Telehealth CBT to Address Social Isolation in Veterans With Chronic Pain
Phase: NA
Conditions: Chronic Pain
Sponsor: VA Office of Research and Development

Version 3/22/2023 
  
 
 
 
 
 
 
 
 
Telehealth CBT to address social isolation in Veterans with chronic pain  
Funding Agency: RR&D 
Principal Investigator: Lisham Ashrafioun, Ph.D 
 
 
 
 

 
Page 2 of 24 
 
Abstract 
Loneliness—a subjective emotional state characterized by the perception of social 
isolation—is a psychosocial stressor that is associated with increased mortality and chronic 
pain. Individuals who have chronic pain and report loneliness experience greater pain-related 
interference in activities, depression, and suicidal ideation. Importantly, there are potentially 
effective interventions that can be used to decrease loneliness; however, there are no studies 
that have directly intervened on loneness among Veterans with chronic pain. Cognitive-
Behavioral Therapy for Loneliness (CBT-L) intervenes on loneliness by addressing negative 
beliefs that perpetuate loneliness, increase negative affect, and reduce one’s ability to engage 
in social activities. For a Veteran with chronic pain, this is critical as addressing negative affect, 
and having a sense that one has social support and engages social support are key aspects of 
increasing functioning. While CBT for Chronic Pain (CBT-CP) comprises skills to promote social 
functioning, more robust efforts may be needed to better address lonely while also addressing 
functional impairment. 
 
The proposed two-year study uses a novel application of a brief, phone-delivered, evidence-
based intervention, CBT-L, to decrease loneliness by modifying socially-relevant maladaptive 
thinking patterns, increasing engagement in enjoyable and social activities, and improving 
problem solving skills. Participants will be recruited nationally using online advertising. The 
objectives of the current proposal are to adapt CBT-L to optimize its impact on Veterans with 
chronic pain, examine if the recruitment, retention, and treatment delivery is feasible and if CBT-
L is acceptable to participants, and assess parameters of key outcomes among participants 
randomized to receive CBT-L versus CBT-CP to inform a subsequent larger clinical trial.  
 
To achieve these objectives, we will adapt a manual through an evidence-based, iterative 
process then conduct one-arm trial of CBT-L (n=8) in Veterans with chronic pain reporting 
loneliness. After refining the manual and procedures following the one-arm trial, we will 
randomize a total of 40 participants to receive either CBT-L or CBT-CP. We will assess 
loneliness, the quality and quantity of social interactions, and pain outcomes such as pain-
related interference, and pain catastrophizing at baseline and after the treatment period. We will 
also track participant flow, therapist adherence to the manual, participant homework completion 
and participant satisfaction with the treatment.  
 
 
 

 
Page 3 of 24 
 
Contents 
Study Protocol............................................................................................................................ 4 
Protocol Title:  Telehealth CBT to address social isolation in Veterans with chronic pain ........... 4 
1.0 
Study Personnel .............................................................................................................. 4 
2.0 
Introduction ..................................................................................................................... 6 
3.0 
Objectives ....................................................................................................................... 6 
4.0 
Resources and Personnel ............................................................................................... 8 
5.0 
Study Procedures ............................................................................................................ 8 
5.1 Study Design .................................................................................................................... 8 
5.2 Recruitment Methods.......................................................................................................10 
5.3 Informed Consent Procedures .........................................................................................11 
5.4 Inclusion/Exclusion Criteria ..............................................................................................11 
5.5 Study Evaluations ............................................................................................................12 
5.6 Schedule of Assessments ...............................................................................................13 
5.7 Data Analysis ..................................................................................................................14 
5.8 Withdrawal of Subjects ....................................................................................................15 
6.0 
Protection of Human Subjects ........................................................................................16 
7.0 
References .....................................................................................................................16 
 
 
 

 
Page 4 of 24 
 
Study Protocol 
Protocol Title: Telehealth CBT to address social isolation in Veterans with 
chronic pain 
1.0 
Study Personnel 
 
Principal Investigator: 
Lisham Ashrafioun, PhD 
Health Science Specialist 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Lisham.ashrafioun@va.gov 
Co-Investigators: 
Tracy Stecker, PhD 
Co-Research Director 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Tracy.stecker@va.gov 
 
Nicholas P. Allan, PhD 
Health Science Specialist 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
Nicholas.Allan@va.gov 
Research Staff: 
Park Bogan 
Project Coordinator 
Center of Excellence for Suicide Prevention 
VA Finger Lakes Healthcare System 
park.bogan@va.gov 
 
Anna Stephens 
Project coordinator 
Center of Excellence for Suicide Prevention  
anna.stephens@va.gov 
 
Monae James 
Research Assistant 
Center of Excellence for Suicide Prevention  
Monae.james@va.gov 
 
Caitlin Titus 
Research Staff 
Center of Excellence for Suicide Prevention  
Cailin.titus@va.gov 
 
Shelby Neureuter 
Research Assistant 

 
Page 5 of 24 
 
Center of Excellence for Suicide Prevention  
Shelby.neureuter@va.gov 
 
Sponsor: RR&D 
Sites: Center of Excellence for Suicide Prevention/VA Finger Lakes Healthcare System

