Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Phase: NA
Conditions: Alzheimer Disease, Musculoskeletal Pain, Chronic Pain
Sponsor: Palo Alto Veterans Institute for Research

 
 
 
 
 
 
 
 
At-Home Telehealth Yoga for Treating Chronic Pain in People with Alzheimer's 
Disease and Their Caregiver's 
 
 
 
Study Protocol and Statistical Analysis Plan  
 
 
 
NCT #: 04512040 
 
 
 
February 02, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background 
Pain is the most common health complaint in the general population, and within primary 
care (14). Chronic pain is usually defined as pain persisting for at least 3 months, although many 
patients suffer pain for years or even decades (15). Chronic pain affects approximately 50% - 
78% of veterans (1, 2) with the prevalence of pain increasing with age (12). Chronic pain is the 
leading cause of work disability globally (16) and costs the US more than $500 billion each year 
in lost productivity (17). Chronic pain is treatment-resistant, and pharmaceuticals often bring 
limited benefit and have significant side effects and risks. The use and abuse of opiates to treat 
pain has become a major public health issue (18-20). Most chronic pain is musculoskeletal, 
which is defined as pain from the body’s joints, ligaments, muscles, nerves, tendons, and 
structures that support the limbs, neck, and back (21). In 2012, 54.5% of U.S. adults reported 
musculoskeletal pain (22). Chronic musculoskeletal pain is even more common in veterans than 
nonveterans, with a prevalence of 50-75% (2, 23, 24). 
Increasing age is the single biggest risk factor for AD (25). AD affects nearly 5% of 
persons aged >65 years (26) and nearly one third of those aged ≥85 years (26). AD is 
characterized by neurodegeneration and is accompanied by a range of cognitive and behavioral 
problems (27). Like AD, the incidence of chronic pain increases with age (28). Because both 
chronic pain and AD are strongly linked to age, they are often comorbid, and studies have shown 
a high prevalence of pain in AD. A recent meta-analysis involving 50,911 AD patients estimated 
the prevalence of chronic pain in AD to be 46% (3). This figure may be an underestimate 
because AD patients may be less able to communicate their pain, and request attention less 
effectively than their cognitively intact peers (29). Both chronic pain and AD are associated with 
behavioral and psychological problems including depression (30), insomnia (31), cognitive 
decline (32) and greater functional dependence (32). The co-morbidity of chronic pain in AD can 
therefore amplify symptoms, leading to poorer outcomes (32, 33). Moreover, recent studies have 
suggested a biological link between the two conditions such that chronic pain and AD may 
involve two intertwined pathological processes that can accelerate AD pathogenesis (34). 
As life expectancy increases, the increase incidence of AD has become a major concern. 
The VA has estimated current and future numbers of veterans with dementia (35). The mid-range 
estimates for the enrolled population for 2019 were 408,933 cases of dementia, and by the year 
2029, 465,636 cases dementia (high range estimates for the same time periods were 571,148, and 
688,342 cases, respectively). Since AD accounts for ~70% of all dementia cases (36) and chronic 
pain affects approximately 50% - 75% of veterans (16, 17), it is estimated that 223,277 veterans 
have co-morbid chronic pain and AD, which will rise to 254,237 by 2029. Since approximately 
5.8 million Americans have AD (36) and the prevalence of chronic pain in AD is 55% (3) this 
translates to about 3.2 million patients in the US general population currently living with both 
AD and chronic pain. 
Nonpharmacological management of chronic pain is high on the list of priorities for both 
NIH (37) and the VA (38). Cognitive behavior therapy (CBT) is the gold standard behavioral 
intervention for chronic pain (39). However, effect sizes for CBT for chronic pain are relatively 
small, with only 43% of CBT trials demonstrating improvements in pain (40). Furthermore, CBT 
dropout rates are high (41-43). For these reasons, interest is increasing in integrative approaches 
to health and wellness (44). A recent survey reported CIH techniques are used by ~35% of US 
adults (45) and CDC data shows that among the movement practices (yoga, tai chi, and qi gong), 
yoga has increased most over the decade 2002 – 2012 (8), accounting for ~80% of 

