGT will be comprised of 10 weekly 3-hour sessions held at Toronto General Hospital and facilitated 
by an MBSR-certified social worker and a peer (i.e., person aging with HIV). The peer will lead 
facilitation of the brain training exercise, which will comprise 1/3 of each group session. The brain 
training exercise will be delivered on tablets using PositScience software by BrainHQ.This software 
will be downloaded to participants’ mobile device (phone or tablet). If a participant does not have a 
mobile device, a tablet will be provided. This software tailors the participant experience based on deficit 
domains. Participants will work through activities and support one another through their various 
strengths and weaknesses. The MBSR-certified practitioner will lead facilitation of the MBSR 

16 
 
component, which will comprise the remaining 2/3 of each group session. MBSR involves various 
activities such as meditation, breathing exercises, etc. to achieve emotional regulation. 
 
6.2 
Arm 2: Active Control  
 
The active control group will be comprised of 10 weekly 3-hour sessions of a Living with HIV Support 
Group held at the AIDS Committee of Toronto (ACT). This support group will be facilitated by a certified 
social worker and a peer (i.e., person aging with HIV). These groups use a model of mutual aid to 
encourage peer-based discussion on the effects of living with HIV. Topics are determined by the group; 
facilitators ensure that safety is maintained throughout and make connections between participants as 
appropriate. This model is the standard of group therapy for people with dementia (Toms, Clare, Nixon, 
& Quinn, 2015) and is also frequently used for people living with HIV community-based service 
organizations in Ontario. 
 
 
7. 
RISKS AND PRECAUTIONS 
7.1 
Risk Management 
 
There is potential for research participants/group members to expose sensitive information about the 
group and/or other group members. Research participants/group members will be asked during the 
consent process and throughout the group sessions to maintain the confidentiality of the group, 
however group members are not bound by professional obligations to maintain the confidentiality of 
the group. Facilitators are bound by professional obligations to maintain the confidentiality of the group. 
The potential exposure of sensitive information will be highlighted in the consent form, and research 
participants/group members will be advised to practice some caution before sharing personal and 
sensitive information. Participants will only be referred to by a first name, and will be offered the 
possibility of using a pseudonym in group. 
 
Research participants/group members may also experience discomfort and/or unease with discussion 
topics that emerge in the group context. Throughout the group sessions, the co-facilitators will debrief 
with research participants/group members and offer them opportunities to discuss any discomfort one-
on-one. Research participants/group members will also be provided with information related to other 
counselling and support services available to them. 
 
In terms of legal risk, participants will be informed of the standard limits of confidentiality during the 
consent process (harm to self or other, neglect or abuse of a minor, abuse by a regulated health 
professional). Co-facilitators will follow all legal requirements, in adherence with the policies set out by 
the agencies participating in this project.   
 
7.2 
Mental Health Support 
 
A list with crisis centres, counselling options, and emergency supports will be provided to participants. 
Participants will also be informed that they are welcome to avail themselves of free, confidential 
counselling at the AIDS Committee of Toronto (ACT) by a counsellor unrelated to the study team. 
 
8. 
CLINICAL EVALUATIONS 
8.1 
Questionnaires 
 
For all questionnaires, the coordinator will be provided with a script so that they do not bias the 
answers. Baseline, Follow-Up, and End of Study questionnaires (as identified in Table 1) will be 
completed on a tablet or computer, unless the participant prefers a paper version, with the research 
coordinator assisting the participant with understanding questions and selecting responses. The group 

17 
 
satisfaction questionnaire in sessions 5 & 10 will be completed on paper. This questionnaire will contain 
the scale identified in Table 1, and will be complemented by questions regarding satisfaction with 
session, length, content, and feedback on the facilitators. 
 
The stress, anxiety, mindfulness, and coping questionnaires will be completed electronically on a tablet 
or computer by the participant with the research coordinator’s assistance at baseline, post-therapy, 
and 3-month follow-up. These questionnaires can be completed on paper and entered into the 
database by the research coordinator if requested by the participants 
 
The Helping Characteristics of Self-Help and Support Groups Measure will be completed on paper by 
participants in the fifth and in the final session of their group therapy. 
 