Version 3/22/2023 
2.0 
Introduction 
Loneliness—a subjective emotional state characterized by the perception of social isolation1—is 
a critical factor that has a significant public health impact. Loneliness is evident across the 
lifespan and can be experienced by anyone, although it occurs at higher rates among those with 
psychiatric disorders, people who are objectively isolated, and people with chronic illnesses.1 
Loneliness is characterized by a discrepancy in actual and desired social relationships. This 
discrepancy is what differentiates loneliness from objective social isolation (i.e., when people 
have few social contacts). Someone who is objectively socially isolated may not be lonely, and 
someone with many social contacts may be lonely.2 A national study of adults ages 45+ found 
that over one-third reported loneliness.3 Among Veterans, 44% of a cohort of over 25,000 
reported past-month loneliness,4 and over 70% of Veterans in primary care with probable major 
depression reported past-month loneliness.5 Loneliness increases the risk for a constellation of 
chronic diseases, and can lead to the development and exacerbation of psychiatric disorders 
and suicidal behavior.2,6 A meta-analysis of 70 studies found that loneliness increases odds of 
mortality by 29% after adjusting for key covariates.7  
Loneliness is prominent and problematic in individuals experiencing chronic pain. Pain 
conditions affect over half the Veterans seen in the VHA,8 are leading causes of disability,9 have 
an estimated economic impact of over half a trillion dollars,10 and are associated with higher 
rates of psychiatric disorders, substance use, and suicide.8,11 Addressing loneliness in Veterans 
with chronic pain can have a profound impact on their psychosocial functioning and given its 
transdiagnostic nature, can impact comorbidities that are common among Veterans with chronic 
pain. Loneliness is highly prevalent among individuals with chronic pain, and pain is predictive 
of the onset of loneliness.12 National survey data indicate that 40-50% of people with chronic 
pain report loneliness.13,14 Younger adults with chronic pain experience higher rates of 
loneliness, and often identify being more withdrawn, isolated, and having fewer friends relative 
to peers without chronic pain.15,16 The high rates of loneliness among people with chronic pain is 
extremely problematic. Social isolation and more social dysfunction predict longer duration of 
sick leave for people with low back pain.17 People with pain who are more socially withdrawn or 
isolated were twice as likely to report suicide ideation.18 Among nursing home patients with pain, 
loneliness is associated with lower life satisfaction, higher depression, less mobility, and lower 
ability to complete activities of daily living.19 Among both university student and community 
samples, loneliness is associated with depressive symptoms and pain-related interference in 
activities.20,21 Patients with pain who isolate also tend to over-identify with their pain and have 
lower levels  of activity.22 Problems have been exacerbated by the COVID-19 pandemic, which 
has increased loneliness, exacerbated problems related to social resources, and reduced 
access to quality pain care.23  
Studies have sought to uncover key reasons why patients with chronic pain are lonely. Many 
indicate that pain negatively impacts socialization, and they do not feel understood by their 
social support network. Patients with chronic pain often feel like they have nothing in common 
with others and like they have few authentic and honest relationships.24 Others report feeling 
“humiliated” and self-conscious about their difficulty engaging in activities, and that their 

 
Page 7 of 24 
 
disability and negative mood prevent them from engaging in a broader range of activities.25 
Another study found that people with chronic pain want to avoid being self-pitied by others.26 
Some have separated themselves from other people because they “could not stand the laughter 
and happiness of others” making them feel more “miserable” and reluctant to start new 
relationships.27 Researchers have also posited that pain catastrophizing (i.e., thinking the worst 
about pain) and fear avoidance behaviors in patients with pain can manifest themselves as 
social isolation.28 Taken together, patients with pain experience significant suffering contributing 
to isolation and loneliness. This, in turn, contributes to behaviors that perpetuate loneliness 
because they are engaging in less activity and with fewer people who may lend support.  
To date, there are no studies that have specifically focused on addressing loneliness among 
Veterans with chronic pain. Cognitive-Behavioral Therapy (CBT) is the best way to address 
loneliness in Veterans with chronic pain. Evidence-based psychotherapies for chronic pain, 
particularly CBT for Chronic Pain (CBT-CP), have modules that indirectly address social factors 
(e.g., increasing pleasant activities, using positive coping thoughts); however, research on 
loneliness interventions suggest that these approaches are likely not adequate. Some pain-
focused treatments, such as physical activity interventions and peer led groups have found 
small effects on loneliness.19,29 However, more intensive, loneliness-focused strategies are 
needed to address loneliness as an antecedent and consequence of chronic pain. A meta-
analysis on randomized clinical trials (RCT) for loneliness found that cognitive-behavioral 
interventions significantly reduced loneliness (Hedge’s g = -0.60) to a greater extent than other 
loneliness interventions (e.g., increasing opportunities for social intervention, social skills 
training; range of Hedge’s g = -0.16-0.02).30 Kall et al.31 developed an 8-session CBT for 
Loneliness (CBT-L) and found that it decreased loneliness (Cohen’s d = 0.77) and social anxiety 
and increased quality of life at the 2-year follow-up. CBT-L addresses negative beliefs and 
cognitive biases through identifying them, and generating more balanced, alternative 
thoughts.31,32 Patients learn to approach avoided situations to assimilate new information to 
overcome fear and distress associated with social contexts. Utilizing these strategies can help 
replace avoidance of activity as viable alternatives to deal with the negative experiences 
associated with loneliness and to increase social support, which may help reduce pain 
interference. Research is needed to address loneliness among Veterans with chronic pain.  
3.0 
Objectives 
The proposed study will provide critical feasibility and acceptability data on telehealth Cognitive-
Behavioral Therapy for Loneliness and Pain (CBT-L/P) among Veterans with chronic pain who 
report loneliness. We will conduct a small single-arm trial (n = 8) for refinement of the 
intervention and study procedure. With the refined manual, Veterans with chronic pain reporting 
loneliness will be randomized to either CBT-L/P (n = 20) or CBT-CP (n = 20). The specific aims 
are as follows: 
Aim 1: Refine the CBT-L/P manual by conducting a one-arm trial among Veterans with 
chronic pain reporting loneliness (n = 8). We will deliver CBT-L/P as part of a small, single-
arm trial. This trial will allow us to collect feasibility of treatment delivery, and treatment 
satisfaction and acceptability data to further refine the manual.  

 
Page 8 of 24 
 
Aim 2: Conduct a pilot randomized clinical trial to assess feasibility and acceptability 
among Veterans with chronic pain reporting loneliness. Participants will receive either 
CBT-L for Pain (n = 20) or CBT-CP (n = 20). We will assess: (1) treatment acceptability, (2) 
participant adherence to treatment, and (3) therapist fidelity. We will also assess outcome 
measure completion percentage, means and standard deviations, and level of correlation of 
repeated measurement of social functioning and pain outcomes.  
4.0 
Resources and Personnel 
The study team consists of Drs. Ashrafioun, Allan, and Stecker, Park Bogan (coordinator), 
Anna Stephens (coordinator), Shelby Neureuter (RA), Bennett Kukla (RA), Monae James (RA) 
and research therapists (TBD) to deliver the intervention. Research therapists will have at least 
a master’s degree in a counseling/health-related field and prior CBT training Drs. Allan, Stecker, 
and Ashrafioun will be in charge of executing the scientific objectives of this project. Mr. Bogan 
will serve as project coordinator with additional assistance from Anna Stephens. The 
coordinators will assist in IRB documentation, participant payment and tracking, advertising, and 
conducting eligibility screening. The coordinators and research assistants will also complete 
screening and consent procedures, and complete assessment packets by telephone with 
participants at baseline, post-intervention and the 30-day follow-ups. Study therapists will deliver 
the study interventions. 
5.0 
Study Procedures 
5.1 Study Design 
Study sample: We will initially recruit 8 Veterans who screen positive for loneliness and have 
functional impairment from chronic pain to receive CBT-L. Once these 8 Veterans have 
completed study procedures, we will recruit an additional 40 to be randomized to either CBT-L/P 
or CBT-CP. This cohort will be randomized 1:1. The study will take place at the VA Center of 
Excellence for Suicide Prevention.  
 