CIH use. Two key statistics are relevant. First, a recent survey showed rates of participation in 
CIH practices including yoga were significantly higher among those with a musculoskeletal pain 
disorder (22) than among persons without such a disorder (41% vs. 24%, respectively). Second, 
patients with neurological conditions including AD use yoga more frequently than those without 
neurological conditions (~25% vs. ~17%, respectively) (10). The trend is clear: yoga is 
increasingly being by AD patients, and more research is needed. 
No studies have examined the effects of yoga on chronic musculoskeletal pain in AD. 
However, multiple reviews have defined the effects of yoga on musculoskeletal pain in other 
populations. A 2013 metanalysis of yoga for any type of pain (e.g., back pain, rheumatoid 
arthritis, migraine/headache) concluded all 16 studies demonstrated positive effects for pain, 
with an overall moderate effect size (46). In a “review of systematic reviews,” McCall et al. 
examined thirteen systematic reviews of yoga for treating acute and chronic conditions (47). 
Chronic pain was one of only three conditions that clearly benefitted from yoga (anxiety and 
depression also benefited). Authors concluded that yoga had a consistently positive effect on 
pain, with a moderate effect size (mean ± 95% CI) of 0.74 ± 0.52 - 0.97 that was slightly lower 
for fibromyalgia-like pain, (0.54 ± 0.11 - 0.96). 
AD patients have many health problems including sleep disorders, functional impairment, 
depression, and cognitive decline (32). It is reasonable to ask if yoga can treat these problems. 
Certainly, yoga has shown clear benefits in non-AD populations, including reductions in anxiety 
(48) depression (49), and improvements in sleep (50). Of particular relevance is the finding that 
yoga improves cognition in healthy adults, including attention and processing speed, executive 
function, and memory (51). These findings raise the exciting possibility that yoga could have 
beneficial effects for cognition in AD patients. A recent review on yoga as an 
intervention for mild cognitive impairment, or dementia (4) suggests this was the case, especially 
for attention and verbal memory, and may be mediated by improved sleep and mood. The review 
concludes that providers should consider yoga as a safe and potentially beneficial health 
approach for AD. 
Caregiver stress is becoming increasingly recognized. Dementia caregiving is associated 
with increased levels of depression, anxiety, higher use of psychoactive medications; worse 
physical health and immune function; and an increased mortality rate (52, 53). Thus, yoga 
treatment for AD patients could also prove useful for their caregivers. Indeed, the suggestion has 
been made that physical therapeutic recreation programs for dementia patients should be 
designed to serve both the patient and their caregiver (6). By performing therapy yoga could help 
reduce caregiver depression and anxiety and help guide and motivate AD patients to practice 
during non-class days. 
Interventions such as yoga pose greater demands on time and travel than many 
conventional medical treatments, making it especially difficult for individuals who have AD, 
chronic pain and/or live in remote areas. As part of a VA initiative to investigate the geographic, 
clinical, and social barriers to accessing in-person care, detailed information was collected on 
barriers to accessing healthcare from 1,295 veterans (unpublished data) (54). Results show that 
barriers included travel time and costs, health conditions, and bad weather. As a result, 
many individuals may not be able to attend in-person yoga classes. Possible behavioral and 
social problems in AD may discourage the caregiver from bringing AD patients to group classes, 
thus compounding problems of access. 
Home-based yoga is a very attractive solution to address problem of access. The 
successful implementation of teleyoga could advance and elevate the treatment of AD and 

caregivers. To date, only two small studies have examined the feasibility of at-home teleyoga 
involving patients with COPD (55) or cancer (56). Both studies reported negative experiences 
with the technology, and both concluded that internet-based yoga could be feasible if the 
technology was simplified. 
 