• Appendix I:  
o HIV/AIDS Stress Scale (29 items, Likert, α = 0.76-0.85) (Packenham & Rinaldis, 2002). 
• Appendix II:  
o Anxiety in Cognitive Impairment and Dementia (Gerolimatos et al., 2015) 
• Appendix III:  
o Helping Characteristics of Self-Help and Support Groups Measure (20 items, Likert, α = 
0.79-0.87) 
• Appendix IV:  
o Five Facet Mindfulness Questionnaire – Short Form (FFMQ-SF) (24 items, Likert, α = 
0.73-0.91) 
• Appendix V:  
o Coping Self-Efficacy Scale of Health Problems (10 items, Likert, α = 0.779) (Gandoy-
Crego et al., 2016) 
 
9. 
STUDY PROCEDURES 
 
9.1 
Schedule of Events 
 
Table 1: Schedule of Events 
  
Study Period 
Screening Period 
Study Period 
(Facilitator meeting & 10 weekly, 3-hour 
sessions) 
Follow-up Period 
Visit Name 
Screening 
Call 
Screening 
Visit 
Baseline 
Visit 
Facilitator 
meeting 
Sessions 1-9 
Sessions 
5 & 10 
Follow-
up Visit 
End of 
Study Visit 
(3 Month 
Follow-up) 
Visit No. 
-3 
-2 
-1 
0 
1,2,3,4,6,7,8,9 
5 & 10 
11 
12 
Week No. 
 
 
-1 
1-10 
11 
23 
Day No. 
-56 to -7 days 
-7 
1-70 
77 
167 
Visit Window 
+/- 7 
+/- 7 
+/- 7 
+/- 7 
+/- 0 
+/- 0 
+/- 7  
+/- 7 
Procedures: 
 
 
 
 
 
 
Written 
Informed 
Consent  
 
X 
 
 
 
 
 
 
Entry Criteria 
Assessment 
X 
X 
 
 
 
 
 
 
Chart 
abstraction 
 
X 
 
 
 
 
 
 

18 
 
(demographics, 
medical history, 
medications)  
Randomization  
 
 
X2 
 
 
 
 
 
Group Session 
(CRGT or 
Control) 
 
 
 
X3 
X 
X 
 
 
Weekly 
Session 
Report1 
 
 
 
 
X 
X 
 
 
Helping 
Characteristics 
of Self-Help 
and Support 
Groups 
Measure 
Questionnaire 
 
 
 
 
 
X 
 
 
HIV/AIDS 
Stress Scale 
 
 
X 
 
 
 
X 
X 
Anxiety in 
Cognitive 
Impairment and 
Dementia 
Scale 
 
 
X 
 
 
 
X 
X 
Coping Self-
efficacy of 
Health 
Problems 
Scale 
 
 
X 
 
 
 
X 
X 
Five Facet 
Mindfulness 
Questionnaire 
– Short Form 
(FFMQ-SF) 
 
 
X 
 
 
 
X 
X 
 
1 Completed by therapy facilitator 
2 To occur once all participants have been enrolled and eligibility confirmed 
3 Acquaintance with group only; no therapy will be administered during this session 
 
9.2 
Screening Period Procedures/Assessments 
 
9.2.1 
Screening Call [Visit no. -3] 
 
The research coordinator will phone the participant to: 
• Describe the study 
• Review entry criteria 
• Schedule a time to meet for the Screening Visit 
 
It is expected that this call will be approximately twenty (20) minutes. 
 
9.2.2 
Screening Visit [Visit no. -2] 
 
The following activities will occur at the Screening Visit: 
• The Informed Consent Form will be reviewed with the participant 
• The participant will be asked to sign the consent form 

19 
 
• The participant’s availability to participate in a 10-session group will be ascertained (e.g., 
preference for afternoons, time of day) 
• The participant’s ability to access a mobile device (i.e., smartphone or tablet) will be determined 
It is expected that this visit will be approximately thirty (30) minutes. 
 
After the Screening Visit and if the participant has signed in the Informed Consent Form, the research 
coordinator will conduct a chart review to abstract demographics, medical history, and medications. 
This chart abstraction will confirm entry criteria. 
 
9.2.3 
Baseline Visit [Visit no. -1] 
 
The following activities will occur at the Baseline Visit: 
• The participant will be asked to complete the following study questionnaires: 
o HIV/AIDS Stress Scale 
o Anxiety in Cognitive Impairment and Dementia Scale 
o Coping Self-efficacy of Health Problems Scale 
o Five Facet Mindfulness Questionnaire – Short Form 
o Two brief questions on use of brain training activities 
The Baseline Visit will take approximately thirty (30) minutes to complete. 
 