Screening: Research staff will screen by phone following a script. Potential participants will 
provide verbal consent to complete the screening measures. Those individuals meeting 
eligibility who are interested in participating will be scheduled for a phone-based consent and 
baseline assessment appointment. Based on our past experience, we expect approximately 
25% of all participants who complete the screening to be eligible to and interested in 
participating. Therefore, we expect to screen no more than 600 participants to reach our sample 
of 48. 
 
Assessments and Intervention:  
 
Participants will be enrolled following consent and will complete the baseline assessment. 
Participants will schedule a convenient time for their telehealth-based intervention sessions. 
Post-treatment and 30-day post-treatment follow-up assessments will also be conducted by 
telehealth (phone, Teams, Webex, VVC), depending on the phase of the study. Participants will 
be paid $40 each assessment completed. The post-treatment assessment will also include an 
exit interview for participants to describe acceptability of the intervention. Total compensation 
will be up to $80 for the pilot phase, and $120 for the randomized phase.  
 

 
Page 9 of 24 
 
CBT for Loneliness and Chronic Pain (CBT-L/P):  
The study team recently created a draft CBT-L manual (see Appendix) starting from a 
translation of the Kall et al. CBT-L manual as the base.31 We then incorporated relevant content 
and worksheets from the VHA Brief CBT manual into the CBT-L base.32 Pain-specific materials 
need to be integrated into the manual, which will be the focus during the refinement period. 
The CBT-L adaptation for pain will use CBT-L strategies and account for impediments to 
functional improvement specific to Veterans with pain. Importantly, the approaches used will 
include those that anyone who is lonely might experience, but will also emphasize factors that 
are specific to people with chronic pain. To summarize some of the adaptations (see bulleted 
section below), participants will initially be presented with education on activating events that 
elicit thoughts, behaviors, and emotions that perpetuate loneliness, and in the case of chronic 
pain, continued impaired functioning related to pain. Sessions will then focus on identifying and 
changing unhelpful thoughts that contribute to loneliness. For example, if a participant states 
“I’m in so much pain that I’ll just yell at everyone if I leave my room,” or “It’s not worth doing 
anything because I annoy my family and I’m in too much pain,” they would be asked to estimate 
the accuracy of the thought and to dispute it. The original thoughts might be altered to “I could 
come out for a little bit and talk to people,” and “There are plenty of things that I can and have 
done and my family hasn’t been annoyed,” respectively. Assertiveness training will help 
reinforce effective strategies to improve communication with friends and family members to 
increase the likelihood of positive (or less aversive) social interactions and to communicate 
needs. Exposure and behavioral activation are used to approach feared behaviors (e.g., social 
interactions, especially those involving physical activity) and to increase the participant’s general 
activity level to improve mood. Loneliness contributes to avoidance thereby limiting use of 
adaptive coping strategies and reinforcing loneliness and negative affect. By increasing one’s 
activity level, particularly pleasant social activities involving physical activity, the participant’s 
mood may improve by decreasing avoidance, increasing the potential for social contact, 
reducing pain, and increasing self-efficacy to engage in activities. In the final sessions, the 
participant identifies barriers and ways to cope with loneliness-related problems by identifying 
strategies, evaluating the potential solutions, and selecting a plan to implement the strategies. 
This discussion will occur in the context of reducing pain flares, preventing a return to behavioral 
inactivation, and not allowing maladaptive thinking to drive poor coping, further maladaptive 
thinking, and lack of activity.  
• 
Session 1: CBT Model & Goal Setting  
o Pain integrated into CBT model; goals also associated with addressing pain-
related functional impairment 
• 
Session 2: Identifying & Challenging Thoughts I 
o Pain-related thoughts perpetuating loneliness; loneliness-related thoughts 
perpetuating pain 
• 
Session 3: Identifying & Challenging Thoughts II 
o Continued focus pain-related thoughts perpetuating loneliness; loneliness-related 
thoughts perpetuating pain 
• 
Session 4: Assertiveness Training 
o Teaching effective communication and conflict resolution 

 
Page 10 of 24 
 
• 
Session 5: Exposure & Behavioral Activation I 
o Incorporating physical activity into exposure and behavioral activation related to 
social activities 
• 
Session 6: Exposure & Behavioral Activation II 
o Incorporating physical activity into exposure and behavioral activation related to 
social activities 
• 
Session 7: Problem Solving 
o Problem solving issues around functional limitations, mobility, and other pain-
related barriers 
• 
Session 8: Review & Relapse Prevention 
o Review is specific to new content, using skills for CBT-L to address pain flares 
CBT-CP: A Cochrane review indicated that CBT-CP reduces pain intensity, disability, mood 
outcomes, and pain catastrophizing.33 CBT-CP is a nationally disseminated, evidence-based 
intervention with the goal of increasing functioning and quality of life through adaptive pain 
coping skills to support self-efficacy to manage pain.34-36 This is accomplished through pain 
psychoeducation, increasing activity level (e.g., walking, pleasant activities), and identifying and 
challenging pain catastrophizing. This CBT-CP protocol will be reduced from 10 to 8 sessions to 
match the number of sessions to CBT-L. The sleep hygiene session will be removed, and goal 
setting will occur in session 1 (rather than a stand-alone session). Both changes are consistent 
with Brief CBT-CP that was created in the VHA.37 The manual is included as an Appendix. 
Therapist training and fidelity. The investigators will provide training on CBT-L/P and CBT-
CP. The training will begin with a training session provided, which will involve a review of basic 
CBT principles, rationale for using CBT-L/P and CBT-CP based on empirical support, and a 
detailed description of CBT-L/P and CBT-CP with the manual and handouts. Training will 
include didactics, guided readings as needed, role playing, and supervised training cases as 
needed until competency is met. We will monitor treatment fidelity by audio recording all CBT-
L/P intervention sessions via Teams, Webex, VA Video Connect, or a FIPS-compliant recorder. 
Once coders are reliable, we will randomly code 30% of these sessions to be coded separately 
by two independent raters with 20% of these double coded. We will use the fidelity tool during 
the delivery of the intervention to continue monitoring adherence and competence to deliver the 
treatment materials. During the treatment delivery, feedback will be given weekly to the therapist 
during supervision sessions to ensure fidelity to the intervention protocol is maintained. 
 