Objectives 
 
Specific Aims and Hypothesis 
 
Specific Aims:  
1. Modify an existing teleyoga intervention to use with AD patients and their caregivers and 
address the technical challenges of at-home teleyoga. 
2. Demonstrate the feasibility of conducting group teleyoga with AD patients and their 
caregivers. 
 
Hypothesis 1 (primary): It will be feasible to maintain an a priori adherence to > 75% classes.  
Hypothesis 2 (secondary): Treatment satisfaction as measured by the Multi-Dimensional 
Treatment Satisfaction Measure will be neutral or positive for all factors.  
 
 
Study Design  
No randomization into treatment groups will be needed in this study. The study involves 
the development of the technical methods and yoga protocol design needed to deliver at-home 
yoga instruction via videoconferencing.  
Recruitment: 15 dyads (pairs of Alzheimer’s disease patients and their caregivers) with 
chronic musculoskeletal pain will be recruited through different streams such as flyers posted at 
Stanford Alzheimer’s Disease Research Center, and VAPAHCS Pain Clinic. We may also ask 
VA providers to refer their patients with chronic pain, contacting organization that provide 
guidance and support for people with Alzheimer’s disease or chronic pain, web-based 
advertising, local advertising, social media advertising (Facebook, Twitter and Instagram using 
Web Based Recruitment Text, and mass-mailings to potential participants who may meet study 
eligibility criteria. To recruit AD patients, we may also use Brain Health Registry, which is a 
web-based platform run by UCSF to match patients with AD with suitable clinical trials 
(https://www.brainhealthregistry.org/for-investigators). The BHR will send our study 
information to interested prospective participants. These materials are attached to Tab 16 and 
include a BHR study description, BHR initial email invitation, BHR first follow-up email, and 
BHR second follow-up email. 
Individual sessions: Yoga will be first be provided individually. That is, yoga sessions 
will include the yoga therapist, one AD patient and one caregiver. We will recruit n=5 dyads (5 
AD patients, 5 caregivers).  
Group sessions: The study will also demonstrate the feasibility of providing group yoga. 
Feasibility will be measured for recruitment, retention, and adherence. We will recruit n=10 
dyads (10 AD patients, 10 caregivers). When the required number of participants have been 
identified, the study team will schedule baseline assessments. After the baseline assessment, the 
cohort will receive group yoga. We currently estimate that due to technical limitations of 

instructing yoga via videoconferencing, the largest group size will be 10 participants. Since this 
is a feasibility study, the study is not powered for efficacy.  
Yoga Intervention: We will adapt the yoga protocol from the active award. The protocol 
is 12 weeks in duration, 1 class/week, class length of 75 minutes, with additional homework 15-
20 mins on 5 non-class days/week. The protocol uses seated/standing/supine yoga postures, 
breathing, and meditation, and contains standard modifications in cases of limited mobility. 
Participants will also receive a homework manual describing simple and safe exercises to 
practice for homework. 
The sample size (n=15) is small, but will provide the necessary information on 
recruitment, adherence, acceptability and self-report measures of pain and pain-related function 
to plan a larger fully powered efficacy study in the future. Developing a yoga intervention for 
groups is typical of yoga interventions, as it allows a small staff to treat many individuals 
simultaneously.  
The main purpose of this study is to collect information on various aspects of feasibility 
and not efficacy of treatment, therefore we contend that a priori matching or a priori stratification 
is not relevant in this case. We have also considered another challenging feature of the design; 
caregivers and AD patients will interact. Participants may also interact with one another directly 
in their groups. This interaction creates the expectation that some level of intraclass correlation 
(ICC) will develop such that AD patient and caregiver responses to treatment will be positively 
correlated. The magnitude of the ICC depends on the type, duration, and intensity of these 
interactions, and are currently unknown. That ICC may be negligible at baseline, but it can 
develop over the course of the trial. We contend that with a limited number of treatment cohorts 
(2), and the limited number of yoga teachers (1-2) we have very limited ability to estimate the 
ICC, or the component of variance associated with the group or yoga teacher. Again, the main 
purpose of this study is to collect information on various aspects of feasibility and ICC is of 
negligible importance in our design, and a priori matching or a priori stratification is not 
necessary in this case. 
 