9.3 
Study Period Procedures/Assessments  
 
9.3.1 
Study Arms  
 
Arm 1 (Experimental Therapy): CRGT will be facilitated by an MBSR-certified social worker and a 
peer (i.e., person aging with HIV). The peer will lead facilitation of the brain training exercise, which 
will comprise one-third of each group session. Brain training exercises will be delivered on tablets using 
PositScience software by BrainHQ. This software tailors participant experience based on deficit 
domains. Participants will work through activities and support one another through their strengths and 
weaknesses. The social worker will lead facilitation of the MBSR component, which will comprise the 
remaining time of each session. MBSR involves activities such as meditation and breathing exercises 
to achieve emotional regulation. 
 
Arm 2 (Active Control): The active control group will be facilitated by a social worker and a peer. 
These groups use a model of mutual aid to encourage peer-based discussion on the effects of living 
with HIV. Topics are determined by the group; facilitators ensure that safety is maintained throughout 
and make connections between participants as appropriate. 
 
9.3.2 
Facilitator Meeting [Visit no. 0] 
 
The Facilitator meeting in both study arms will include a preliminary meeting with the experimental 
therapy and active control facilitators to acquaint themselves to the upcoming group prior to the first 
session. This will take approximately 20 minutes and will take place at the therapy site (arm 1 
(Experimental): Toronto General Hospital; arm 2 (Active Control): ACT). 
 
9.3.3 Therapy Sessions 1, 2, 3, 4, 5, 6, 7, 8, 9 & 10 [Visit no. 1, 2, 3, 4, 5, 6, 7, 8, 9, & 10] 
 
During these visits all participants will attend the three-hour sessions as described above during ten 
consecutive weeks. 
 
After each visit, the therapy facilitator will complete a weekly session report. 

20 
 
 
At the conclusion of visits 5 & 10, the following activity will occur: 
• Participants will be asked to complete the “Helping Characteristics of Self-Help and Support 
Groups Measures” questionnaire. 
This questionnaire will take approximately ten minutes to complete. 
 
 
9.4 
Follow-up Period Procedures/Assessments 
 
9.4.1 Follow-up Visit [Visit no. 11] 
 
The participant will be asked to complete the following study questionnaires: 
o HIV/AIDS Stress Scale 
o Anxiety in Cognitive Impairment and Dementia Scale 
o Coping Self-efficacy of Health Problems Scale 
o Five Facet Mindfulness Questionnaire – Short Form 
o Two brief questions on use of brain training activities 
 
This visit will take approximately thirty (30) minutes to complete. 
 
9.5 
End of Study Visit [Visit no. 12] 
 
The participant will be asked to complete the following study questionnaires: 
o HIV/AIDS Stress Scale 
o Anxiety in Cognitive Impairment and Dementia Scale 
o Coping Self-efficacy of Health Problems Scale 
o Five Facet Mindfulness Questionnaire – Short Form 
o Two brief questions on use of brain training activities 
 
This visit will take approximately thirty (30) minutes to complete. 
 
 
9.6 
Early Termination 
 
If a participant cancels participation in the study, the research coordinator will attempt to follow-up with 
them to determine the reason for cancellation. These reasons will be described to inform the feasibility 
and acceptability outcomes. 
 
10. STATISTICAL CONSIDERATIONS 
 
 
10.1 
General Study Design 
 
This study is primarily focused on feasibility, acceptability, and intervention fidelity. Feasibility and 
acceptability will be analyzed using descriptive statistics (# of attendees, % satisfaction, etc.). 
Intervention fidelity will be analyzed qualitatively regarding how closely the facilitators adhered to their 
intervention model. 
 
 

21 
 
10.2 
Sample Size Considerations/Justification  
 
A sample size of 16 participants (8 in each study arm) has been selected as: (a) 8 participants has 
been found to be an ideal size for a 10-week group therapy intervention (Stewart, Usher, & Allenby, 
2009; Erickson, 1982; Weis, 2003); and (b) this number will provide preliminary insight into the 
acceptability of novel CRGT arm, which will be important to consider before the larger RCT is initiated. 
This sample size has also been selected for feasibility: 16 qualifying participants can be feasibly 
enrolled in the pilot given the number of qualifying participants available for sampling from the patients 
tested for HAND at St. Michael’s Hospital Neurobehavioral Research Centre (N=~100). It is expected 
that this sample can be enrolled in a 2-month period. 
 