5.2 Recruitment Methods 
Recruitment and retention procedure: Participants will be recruited using Internet social media 
websites (e.g., Facebook, Reddit) and select print/web portals that have been used successfully 
in several large studies. Advertisements will include a link to a study landing page with study 
information and blank entry forms for interested Veterans to enter contact information through 
VA Qualtrics on Fedramp, a secure, FISMA-compliant server used across government agencies 
with an authority to operate with the VA. We plan to enroll 48 participants in the protocol overall.  
 
Participants will also be recruited through a data access request using data from the Corporate 
Data Warehouse (CDW). CDW contains financial, enrollment, demographic, diagnostic, 
treatment utilization, and other data across Veterans from 1979 to present. All study staff will be 
trained on accessing these records by Dr. Ashrafioun. Joint Longitudinal Viewer will be used to 
access medical records to prioritize recruitment of Veterans who are more likely to be eligible. 

 
Page 11 of 24 
 
This pre-screening will help reduce Veteran burden and unnecessary contact of Veterans who 
would not be eligible. Participants identified through this method will be screened using the 
same criteria as those recruited through social media websites and select print/web portals as 
described above. Potential participants will be mailed a personalized letter describing the study 
and provided with a so that they can contact study staff if they are interested in participating as 
well as opt out of future contact. Potential participants may be recruited from other studies that 
are IRB approved following completion of those other studies or if deemed ineligible. Only study 
staff that are approved on those studies will recruit those participants. Providers may also refer 
participants to the study by emailing the research staff/team. Providers will be given the 
approved recruitment letters that are provided to Veterans as well as the approved study 
landing page for information (content can be found on p. 55 of the approved advertising pdf). 
 
Participants will receive compensation for their participation in the study. The compensation 
amount will be based on the schedule that follows: 
 
 
Baseline Assessment  
 
 
$40  
 
Post-treatment Assessment   
 
$40 
 
30-day Assessment (RCT only) 
 
$40 
    
 
Therefore, the total compensation for completing all the study components would be $80 for the 
Aim 1 one-arm trial and $120 for the Aim 2 RCT. Payments will be made via direct deposit or 
check following each study procedure listed above. Participants who do not complete the entire 
study for any reason will receive compensation for the components that were completed per the 
above schedule of payments. 
5.3 Informed Consent Procedures 
There are two phases where informed consent could be obtained, when completing the 
screening for eligibility and when enrolling into the study following the screening and if eligibility 
criteria are met. Verbal consent to participate will be obtained for the screening and baseline 
appointment. Informed consent will be obtained by study personnel trained in human subjects’ 
protections requirements and how to obtain and document informed consent.  
5.4 Inclusion/Exclusion Criteria 
Inclusion criteria: Participants will include men and women who: 
• 
Are English-speaking  
• 
Are 18 years of age or older 
• 
Have access to a phone or computer 
• 
Report pain that occurs on at least half the days for six months or more 
• 
Score at least 4 (of 10) on each of the three items on the PEG (Pain intensity, and Pain 
interference in Enjoying activities and General activities) 
• 
Screen positive for loneliness by scoring at least a T-score > 60 on the NIH Toolbox 
loneliness scale 
We will use the Veteran Verification screening for Veterans recruited through social media 
advertising to help confirm Veteran status. 
Exclusion: Veterans will be excluded on the basis of: 
• 
Do not understand informed consent  
• 
Had a recent or have an upcoming surgery 

 
Page 12 of 24 
 
• 
Have significant unstable or uncontrolled medical conditions, including cancer requiring 
ongoing oncology treatment  
• 
Active severe substance use disorder 
 
Pregnant women will not be excluded from this study as no invasive medical procedures are 
being performed and there is no known risk to the mother or the fetus of the proposed 
interventions. The study will not include prisoners or institutionalized Veterans. 
5.5 Study Evaluations 
 
Loneliness: The 20-item Revised UCLA Loneliness Scale will be our primary outcome 
measure.38 We will use the 5-item NIH Toolbox Loneliness Scale39  as our loneliness screening 
measure. The NIH Toolbox Loneliness Scale is correlated highly (r = .80) with the Revised 
UCLA Loneliness Scale.5,39 T-scores >60 indicate loneliness scores 1 standard deviation above 
the mean and will be used to assess eligibility.40 
Quality/Quantity of Social Interactions: The Duke Social Support Index (DSSI) assesses 
several domains of perceived social support, including social network size, social interaction, 
social satisfaction, and instrumental social support. Research supports the psychometric 
properties of the DSSI scales.41-43 Belongingness and Burdensomeness: The Interpersonal 
Needs Questionnaire (INQ-12) assesses thwarted belongingness (i.e., an unmet need to 
belong) and perceived burdensomeness (i.e., feeling like a burden to one’s social support 
network). Research supports the scale’s psychometric properties.44 
Pain variables: The Brief Pain Inventory45 will be used to assess pain severity and pain 
interference. Pain severity consists of 4 items assessing current, average, worst, and least pain 
experienced. The pain interference subscale comprises 7 items assessing the extent to which 
pain interferes with various aspects of one’s life (e.g., mood, sleep, daily activities).45 Pain 
Catastrophizing: The Pain Catastrophizing Scale (PCS)46 is a 13-item measure, with each item 
rated on a 5-point rating scale (0 = “Not at all” to 4 = “All the time”). The measure is divided into 
three subscales: magnification, rumination, and helplessness and has strong psychometric 
properties.46 Pain Self-efficacy Questionnaire (PSEQ). The PSEQ assesses one’s confidence in 
performing activities while in pain. The PSEQ has demonstrated good construct and convergent 
validity along with high test-retest reliability.47 Tampa Scale for Kinesiophobia (TSK): The TSK-
11 is an 11-item measure assessing pain-related fear of movement or injury. Research supports 
the scale’s psychometric properties.48 Current Opioid Misuse Measure (COMM): The COMM is 
a 17-item measure that will be used to assess the frequency of aberrant drug-related behaviors 
and other behaviors that are prevalent among pain patients who are misusing prescription 
opioids (e.g., frequent visits to the emergency department). The rating scale on the COMM 
ranges from 0 (“Never”) to 4 (“Very Often”), with higher scores indicating greater risk of misuse 
of prescription opioids. The COMM has demonstrated strong psychometric support.49  
 