Month 
 
 
 
 
 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Recruit AD & 
Caregiver (n=5 
pairs) 
Treat AD & 
Caregivers one-on-
one format 
Treat AD & 
Caregivers group 
format  
Data analysis, 
manuscript 
submission and 
funding 
application  
 
Run AD & Caregiver 
pairs (n=10 pairs)  
 
 
 
Table 1. Recruitment Table 
 
Statistical Plan and Data Analysis  
 
The main analytic strategy will be descriptive statistics for pre- and post-intervention 
assessments for AD patients and their caregivers. For feasibility of retention and adherence, we 
aim to reach at least 65% retention. For feasibility of treatment fidelity, we will aim for ≥95% of 
treatment components. For the outcomes that will be measured repeatedly (i.e., both at baseline 

and post-treatment), we will estimate how they change over time (pre to post). Note that some of 
the assessment measures used are used only for AD patients or caregivers. The results will be 
reported for both groups separately. Accordingly, in terms of AD patient outcomes, we will 
estimate changes in pain (DVPRS), depression (BDI-II), sleep (PSQI) and cognition (CanTab). 
These results will provide preliminary data on target engagement and therefore will inform and 
shape the future trial in terms of elucidating the mechanism of action. For the caregiver 
measures, we will estimate changes in caregiver burden (Revised Memory and Behavior 
Problems Checklist), quality of life (SF-36), depression (BDI-II), and sleep (PSQI). We will also 
explore the relationship between changes in patient outcomes and their caregiver outcomes. For 
all analyses regarding changes in outcomes, we will first employ simple paired t-test (pre vs. 
post) given the correlation between pre and post measures. We will also estimate changes based 
on longitudinal mixed effects modeling using maximum likelihood estimation. We will put in 
rigorous effort to minimize missing data. Nonetheless, we expect some attrition by post 
intervention assessment. In our mixed effects modeling, data points that are missing due to 
attrition or missing assessment will be handled assuming that data are missing at random 
conditional on observed information. In all statistical analyses, we will focus on collecting 
preliminary data on clinical significance (i.e., effect size) instead of making formal inference 
(i.e., p-value). 
 
Inclusion/Exclusion Criteria  
 
Inclusion Criteria for AD patients (As determined by): 
• 
Diagnosis of probable Alzheimer's disease- Baseline 
• 
Mini-Mental State Examination (MMSE) score 18-25 (Mild AD) (screening interview) ≥ 
18 years old 
• 
Has a primary care provider who can provide medical clearance for participation in the 
study 
• 
Diagnosis of chronic musculoskeletal pain > 6 months 
• 
Minimum pain intensity at screening visit: pain rated ≥4 on a 0-10 Numeric Rating Scale 
(NRS) 
• 
Not begun new pain treatments or medications in the past month 
• 
If on a psychotropic medication regimen: stable regimen for at least 4 weeks prior to 
entry to the study; willingness to remain on a stable regimen during the 12-week acute 
treatment phase 
• 
English literacy 
• 
Wireless internet connection at home (Screening interview) 
• 
Has a caregiver who is willing to accompany AD patient for treatment, and who can 
receive yoga treatment at the same time as AD patient. 
 