10.2.1 
Efficacy: Intent-to-Treat 
 
The intent-to-treat (ITT) data set will include data from all randomized participants. All data will be 
included and no participants excluded because of protocol deviations. The proportion of patients who 
consented to participate and who actually participated will be described against the total number of 
patients contacted. 
 
10.3 
Analysis of Demographic and Baseline Data 
 
Demographics will be described, to provide characteristics (i.e., gender, age, ethnicity, sexual 
orientation) of participants in this pilot study.  
 
10.4 
Analysis of Primary Outcome Measures 
 
 
Feasibility and acceptability results will be reported against the targets specified in Section 2.2 of this 
protocol. 
 
10.5 
Analysis of Secondary Outcome Measures  
 
 
The sample size severely limits any statistical procedures for analyzing change in stress, anxiety, and 
coping. Depending on the nature of the results (and the true sample size), non-parametric tests or a 
power analysis may be appropriate. 
 
10.6 
Other Analytical Issues / Considerations 
 
Loss to follow-up rates are important to consider for the feasibility of a larger trial. The research 
coordinator will attempt to contact a participant on three separate days to schedule follow-up visits. A 
participant will be welcome to attend the Follow-Up and End-of-Study visits within +/- 2 weeks of the 
actual visit date. 
 
11. STUDY ETHICAL CONSIDERATIONS 
 
 
11.1 
Ethical Conduct of the study 
 
This study will be conducted in accordance with the ICH GCP Guidelines, the Tri-Council Policy 
Statement Version 2 (TCPS2) and the principles in the Declaration of Helsinki.  
 
11.2 
Informed Consent 
 
 
All participants will be given detailed oral and written information about the study. Consent forms 
describing in detail the study procedures and risks will be given to each participant and written 
documentation of informed consent is required prior to starting any study procedures. Participants 

22 
 
must sign an informed consent document that has been approved by a participating centre’s REB/IRB 
prior to any procedures being done specifically for the trial.  Each participant should have sufficient 
opportunity to discuss the study, have all of their questions addressed and consider the information in 
the consent process prior to agreeing to participate.  Participants may withdraw consent at any time 
during the course of the study without prejudice. The informed consent form will be signed and dated 
by the participant and the study coordinator. The original signed informed consent form will be retained 
in the participant’s study files and a copy will be provided to the participant. 
 
The informed consent form must be signed before the participant undergoes any screening procedures 
that are performed solely for the purpose of determining eligibility for the study. 
 
11.3 
Confidentiality 
 
All participant-related information including Case Report Forms, evaluation forms, reports, etc. will be 
kept strictly confidential.  All records will be kept in a secure, locked location and only accessible to 
research staff.  Participants will be identified only by means of a coded number specific to each 
participant . All computerized databases will identify participants by numeric codes only, and will be 
password protected. 
 
Upon request, and in the presence of the investigator or his/her representative, participant records will 
be made available to the study sponsor, monitoring groups representative of the study sponsor, 
representatives of funding groups, and applicable regulatory agencies for the purpose of verification 
of clinical trial procedures and/or data, as is permissible by local regulations. 
 
11.4 
Institutional Review Board, Ethics Committee, or Research Ethics Board 
 
A copy of the protocol (including protocol amendments), all versions of informed consent forms, other 
information to be completed by participants such as survey instruments or questionnaires, and any 
proposed advertising/ recruitment materials must be reviewed and approved by the REB/IRB of each 
participating centre prior to implementation of the trial.  The site investigator will be responsible for 
obtaining REB/IRB approval of the annual Continuing Review throughout the duration of the study.   
 
12. General Trial Conduct Considerations 
 
12.1 
Adherence to Protocol 
 
 
12.1.1 
Protocol Deviations  
 
No deviations from this protocol will be permitted without the prior written approval of the Sponsor, 
except when the modification is needed to eliminate an immediate hazard or hazards to participants. 
Any deviations that may affect a participant’s treatment or informed consent, especially those 
increasing potential risks, must receive prior approval from the REB unless performed to remove an 
immediate safety risk to the participants. In this case it will be reported to the REB and the Sponsor 
immediately thereafter. Any departures from the protocol must be documented. 
 