Other key descriptive variables: Treatment utilization: We will assess participant past and 
current substance use, non-pharmacological pain treatment, mental health treatment utilization 
at baseline and follow-up. We will also assess primary care and specialty medical care visits, 
both within and outside the VA. This will be done using a modified version of the Treatment 

 
Page 13 of 24 
 
Services Review (TSR).50 Quality of life: The PROMIS Profile-29 will be used to assess the 
following: anxiety, depression, physical function, fatigue, sleep disturbance, and ability to 
participate in social roles and activities.51 The pain interference items were removed because 
they are redundant with the Brief Pain Inventory. Suicidal thoughts and behaviors: For the 5-
item Paykel Suicide Scale,52  respondents will be asked to indicate (yes or no) if they had: (1) 
felt that life was not worth living, (2) wished, (3) thought about, (4) seriously considered, and/or 
(5) attempted suicide in the past year (at baseline)/since last visit (for all other assessments). 
Participants receive a score equal to the greatest magnitude of suicidal ideation or behavior 
positively endorsed. Demographics and military background. At screening, we will assess 
participants’ branch, deployment history, gender, age, educational background, employment, 
income, race, ethnicity, and marital and cohabitation status. 
Exit Interview and Treatment Acceptability. The exit interview will assess overall impressions 
and impact of treatment, relationship with the therapist, and areas of improvement (See 
Appendix) to inform modifications to improve feasibility and acceptability. A modified 
Abbreviated Acceptability Rating Profile (AARP) will also assess acceptability.53  
5.6 Schedule of Assessments 
 
Schedule of Assessments – One Arm Trial 
Measures 
Screening 
Baseline 
Post-treatment 
Eligibility Review 
X 
  
  
NIH Toolbox Loneliness Scale   
X  
  
PEG 
X 
 
 
Demographics and Military Background 
  
X 
Brief Pain Inventory 
 
X 
X 
Revised UCLA Loneliness Scale 
  
X 
X 
Duke Social Support Index (DSSI) 
  
X 
X 
Treatment Services Review (TSR) 
  
X 
X 
PROMIS-29 (less pain subscale) 
  
X 
X 
Interpersonal Needs Questionnaire-12 
  
X 
X 
Pain Catastrophizing Scale (PCS) 
 
X 
X 
Tampa Scale of Kinesiophobia 
 
X 
X 
Pain-related Self-Efficacy Questionnaire (PSEQ) 
 
X 
X 
Paykel Suicide Scale 
 
X 
X 
Current Opioid Misuse Measure (COMM) 
 
X 
X 
Exit Interview/Abbreviated Acceptability Rating 
Profile (AARP)  
  
  
X 
 
Schedule of Assessments –Randomized Clinical Trial 
 

 
Page 14 of 24 
 
Measures 
Screening 
Baselin
e 
Post-treatment 
1-mo 
follow
-up 
Eligibility Review 
X 
  
  
 
NIH Toolbox Loneliness Scale   
X  
  
 
PEG 
X 
 
 
 
Demographics and Military Background 
  
X 
X 
 
Brief Pain Inventory 
 
X 
X 
X 
Revised UCLA Loneliness Scale 
  
X 
X 
X 
Duke Social Support Index (DSSI) 
  
X 
X 
X 
Treatment Services Review (TSR) 
  
X 
X 
X 
PROMIS-29 (less pain subscale) 
  
X 
X 
X 
Interpersonal Needs Questionnaire-12 
  
X 
X 
X 
Pain Catastrophizing Scale (PCS) 
 
X 
X 
X 
Tampa Scale of Kinesiophobia 
 
X 
X 
X 
Pain-related Self-Efficacy Questionnaire (PSEQ) 
 
X 
X 
X 
Paykel Suicide Scale 
 
X 
X 
X 
Current Opioid Misuse Measure (COMM) 
 
X 
X 
X 
Exit Interview 
  
  
X 
 
 
5.7 Data Analysis 
We will track rate of recruitment per week, and the percentage of participants who 
complete the protocol, and each follow-up. Participant treatment adherence will be assessed by 
tracking attendance and homework completion. Session-by-session participant feedback will be 
used to examine potential reasons for drop-out and non-adherence to inform our small RCT. 
Therapist adherence scores for the individual sessions and the overall interventions will be 
assessed as the percentage of the content delivered. Interrater reliability for fidelity will be 
assessed using intra-class correlation coefficients. We will assess the internal consistency of 
competence using Cronbach’s alpha. Treatment acceptability will be assessed with the modified 
AARS and exit interview for a richer understanding. For participants who choose to withdraw 
prior to completing the full protocol, attempts will be made to conduct exit interviews to assess 
treatment experiences and reasons for early withdrawal. Interviews will be audio-recorded and 
transcribed. Interview data will be analyzed using matrix analysis,54-56 a systematic technique for 
data reduction to thematically organize and analyze data using rows, columns, and cells of a 
table. This process is time efficient, aligns well with results of in-depth analyses, allows for 
accurate summarizing of data, and facilitates participant comparisons.55Matrices are also an 
effective way to share findings with interdisciplinary team members for discussion.54 Following 
the analyses, these matrices will be reviewed by the investigative team and expert panel in 
preparation for finalizing the intervention. 
 