Exclusion Criteria for AD patients (As determined by): 
• 
Participation in another concurrent clinical trial 
• 
Back surgery within the last 12 months 

• 
Back pain potentially attributed to a specific underlying cause, disease, or condition (VA 
EMR; screening interview) 
• 
Baseline pain <4 or ≥9 on a 0-10 Numeric Rating Scale (NRS) 
 
Inclusion Criteria for CAREGIVERS of AD patients (As determined by): 
• 
Are caring for a patient diagnosed with AD who will practice yoga together with them 
• 
Has a primary care provider who can provide medical clearance for participation in the 
study (Yoga Medical Clearance Form) 
• 
Exclusion Criteria for Caregiver 
• 
Participation in another concurrent clinical trial 
• 
Attended or practiced yoga ≥ 1 x in the past 12 months 
• 
Attended or practiced yoga ≥ 1 x in the past 12 months 
 
 
Informed Consent Process 
 
Participants will be recruited from four sources: Brain Health Registry, the VAPAHCS 
Pain Clinic, local advertising, and web-based advertising. These sources will result in either 1) 
the potential participant calling the study team or 2) with the participant’s consent, the study staff 
contacting them directly. Study candidates will be invited to VAPAHCS for a screening visit, 
during which the Project Manager will obtain informed consent and review the Health Insurance 
Portability & Accountability Act (HIPAA) document.  
The informed consent process will involve the AD patient and their caregiver together. 
They will complete separate consent forms. As we are enrolling AD patients with impaired 
consent capacity, the caregiver will act as a legal authorized representative (LAR) and provide 
consent for the AD patient, who will be asked to provide their assent. These forms will include 
the HIPAA document and are estimated to take about 60-90 minutes. It will take place in a quiet 
office or interview room, located in the same building as the PI, who will be available to answer 
any of the study candidate’s questions. 
 
1. The Project Manager will explain the information contained in the written informed 
consent forms (purpose, procedures, risks, benefits, alternatives to participation, etc.) and 
HIPAA documents to the study candidates verbally, in lay language. 
a. The Project Manager will check for comprehension, allow the study candidates 
ample opportunity to ask questions throughout the process, and repeat the 
information, as necessary. 
b. Care will be taken to inform the study candidate that their participation is entirely 
voluntary, and they may withdraw at any time and for any reason without penalty 
or loss of benefits to which they would otherwise be entitled. 
c. Study candidates will then be asked to carefully read the informed consent form 
to consider whether or not to participate in the research and to ask questions. 

d. To ensure that the study candidate understands the research, they will next be 
asked to summarize the consent form and HIPAA addendum, with a special focus 
on the discomforts, risks, benefits, and confidentiality sections. 
2. If the study candidate demonstrates (by stating in his/her own words) an understanding of 
the purpose, risks, and benefits of the study and agrees to participate in the study, he/she 
will be asked to initial each page, in addition to sign and date the last page of the consent 
form and the HIPAA document. 
3. The Project Manager who oriented and obtained informed consent will sign and date the 
informed consent form. 
4. The Project Manager will provide each enrolled participant with a photocopy of the 
original signed copy and keep the original signed copy in a binder in a locked cabinet. 
 
The emphasis on the voluntary nature of participation is designed to minimize the 
possibility of coercion or undue influence on participation. The study candidate will be given 
time to understand the written informed consent form and make an informed decision. All 
treatments for this study will be provided in group formats, so potential participants will be 
reminded that full anonymity cannot be maintained. Following the informed consent process, the 
enrolled participant will complete other measures (See Research Strategy). 
 
Screening Procedures  
Potential participants (n=15) will be screened via phone. The Project Manager will obtain 
informed consent and review the Health Insurance Portability & Accountability Act (HIPAA) 
document. After obtaining informed consent, a trained researcher will collect demographic 
information (Demographic Questionnaire). Screening for protocol eligibility for AD participants 
will include the MMSE, PEG, DVPRS and Clinical DVPRS. 
 