12.2 
Record Keeping 
 
12.2.1 
Data Collection 
 
All data will be entered electronically into a password-protected study database that will be accessible 
by the study team and the CTN. All paper documents will be stored in a locked filing cabinet in the 

23 
 
office of Andrew Eaton at the AIDS Committee of Toronto (ACT) for a period of seven years, at which 
point they will be destroyed. 
 
12.2.2 
Data Corrections 
 
Corrections of data entered on source documents must be made in the following manner: 
• The original response crossed out and the new response indicated in blueink. The change will 
be initialed and dated by the person making the correction. 
 
12.2.3 
Source Documents 
 
The Investigator must maintain adequate and accurate source documents upon which CRFs for each 
participant are based. They are to be separate and distinct from CRFs except for cases in which the 
Investigator has pre-determined that direct data entry into specified pages of the participant’s CRF is 
appropriate. These records should include detailed notes on: 
• Oral and written communication with participant regarding the study therapy (risks/benefits) 
• Participation in trial and signed and dated informed consent forms  
• Inclusion and exclusion criteria details  
• Visit dates  
• Reason for premature discontinuation (if applicable) 
• Enrollment number 
• Compliance/noncompliance protocol deviation information 
 
12.2.4 
Data Management 
 
Instructions concerning the recording of study data on CRFs will be provided by the CTN Data 
Management Centre. Each study site is responsible for submitting the data in a timely fashion.  
 
Detailed aspects of data handling will be described in the Data Management Plan. 
 
12.2.5 
Record Retention 
 
The Investigator will maintain all study records according to the ICH-GCP and REB/IRB requirements. 
Records will be retained for 7 years. If the Investigator withdraws from the responsibility of keeping the 
study records, custody must be transferred to a person willing to accept the responsibility and the 
Sponsor notified. The Investigator should ensure that no destruction of medical records occurs without 
the written approval of the Sponsor. 
 
13. Disclosure and publication Policy 
 
 
We plan to publish three academic papers based off this study: a) pilot trial protocol; b) feasibility and 
acceptability results; and c) a CRGT intervention fidelity paper. 
 
 

24 
 
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Stewart, L., Usher, A., & Allenby, K. “A Review of Optimal Group Size and Modularisation or 
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Canada (2009). http://www.csc-scc.gc.ca/005/008/092/005008-0215-01-eng.pdf  
 
Tedaldi, E., Minniti, N., & Fischer, T. “HIV-Associated Neurocognitive Disorders: The Relationship of 
HIV Infection with Physical and Social Comorbidities.” BioMed Research International 2015.641913 
(2015): 1-13. 
 
Thorn, B., & Kuhajda, M. “Group Cognitive Therapy for Chronic Pain.” Journal of Clinical Psychology 
62.11 (2006): 1355-1366. 
 
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doi:10.1017/S1041610215000691 

26 
 
 
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27 
 
APPENDICES 
Appendix I - HIV/AIDS Stress Scale 
Below is a list of problems that people living with HIV sometimes have. For each question, there are two 
examples to describe the problem. Your own examples may differ from the ones provided, so long as they seem 
to fit within the problem category. Please circle a number to the right of each question that best describes how 
troublesome that problem has been for you during the past month. 
 