 
Consistent with descriptive analyses for pilot studies,57 measure completion percentage 
and means and standard deviations for outcomes will be calculated at each assessment, 
including change scores and correlations across timepoints. We expect large standard errors 

 
Page 15 of 24 
 
due to small sample size. Distribution of scores will be examined to better evaluate how to 
analyze these data in future studies (e.g., dichotomizing/ categorizing vs. continuous). 
Correlations among baseline variables will be calculated to assess the potential for variables to 
be included as covariates in the larger trial. This may also be useful in identifying potential 
moderators and mediators for the future larger trial. For data quality and handling of missing 
data, descriptive statistics will help identify out of range values and outliers. We will examine 
bias in retention rates at both the univariate and multivariate level of analyses 
 
Data storage, security, and confidentiality 
Several procedures for protecting participant confidentiality will be implemented to reduce 
the risk of revealing participant identity. All informed consent forms will contain identifying 
information. In order to ensure confidentiality, each consent form will be labeled with a numeric 
identifier and will be stored in a double-locked file. These will be stored in separate double-
locked files from other study materials. As noted in the Data Transport Memorandum, locked 
courier bags will be used to transport any sensitive study information (e.g., consents) outside 
VA. 
The VA Informatics and Computing Infrastructure (VINCI) will be used for the storage of 
study data. VINCI is a major informatics initiative of the Department of Veterans Affairs (VA) that 
provides a secure, central analytic platform for performing research and supporting clinical 
operations activities. It is a partnership between the VA Office of Information Technology (OI&T) 
and the Veterans Health Administration Office of Research and Development (VHA ORD). 
VINCI includes a cluster of servers for securely hosting suites of databases integrated from 
select national VA data sources. VINCI servers for data, applications and virtual sessions are 
physically located at the VA Austin Information Technology Center (AITC), located in Austin, 
Texas. This secure enclave with 105 high-performance servers and 1.5 petabytes of high-speed 
data storage has multiple layers of security and disaster recovery to prevent data loss. 
Study data will be kept in accordance with the Department of Veterans Affairs Record 
Control Schedule 10-1 (RCS 10-1). Storage and transfer of any Personally Identifiable 
Information (PII) or Protected Health Information (PHI) must be done in accordance with 
applicable VA and VHA policies and directives, state and federal regulations, and applicable 
statutes including the Health Insurance Portability and Accountability ACT (HIPAA). Unless 
explicitly requested and approved by data stewards, all sensitive patient data must remain on 
VINCI project servers and only aggregate data without PII / PHI may be transferred from VINCI. 
Prior to being uploaded to VINCI for analysis, data will be stored on a secure VA server, 
which is password protected, and to which only IRB approved VA research personnel have 
access. Should any identifiable information need to be shared, research teams will utilize a 
secure, SharePoint site or electronic communication with PKI encryption. Any identifiable paper 
data will be stored in two separate locked file cabinets (one for informed consents and the other 
for paper questionnaire data) in the offices of the Center for Excellence for Suicide Prevention at 
the VA Finger Lakes Healthcare System in Canandaigua, NY. After a participant completes the 
study, any identifiers will be removed from the paper questionnaire data immediately. Data 
analysis will occur in the VINCI framework. 
 
5.8 Withdrawal of Subjects 
Participants who wish to withdraw may do so at any time without affecting their medical care or 
participation in any other study. Participants will be informed of any new information during the 
course of the study which may affect their condition or influence their willingness to continue in 
this study. Finally, based on decisions made by the Principal Investigator, participants may be 
taken out of the study because of unanticipated circumstances such as extreme distress. That 

 
Page 16 of 24 
 
is, they may be withdrawn from the study if we judge that participating is not in their best 
interest. 
6.0 
Protection of Human Subjects 
 
Risk to Participants 
  
Human Subjects Involvement and Characteristics. The purpose of this study is to assess the 
feasibility and acceptability of an intervention designed to improve social functioning and pain 
interference in functioning among Veterans with chronic pain. A total of 48 participants (n = 8 for 
the Aim 1 one-arm trial and n = 40 for the Aim 2 RCT) will be recruited across the US. According 
national survey data, 65.5% of Veterans reported experiencing pain in the last 3 months. While 
Veterans reporting pain tended to be older (60+ years = 56.5%), 12% were comprised of 18-39 
year olds, 13.4% were comprised of 40-49 year olds, and 17.9% were comprised of 50-59 year 
olds. 92.5% were men, while just 7.5% were women, however, women were slightly more likely 
to report pain in the last 3 months compared to men (70.1% vs. 65.3%). VHA data indicate that 
medical and psychiatric comorbidity is high among Veterans with musculoskeletal conditions 
(many of which are associated with chronic pain). We expect that the recruitment pool will be 
similar to the above estimates; however, we will use recruitment ads to promote recruitment of 
women and Veterans with minority status to increase representation in our sample.  
 
Source of Materials. Study materials will include self-report questionnaires. The materials will 
be collected for study purposes only. Information collected will be stored in a locked filing 
cabinet in a locked office at the study sites that can only be accessed by members of the study 
team. All electronic data will be stored on VA Informatics and Computing Infrastructure (VINCI) 
project servers. Only approved study team personnel who will be involved in data entry, 
management and analyses will be granted access to this data. All computers are password 
protected.  
Potential risks.  
Psychological distress. Anticipated risks to the participants from assessment procedures and 
therapy are minimal; however, participants may experience psychological distress, frustration, 
and/or fatigue. The semi-structured interviews, assessments associated with the intervention, 
and therapy sessions may encourage participants to recall personal events and life stressors 
that may evoke distress. Additionally, confidentiality may need to be breached if a participant 
poses a threat to him or herself or others, including child abuse. 
 
Adequacy of Protection from Risk  
Recruitment and Informed Consent.  
All research staff conducting recruitment and informed consent will have completed appropriate 
and up-to-date training in research, research ethics and the proper conduct of research that 
includes common issues related to recruitment and informed consent.  
 
Participants will be recruited using Internet social media websites and select web portals. 
Advertisement will nationally target Veterans who are experiencing functional impairment from 
chronic pain and who may be lonely. Targeted recruitment of women Veterans will also be used 
for advertisements. All sites will send participants to a study landing page, which serves as a 
central location for potential participants to follow-up with the study team via phone or 
completing and submitting an online form.  

 
Page 17 of 24 
 
 
Participants will also be recruited through a data access request using data from the Corporate 
Data Warehouse (CDW). CDW contains financial, enrollment, demographic, diagnostic, 
treatment utilization, and other data across Veterans from 1979 to present. All study staff will be 
trained on accessing these records by Dr. Ashrafioun. Joint Longitudinal Viewer will be used to 
access medical records to prioritize recruitment of Veterans who are more likely to be eligible. 
This pre-screening will help reduce Veteran burden and unnecessary contact of Veterans who 
would not be eligible. Participants identified through this method will be screened using the 
same criteria as those recruited through social media websites and select print/web portals as 
described above. Potential participants will be mailed a personalized letter describing the study 
and provided with a so that they can contact study staff if they are interested in participating as 
well as opt out of future contact. 
 