Study Assessments 
 
Demographics Questionnaire: Documents age, gender, education, and race/ethnicity. 
Clinical Questionnaire: Self-report document focusing on the existence of 78 health symptoms 
taken from a list of ICD-9 codes that are highly likely to represent chronic pain. 
Medication Use: Self-report of all current pharmacological and non-pharmacological treatments. 
Yoga Home Practice Log: Log for participant to document their yoga home practice on non-
treatment days. 
BDI-II Beck Depression Inventory-II (BDI-II): Contains 21 self-report questions, scored on a 
0-3 scale, related over the past two weeks to sleep, appetite, punishment, suicide, and interest in 
sex. 
Brief Pain Inventory-Short Form (BPI-SF): Assesses intensity and impact of pain on 
functioning on a 0-10 rating scale. Interference is assessed on daily life (general, walking, work, 
mood, enjoyment, relationships, sleep). The BPI is recommended by the Initiative on Methods, 
Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group for inclusion in 
clinical trials evaluating pain. 
Defense and Veterans Pain Rating Scale (DVPRS): A five-item scale: one 0-10 pain intensity 
numeric rating scale and four supplemental items measuring functional outcomes (general 
activity, sleep, mood, level of stress). The pain intensity scale is designed to improve upon 

existing scales by using visual cues and word descriptors to anchor pain ratings with perceptual 
experiences and limitations imposed by pain. 
PEG: A 3-item pain measure derived from the Brief Pain Inventory and validated in ambulatory 
care settings. It includes 1 severity item (average pain) and 2 interference items (enjoyment of 
life and general activity). 
Pittsburg Sleep Quality Index (PSQI) (62): Contains 10 self-report questions regarding sleep 
habits over the past month, including discrete responses (e.g. amount of sleep) and responses 
scored on a 0-3 scale (“not during the past month” to “three or more times per week”), related to 
sleep quality, medication use, motivation, and fatigue. A global sum score indicates level of 
sleep difficulties. 
Treatment Satisfaction: Assessed using the Multi-Dimensional Treatment Satisfaction Measure 
(MDTSM). The measure consists of 11 subscales assessing treatment process and outcome 
attributes. Each subscale has 1-8 items (see Table 5). Each question except the Discomfort 
subscale is rated on a five-point scale ranging from “not at all (0)” to “very much (4)”. Thus, a 
score of 2 represents a rating of neutral satisfaction. The instrument was developed for 
behavioral interventions and is designed to provide a comprehensive set of treatment attributes to 
consider when evaluating treatments in the context of pilot studies. It is designed to be completed 
after exposure to an intervention, to point to aspects of treatments that are viewed favorably or 
unfavorably. The MDTSM is relevant to many types of behavioral interventions and 
can be tailored to our yoga intervention. The MDTSM subscales demonstrates good internal 
consistency, reliability, and validity.  
Treatment Fidelity: Of the 12 sessions recorded, we will randomly select a session from weeks 
1-4, weeks 5-8, and weeks 9-12 for a yoga instructor to review. Following standard procedures 
(64), they will review the sessions using a manual checklist for instructor adherence to the yoga 
manuals, which will consist of a Yes/No prompt for each procedure or instruction. We will set a 
benchmark for minimum competency at ≥95% of treatment components (64). 
Cambridge Neuropsychological Test Automated Battery (CANTAB): Cognitive function 
was measured with the Cambridge Neuropsychological Test Automated Battery (CANTAB) at 
baseline and end of treatment. Three tests were administered (PAL, SWM and RVP).  
Revised Memory and Behavior Problems Checklist (RMBPC) (68): Assesses behavior 
problems in dementia patients. Contains 24 caregiver-report questions, scored on two scales; 
whether the behavior was observed (“yes”/”no”), and the degree it affected the caregiver. Scales 
yield scores; one total score for patient problems and three subscale scores (memory-related, 
depression, and disruptive behaviors), and parallel scores for caregiver reaction. 
SF-36: Health related quality of life-short form (69). Eight scales measuring physical 
functioning, role limitations due to physical problems, bodily pain, general health perceptions, 
vitality, social functioning, role limitations due to emotional problems, and mental health. 
 