How much were you troubled by: 
Not at 
all 
A bit 
(once 
or 
twice 
in the 
past 
month) 
Moderat
e (once 
or twice 
a week 
for the 
past 
month) 
A lot 
(three 
to six 
times a 
week 
for the 
past 
month) 
Extreme 
(daily) 
1. Distressing emotions related to HIV 
(e.g., you feel angry or fearful; you feel 
anxious or depressed) 
0 
1 
2 
3 
4 
2. Relationship difficulties related to HIV 
(e.g., you have arguments with your support 
person about how to best care for your 
health; you have difficulty establishing a 
relationship) 
0 
1 
2 
3 
4 
3. Grief/bereavement related to HIV (e.g., 
you are concerned about your own losses 
such as loss of independence; you are 
grieving for the loss of a loved one from 
AIDS) 
0 
1 
2 
3 
4 
4. 
Confidentiality/privacy 
concerns 
related to HIV (e.g., you are concerned 
about your HIV status breached; you are 
reluctant to disclose your status to others) 
0 
1 
2 
3 
4 
5. Sexual difficulties related to HIV (e.g., 
you’re finding it hard to maintain safe sex 
behaviours; you are sexually frustrated) 
0 
1 
2 
3 
4 
6. Difficulties in coming to terms with your 
HIV status 
(e.g., you can’t accept that you have HIV; 
you refuse to even think about HIV) 
0 
1 
2 
3 
4 
7. Concerns about death related to HIV 
(e.g., you are preoccupied with dying; you 
don’t think about the possibility that you may 
die from HIV) 
0 
1 
2 
3 
4 
8. Isolation related to HIV (e.g., you have 
less contact with others because of HIV; you 
don’t get invited out much now that you have 
HIV) 
0 
1 
2 
3 
4 
9. Suicidal thoughts/attempts related to 
HIV (e.g., you have thoughts of ending your 
life; you have actually attempted to end your 
life) 
0 
1 
2 
3 
4 

28 
 
10. Increased drug/alcohol intake related 
to HIV (e.g., you use drugs and/or alcohol 
more now; you are often high or drunk) 
0 
1 
2 
3 
4 
11. 
Discrimination/stigma 
concerns 
related to HIV (e.g., you are concerned that 
you will be discriminated against because of 
HIV; you feel as if you have not been treated 
with respect) 
0 
1 
2 
3 
4 
12. 
Religious/existential 
difficulties 
related to HIV (e.g., you are having 
difficulty searching for meaning in your life; 
you are struggling to make sense of the 
predicament you are in) 
0 
1 
2 
3 
4 
13. Overly attentive to bodily functions or 
changes (e.g., you are constantly checking 
for HIV-related symptoms; you are overly 
attentive to any new physical changes such 
as appearance of a rash) 
0 
1 
2 
3 
4 
14. Difficulties in telling others of your 
HIV status (e.g., you don’t know who, how, 
or when to tell of your HIV status; you have 
only told one or two people) 
0 
1 
2 
3 
4 
15. Boredom related to HIV (e.g., you are 
unable to use your free time doing things you 
would normally enjoy; you often find 
yourself sitting about doing nothing) 
0 
1 
2 
3 
4 
16. Difficulty dealing with HIV-related 
symptoms of illness (e.g., you often have 
difficulty dealing with fatigue or nausea; you 
have pain and physical discomfort most of 
the time) 
0 
1 
2 
3 
4 
17. Difficulty in enhancing your health 
(e.g., your attempts to maintain adequate 
nutrition, or a positive mental attitude often 
are short-lived) 
0 
1 
2 
3 
4 
18. Difficulty with health care system (e.g., 
you have difficulties in getting access to 
health services such as dentists or home care) 
0 
1 
2 
3 
4 
19. Difficulties with HIV treatment (e.g., 
you have difficulties managing side effects 
from HIV treatments; you can’t adhere to 
HIV treatment) 
0 
1 
2 
3 
4 
20. Transport difficulties related to HIV 
(e.g., you have difficulty getting appropriate 
transport to places; public transport is 
physically demanding) 
0 
1 
2 
3 
4 
21. Financial difficulties related to HIV 
(e.g., you are unable to pay debts; you have 
problems with superannuation payouts) 
0 
1 
2 
3 
4 
22. Daily living difficulties related to HIV 
(e.g., you can’t always do the shopping or 
cleaning; you can’t keep up with the basic 
day-to-day chores) 
0 
1 
2 
3 
4 

29 
 
23. Reducing risk of infection (e.g., you are 
preoccupied 
with 
thoughts 
about 
transmitting HIV to others; you can 
concerned that some of your behaviours may 
put others at risk) 
0 
1 
2 
3 
4 
24. Difficulty in accessing information 
related to HIV (e.g., you have received 
conflicting information on HIV; you can’t 
get adequate treatment information) 
0 
1 
2 
3 
4 
25. Employment difficulties related to 
HIV (e.g., 
you can’t obtain/maintain 
employment because of illness; you are 
concerned about work-related stress) 
0 
1 
2 
3 
4 
26. Legal problems related to HIV (e.g., 
you are involved in a legal process; you don’t 
know who to assign power of attorney to) 
0 
1 
2 
3 
4 
27. Planning difficulties related to HIV 
(e.g., uncertaint with your health makes 
career planning difficult; you don’t know 
whether to start new projects) 
0 
1 
2 
3 
4 
28. Difficulties with thinking processes 
related to HIV (e.g., you forget things more 
than usual; you can’t concentrate as well as 
usual) 
0 
1 
2 
3 
4 
29. Dealing with declining health related 
to HIV (e.g., you have difficulty in dealing 
with increasing physical restrictions due to 
declining health; you have difficulty dealing 
with the change from being well to having 
illness) 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 
 