Recruitment and informed consent procedures were designed to ensure patients do not feel like 
participation is required. Potential participants unable to understand the informed consent 
process will be excluded from participating. Screening interviews will be completed initially over 
the telephone (using a script) to assess eligibility criteria. Verbal consent will be obtained at this 
time to complete the screening. Participants screening positive for exclusion criteria will not be 
included in the study. For eligible and interested participants, a research coordinator will review 
the consent form and complete a brief questionnaire to ensure the potential participant 
understands the study. As with Dr. Stecker’s other phone-based interventions, consent will be 
obtained verbally following the above outlined procedure. The participant will be mailed or 
emailed a copy for their records.  
 
Participants will receive compensation for their participation in the study. The compensation 
amount will be based on the schedule that follows: 
 
 
Baseline Assessment  
 
 
$40  
 
Post-treatment Assessment   
 
$40 
 
30-day Assessment (RCT only) 
 
$40 
 
 
 
Therefore, the total compensation for completing all the study components would be $120. 
Payments will be made following each study procedure listed above. Participants who do not 
complete the entire study for any reason, will receive compensation for the components that 
were completed per the above schedule of payments. 
 
Protection Against Risk.  
Psychological distress. The potential risks are negligible. There are no known risks associated 
with interview procedures.  Participants will be informed that they may feel slightly 
uncomfortable discussing some of their symptoms.  Mild discomfort may be likely during the 
intervention session; however, this is unlikely to have a serious negative impact on the 
participant’s well-being.  Participants will be told they can withdraw from the study at any time.  
Participation or withdrawal from the study will not affect any benefits to which they are otherwise 
entitled.  Special precaution will be taken to safeguard confidentiality. During assessments, if 
the interviewer is concerned about thoughts and planning of a suicide attempt, the interviewer 
will ask two follow-up questions: Do you have a desire to kill yourself that you think you might 
act on and Do you have a plan for killing yourself and intend to carry the plan out? With this 
information and available suicide assessment measures, the interviewer will evaluate the 
severity of the participant’s suicide risk. If the participant is deemed to be at imminent risk, a 
safety plan will be initiated. All study staff will receive adequate training in suicidal ideation and 

 
Page 18 of 24 
 
risk assessment, and all work will be supervised by Drs. Ashrafioun or Stecker, who are 
licensed clinicians. 
 
Some individuals may experience more severe suicidal ideation at one or more of the 
assessment or intervention sessions given that loneliness and chronic pain are both associated 
with suicide. Therefore, we include here the proposed safety procedures that we have used in 
other studies with similar populations.  
 
All assessors and interventionists will have a specific protocol to follow regarding emergency 
care and will have the clinical back-up of Drs. Ashrafioun and Stecker. This study will use safety 
procedures that have been previously approved by the IRB in several of our protocols. All 
research staff will be thoroughly trained on these procedures. These include written procedures 
for handling emergencies, a written procedure for conducting a full suicide risk assessment 
whenever suicidality is endorsed (note that for this study the Columbia Suicide Severity Rating 
Scale), procedures for participants endorsing a suicidal plan or intent (including staying with a 
patient until they are connected with a mental health provider or 911 help), and a written warm-
handoff guideline to connect Veterans to the National Veterans/Military Crisis Line (VCL).  
 
Besides responses on study assessment instruments, participants may also allude to suicide or 
make other provocative statements, irrespective of the scale rating, and in these instances 
research staff may also decide to transfer the participant to the VCL.  
 
For example, a participant may score in the severe depression range on the PHQ-9 depression 
scale and, together with other information obtained during the call, the research assistant may 
perceive acute risk and decide to transfer the participant to the VCL.       
 
In any of the above instances, the research staff member will read (or paraphrase) the following 
statement to the participant at the end of the call:  
 
I am concerned about your safety and so at this time I am going to transfer you to speak 
with one of our mental health clinicians at the Veterans/Military Crisis Line. There will be 
a moment of silence as I connect you.  If for some reason we get disconnected please 
dial 1-800-273-8255 and press #1 to reach the Lifeline. I will stay on the line with you 
until the transfer is complete.  I am now going to transfer you.  Please stay on the line.   
 
The researcher will briefly summarize the participant’s situation to orient the VCL responder to 
the nature of the call (the participant will hear a moment of silence at this time, and then the 
participant will be transferred to the VCL.  
 
If the participant hangs up or becomes disconnected, the researcher will call the VCL 
immediately, and the VCL staff will take necessary actions as appropriate according to the VCL 
safety protocol and/or direct the researcher what actions to take. These actions may include 
initiating a “rescue” that involves calling 911 at the participant’s local jurisdiction and having 
emergency personnel come to the participant’s home to ensure their safety. The VCL staff 
performs rescues every day, and all rescues are done in collaboration with a supervisor.    
We have ongoing collaborations with the VCL and have substantial experience working with 
responders and supervisors. Our approach to participant safety will be applied to all participants 
including control participants and is guided by ongoing clinical and research experience in 
suicide prevention, including our Center Director’s affiliation with the VCL.   
 

 
Page 19 of 24 
 
We will collaborate closely with the VCL during the study start-up phase to review these safety 
protocol steps. The VCL, which was established in 2007 at the Canandaigua VAMC, can be 
reached anytime by calling 1-800-273-8255. The VCL has grown to be one of the largest in the 
world, with a full-time staff of more than 600 full-time responders. VCL responders are paid 
professional staff and nearly all have a Master’s degree in a relevant field (e.g., mental health 
counseling), distinguishing the VCL from others in the U.S. that are staffed primarily with 
volunteers.   
 
VCL resources will be available as back-up at all times during study sessions.  VCL responders 
are arguably the foremost experts in managing acute suicidal crises via telephone. They have in 
place protocols for locating suicidal individuals, identifying the closest police and emergency 
medical services, and monitoring and documenting “rescues.”  Moreover, VCL responders have 
the ability to look up call histories based on callers’ phone numbers, a capability that since 
implemented has greatly aided the ability of responders to rapidly assess callers’ needs.   
 
All participants will be provided the VCL phone number at the end of each baseline assessment 
and at each follow-up assessment and encouraged to call the number should they become 
suicidal, simply wish to talk with someone, or would like assistance in obtaining a referral for 
mental health treatment. In situations in which potential suicide risk is identified during a phone 
call, we plan to use two levels of response: 1) researcher transfers the individual to the VCL 
(used in acute crises requiring emergency intervention or “rescue”); 2) researcher offers the 
participant a transfer to the VCL, but does not perform the transfer if he/she does not wish to be 
transferred (used in non-emergency situations).    
 