 
Data Collection  
 
Screening 
Baseline 
Yoga (wks 1-
12) 
Post-treatment 
Background 
 
 
 
 
Consent Form 
˟ 
 
 
 
Demographic Questionnaire  
˟ 
 
 
 
Clinical Questionnaire  
˟ 
 
 
 
Yoga Medical Clearance Form 
˟ 
 
 
 

 
Table 2. Study Measures and Timetable of Data Collection  
 
Medical Use  
 
˟ 
 
˟ 
Yoga Home Practice Log 
 
 
˟ 
 
Mental Health  
 
 
 
 
BDI-II 
 
˟ 
 
˟ 
Pain/QOL/Physical 
 
 
 
 
BPI-SF 
 
˟ 
 
˟ 
DVPRS 
˟ 
 
 
 
PEG 
˟ 
˟ 
 
˟ 
PROMIS-PI 
 
˟ 
 
˟ 
Behavioral  
 
 
 
 
Treatment Satisfaction 
 
 
 
˟ 
Provider Suggestions 
 
 
 
˟ 
Patient Safety  
 
 
˟ 
˟ 
Treatment Fidelity  
 
 
˟ 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
IRB Use Only 
Approval Date:  September 10, 2020 
Expiration Date: (Does not Expire) 
 
What is this research about? 
 
You are invited to participate in a research study to test whether it is feasible to use 
telehealth to deliver yoga as a treatment for chronic pain for people with Alzheimer’s 
disease. Our goal is to modify an existing yoga protocol for musculoskeletal pain and to 
address the technical challenges of at-home teleyoga. You were selected as a possible 
participant in this study because you have indicated that you have been experiencing 
chronic pain and have a diagnosis of Alzheimer’s disease OR you care for a person with 
Alzheimer’s disease that experiences chronic pain. This research study is looking for 15 
who exhibit symptoms of chronic pain and want to use yoga via telehealth to treat their pain 
OR caregivers who want to support the Alzheimer’s patient they care for and that exhibits 
symptoms of chronic pain to use yoga via telehealth to treat their pain.  
 
This study is being done by researchers at VA Palo Alto Health Care System and Stanford 
University and is sponsored by the National Center for Complementary and Integrative 
Health. 
 
What is expected of me? (Procedures)  
 
Baseline (2-3 hours): You will be asked to complete self-report questionnaires about your 
medication use, your experience of chronic pain, your sleep and mood, on the phone or 
online through Qualtrics or REDCap. People with Alzheimer’s disease will also be given a 
brief cognitive test. Caregivers will be given an additional questionnaire on their experience 
of caregiving. During this session we will record your phone number, the physical location 
for at-home teleyoga and an emergency contact. This information will be used if video 
disconnects or an unforeseen emergency arises during at-home teleyoga. 
Treatment (12 weeks): In the first week, you will be given a yoga mat, yoga strap, and 
yoga blocks for use during the yoga class that you will be attending. You will be given 
instructions on how you can watch and participate in the yoga classes at home via video 
conferencing. You will determine a part of the home that is most comfortable and 
appropriate for a yoga class. You will participate in 1 yoga class per week for 12 consecutive 
weeks, 75 minutes per class, at a time that is convenient for you, the teacher, or the group. 
A member of the study staff will call you the business day before class to remind you of the 
class and to charge the iPad for class. The yoga instructor will be offering a live yoga class, 
and you will participate at home using the provided iPad to watch the yoga class via video 
conferencing alongside your caregiver or the person you care for.    

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
IRB Use Only 
Approval Date:  September 10, 2020 
Expiration Date: (Does not Expire) 
Post-Treatment (2-3 hours): You will be asked to complete the same self-report 
questionnaires you were given before treatment and asked to provide feedback about the 
program, including any technical issues you encountered. This will be done either in-person 
at the VA Palo Alto, on the phone or online through REDCap or Qualtrics. You will mail the 
iPad back to study staff via USPS.   
Video Recording: Video recording will be used to monitor fidelity of treatment delivery. 
Recordings will be made of treatment providers, not the participants. Recordings will be 
stored on a secure server in accordance with IRB guidelines. Record retention polices 
require records, including videos, created during a research project to be maintained for 6 
years after study closure, wherein they will be destroyed.  
What are the possible risks or discomforts? 
 