30 
 
Appendix II - Anxiety in Cognitive Impairment and Dementia Scale 
 
Please circle yes or no for the following questions, thinking about the past 24 hours. If you answer yes to the 
numbered questions, please answer the corresponding letter question below it. 
 
In the past 24 hours: 
 
1. Have you experienced worry? 
 
 
 
Yes 
 
No 
 
(e.g., about health, memory of cognitive functioning, friends and family, etc.) 
 
a. If so, did worrying bother you? 
 
 
Yes 
 
No 
 
2. Have you experienced anxiety? 
 
 
 
Yes 
 
No 
 
(e.g., about health, memory of cognitive functioning, friends and family, etc.) 
 
a. If so, did the anxiety bother you? 
 
 
Yes 
 
No 
 
3. Have you been startled? 
 
 
 
 
Yes 
 
No 
 
(e.g., sudden scare, no sense of time and place, etc.) 
 
a. If so, did the startle bother you? 
 
 
Yes 
 
No 
 
4. Have you experienced insomnia? 
 
 
 
Yes 
 
No 
 
(e.g., sleeplessness, etc.) 
 
a. If so, did the insomnia bother you?  
 
Yes 
 
No 
 
5. Have you experienced irritability? 
 
 
 
Yes 
 
No 
 
(e.g., low patience, expression of frustration, etc.) 
 
a. If so, did the irritability bother you?  
 
Yes 
 
No 
 
6. Have you experienced muscle tension? 
 
 
Yes 
 
No 
 
a. If so, did the muscle tension bother you? 
 
Yes 
 
No 
 
7. Have you experienced restlessness?  
 
 
Yes 
 
No 
 
(e.g., fidgeting, etc.) 
 
a. If so, did the fidgeting bother you? 
 
 
Yes 
 
No 
 
8. Have you experienced fatigue? 
 
 
 
Yes 
 
No 
 
(e.g., overly tired, not as much energy as normal etc.) 
 
a. If so, did the fatigue bother you? 
 
 
Yes 
 
No 
 
9. Have you experienced cardiovascular issues? 
 
Yes 
 
No 
 
(e.g., chest pain, etc.) 
 
a. If so, did the cardiovascular issues bother you? 
Yes 
 
No 
 
10. Have you experienced respiratory issues? 
 
 
Yes 
 
No 
 
(e.g., shortness of breath, etc.) 
 

31 
 
a. If so, did the respiratory issues bother you?  
Yes 
 
No 
 
11. Have you experienced gastrointestinal issues? 
 
Yes 
 
No 
 
(e.g., diarrhea, excessive flatulence, etc.) 
 
a. If so, did the gastrointestinal issues bother you? 
Yes 
 
No 
 
12. Have you experienced other somatic issues?  
 
Yes 
 
No 
 
(e.g., pain, depression, etc.) 
 
a. If so, did the somatic issues bother you? 
 
Yes 
 
No 
 
13. Have you experienced any avoidance behaviours?  
Yes 
 
No 
 
(e.g., denial, not wanting to attend appointments, etc.) 
 
a. If so, did the avoidance behaviour bother you? 
Yes 
 
No 
 
 
 
 
 
 