Breach of Confidentiality. Statistical electronic data files will be kept VINCI project servers 
maintained by VINCI OI&T personnel and only summarized data without protected health 
information (PHI) will be downloaded from VINCI to local storage media. Research staff will use 
an audited VINCI download utility to move summarized data for reports, presentations and 
publications from VINCI servers to local storage media. The VINCI download utility provides an 
audit path including a copy of the downloaded material. The data extraction tool will be adapted 
for use with software directly available on the VINCI platform (e.g. Microsoft Word and Excel) 
and study data will be stored and maintained on VINCI. All study team personnel with access to 
sensitive patient data will stay current on their VA approved information security training and VA 
approved privacy policy training.  
 
Adverse Events (AE). AEs may include, but are not limited to: worsened physical or mental 
health, or inadvertent disclosure of confidential research information. Serious Adverse Events 
(SAE) may include: death, hospitalization due to worsening psychiatric symptoms or suicidal 
ideation, or all life threatening or disabling/incapacitating events among research participants. 
Per IRB regulations, SAEs, any event resulting in a deviation from the study protocol (e.g., 
emergency hospitalization to address suicidal behaviors) or death will be reported to the PI 
within 24 hours and to the IRB in 48 hours. This will be completed in order to assess 
significance and determine an appropriate response. AEs that involve temporary distress will be 
noted by interviewers and provided to the IRB in an annual report.  
 
Confidentiality of Records:  Numerous protections are in place to reduce the likelihood of loss 
of confidentiality. All research data will be kept in locked filing cabinets in secure areas, absent 
of identifying information, and coded by research number only. Files containing consent forms 
and other items with identifying information will also be kept in locked filing cabinets, but these 
will be separate from cabinets containing data from this study. All electronic files will be 
maintained on a secure study folder behind the VA firewall. Only approved study team 

 
Page 20 of 24 
 
personnel will be granted access to this data. All identifiable information will be stored in a 
separate folder behind the firewall from the de-identified study ID and data. 
 
Potential Benefits of Research to Participants and Others. There may be direct and/or 
indirect benefits of study participation. Participants are receiving an intervention that addresses 
a transdiagnostic factor that may reduce pain-related interference in activities. This intervention 
can be used for both participants who are not engaged in treatment and for participants who are 
engaged in treatment, it may augment current services. Dissemination of the findings from the 
study will contribute to the extant literature, and may contribute to reducing loneliness and pain.  
 
Importance of Knowledge to be Gained. Understanding how to effectively address loneliness 
among Veterans with chronic pain is a critical approach to curb significantly impairing chronic 
pain. Loneliness is associated with increased suicide risk, worse pain outcomes, and 
depression among individuals with chronic pain. Addressing loneliness has the potential to 
reduce functional impairment from chronic pain. The proposed study tests the 8-session CBT-L 
that is delivered by phone targeting cognitive biases, and avoidance of social interactions and 
enjoyable activities. We expect that this intervention will reduce loneliness, increase the quality 
and quantity of social interactions, and reduce functional impairment from chronic pain. It will lay 
the foundation for understanding best practices of addressing loneliness and pain.  Knowledge 
gleaned from this study will help inform future implementation and dissemination efforts, which 
can be used across numerous settings.  
 
Data Safety & Monitoring Plan 
 
Data Safety. To ensure safety of participants in the study proposed and validity and integrity of 
data collected, the PI (Ashrafioun) will oversee all data and safety monitoring functions and the 
research team will be advised that he will be the primary contact overseeing these activities. 
The investigators will meet regularly to monitor study progress and discuss the implementation 
of monitoring procedures. The PI will also meet regularly with the research coordinator and staff 
to review monitoring procedures and ensure all efforts are being taken to minimize risks to 
participants. As indicated below, the PI will track all negative outcomes and incidents as well as 
conduct interim data analysis every 12 months after the study has started. The study design will 
be significantly modified (and even screening stopped) if the study is creating potential harm to 
our participants.  
 
The PI and Dr. Stecker will regularly oversee all aspects of the study, including participant 
recruitment, informed consent, data collection, management, and analysis, as well as regularly 
assess the risk/benefit ratio associated with participation in the study. All research staff will 
participate in an intensive training to help them understand the importance of reducing the risk 
for participants and learning how to recognize and report any AE or SAE. SAEs may include: 
death, hospitalization due to worsening psychiatric symptoms or suicidal ideation, or all life 
threatening or disabling/incapacitating events among research participants. AEs may include, 
but are not limited to: physical injuries, worsened physical or mental health, or inadvertent 
disclosure of confidential research information. 
 
If an SAE occurs, the PI will immediately contact the IRB, followed by a written report in 24 
hours. He will make a decision whether there is sufficient evidence to suspend data collection, 
allow for further IRB review, modify the protocol, or make other changes to reduce potential risk 
to participants. The study will resume based on agreement of the PI and IRB chair. In the event 
that an AE that is not an SAE is reported to the PI, the PI will discuss the event with the IRB 
chair. Immediate evaluation will occur to determine if any extra steps can be taken to minimize 

 
Page 21 of 24 
 
the likelihood of that type of AE occurring again. If changes can be made, a report/amendment 
will be written and submitted to the IRB.  
 
As part of a standard practice, the PI will supervise the implementation of one audit regularly per 
year of the materials collected and produced as part of the study to ensure proper confidentiality 
and compliance with ethical principles, including informed consents, questionnaire data, and to 
make sure that the research staff are following established protocols. The PI will provide an 
annual summary report of all AEs to the IRB as part of the annual review. If no adverse events 
have occurred, the report will state, “No adverse events affecting human participants have 
occurred during this project year.”    
 
Data Monitoring. To ensure adequate participant recruitment and enrollment, each week, the PI 
will discuss the current number of participants contacted, screened, and enrolled from each site 
and compare those numbers to the expected based on our preliminary data. If after the first 4 
months, it appears we are not reaching our expected number of participants, the PI will discuss 
potential barriers/obstacles and solutions. Discussions regarding recruitment and enrollment will 
continue at each meeting with study staff to ensure proper implementation of the study. 
 
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