32 
 
Appendix III - Helping Characteristics of Self-Help and Support Groups Measure 
doi: http://dx.doi.org/10.1037/t46411-000 
Factor 1: Instilling Hope and Sense of Control 
1. 
Since I started coming to meetings, I have begun to have more faith in my ability to change 
myself.a 
2. 
Since I started coming to meetings, I have begun to cope much better with my life. 
3. 
The group helps me find new coping strategies. 
4. 
The group has helped me learn ways of solving my problems.b 
5. 
The group has helped me find ways of controlling myself. 
Factor 2: Alternative to Loneliness and Professional Intervention 
6. 
The group makes me feel I’m not alone with my difficulties. 
7. 
The group takes me out of my loneliness. 
8. 
A professional could never understand me the way group members can. 
9. 
The group helps me evaluate my coping strategies. 
10. 
The group makes me feel I can function as well as anyone else. 
11. 
Other group members’ knowledge and experience helps me as much as the help I could get from 
professionals. 
Factor 3: Emotional Disclosure and Catharsis 
12. 
I share my life experiences with other members of the group. 
13. 
I share my troubles with other members of the group. 
14. 
Members of the group disclose personal and intimate details of their lives. 
15. 
The group helps me to release tension. 
Factor 4: Members’ Experiential Knowledge 
16. 
I contribute my own knowledge and experience to the other members. 
17. 
I help the members of the group a lot through my own knowledge and experience. 
18. 
The knowledge and experience I acquired as a result of my situation contribute to the group at 
least the same as the knowledge of a professional. 
Factor 5: Caring and Concern 
19. 
When something bothers me, members of the group treat me kindly. 
20. 
Group members care about each other. 
Factor 6: Coping Methods (“tips”) 
21. 
I give group members “tips” on how to cope with daily situations. 
22. 
The group offers me “tips” on how to cope with daily situations. 
Note . a. The range for items 1 to 3, 5, 9, 16, 21, and 22 after reversing the scale is 1 = never to 5 = always. 
b. The range for items 4, 6 to 8, 10 to 15, and 17 to 20 is 1 = certainly wrong to 6 = certainly right. 
 
 

33 
 
Appendix IV – Five Facet Mindfulness Questionnaire – Short Form  (FFMQ-SF) 
Below is a collection of statements about your everyday experience. Using the 1–5 scale below, please indicate, 
in the box to the right of each statement, how frequently or infrequently you have had each experience in the 
last month (or other agreed time period). Please answer according to what really reflects your experience rather 
than what you think your experience should be. 
 
never or 
not often 
sometimes true 
often 
very often 
very rarely true 
true 
sometimes not true 
true 
or always true 
1 
2 
3 
4 
5 
 
1 
I’m good at finding the words to describe my feelings 
DS 
2 
I can easily put my beliefs, opinions, and expectations into words 
DS 
3 
I watch my feelings without getting carried away by them 
NR 
4 
I tell myself that I shouldn’t be feeling the way I’m feeling 
/NJ 
5 
it’s hard for me to find the words to describe what I’m thinking 
/DS 
6 
I pay attention to physical experiences, 
such as the wind in my hair or sun on my face 
OB 
7 
I make judgments about whether my thoughts are good or bad. 
/NJ 
8 
I find it difficult to stay focused on what’s happening in the present moment 
/AA 
9 
when I have distressing thoughts or images, 
I don’t let myself be carried away by them 
NR 
10 generally, I pay attention to sounds, such as clocks ticking, 
birds chirping, or cars passing 
OB 
11 when I feel something in my body, it’s hard 
for me to find the right words to describe it 
/DS 
12 it seems I am “running on automatic” 
without much awareness of what I’m doing 
/AA 
13 when I have distressing thoughts or images, I feel calm soon after 
NR 
14 I tell myself I shouldn’t be thinking the way I’m thinking 
/NJ 
15 I notice the smells and aromas of things 
OB 
16 even when I’m feeling terribly upset, I can find a way to put it into words 
DS 
17 I rush through activities without being really attentive to them 
/AA 
18 usually when I have distressing thoughts or 
images I can just notice them without reacting 
NR 

 
 
 
never or 
not often 
sometimes true 
often 
very often 
very rarely true 
true 
sometimes not true 
true 
or always true 
1 
2 
3 
4 
5 
 
19 I think some of my emotions are bad 
or inappropriate and I shouldn’t feel them 
/NJ 
20 I notice visual elements in art or nature, such as colors, 
shapes, textures, or patterns of light and shadow 
OB 
21 when I have distressing thoughts or 
images, I just notice them and let them go 
NR 
22 I do jobs or tasks automatically without being aware of what I’m doing 
/AA 
23 I find myself doing things without paying attention 
/AA 
24 I disapprove of myself when I have illogical ideas 
/NJ 
 
correct scores for items preceded by a slash (/NJ, /AA, etc) by subtracting from 
6 
non react = 
; observe = 
; act aware = 
; describe = 
; non 
judge =