The risks associated with this study are minimal. The yoga protocol is developed for people 
with chronic pain and those without pain. As a caregiver you will be encouraged to move 
safely and modify postures as necessary in a way that is most comfortable for you. If there 
is an unforeseen emergency during your at-home teleyoga session, we will take the 
necessary steps to ensure medical help arrives to the address you provided at the start of 
the study, for yourself or the patient.  
 
Will I benefit from the study? 
 
The benefits which may reasonably be expected to result from this study are relief from 
chronic pain if you experience it or general relaxation associated with yoga. 
 
What are my alternatives to being in this study? 
 
You may choose not to participate in this study. If this is your decision, there are other 
choices including standard treatments provided by a local clinic if you experience pain. The 
study investigator will discuss any alternatives before you agree to participate in this study. 
Alternative treatments if you are experiencing pain include medication and behavioral 
therapy.  
 
Will I get paid? 
 
You will receive $200 as payment for your participation. Payments may only be made to 
U.S. citizens, legal resident aliens, and those who have a work eligible visa. You may need 
to provide your social security number to receive payment. 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
IRB Use Only 
Approval Date:  September 10, 2020 
Expiration Date: (Does not Expire) 
Will I have to pay anything?  
 
You will not have to pay anything to be in this study.  
 
Do I have to be in this study? 
 
Your participation in this study is entirely voluntary. Your decision not to participate will not 
have any negative effect on you or your medical care.  
 
Can I change my mind later and stop being in this study? 
 
You can decide to participate now, but you may withdraw your consent later and stop being 
in the study without any loss of benefits or medical care you are entitled to. The Protocol 
Director may also withdraw you from the study without your consent for one or more of the 
following reasons: 
• Failure to follow the instructions of the Protocol Director and study staff. 
• The Protocol Director decides that continuing your participation could be harmful to 
you. 
• Pregnancy  
• You need treatment not allowed in the study. 
• The study is cancelled.  
• Other administrative reasons. 
• Unanticipated circumstances. 
 
Will my information be protected from the public? 
 
We will keep your name and all the information you tell us in this study as confidential as 
possible. We may publish the results of this study for others to read about, but you will not 
be identified in any articles about the study by name, social security number, address, 
telephone number, or any other direct personal identifier. Also, other federal agencies as 
required, such as the VA Office of Research Oversight and the VA Office of the Inspector 
General may have access to your information.   
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, 
documents, or biospecimens that may identify you in any federal, state, or local civil, 
criminal, administrative, legislative, or other action, suit, or proceeding, or be used as 
evidence, for example, if there is a court subpoena, unless you have consented for this 
use. Information, documents, or biospecimens protected by this Certificate cannot be 
disclosed to anyone else who is not connected with the research except, if there is a federal, 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
IRB Use Only 
Approval Date:  September 10, 2020 
Expiration Date: (Does not Expire) 
state, or local law that requires disclosure (such as to report child abuse or communicable 
diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings, see below); if you have consented to the disclosure, including for your medical 
treatment; or if it is used for other scientific research, as allowed by federal regulations 
protecting research subjects. The Certificate of Confidentiality will not be used to prevent 
disclosure as required by federal, state, or local law of harm to self or others. The Certificate 
of Confidentiality will not be used to prevent disclosure for any purpose you have consented 
to in this informed consent document, including research information in the medical record. 
 
 
What happens if I think I’ve been hurt by being in this study? Who can I talk to about 
a Research Related Injury? 
 
If you are injured as a direct result of being in this study, medical treatment will be available. 
If you are eligible for veteran’s benefits, the cost of such treatment will be covered by the 
VA. If not, the cost of such treatments may still be covered by the VA depending on a 
number of factors. In most circumstances, the treatment must be provided in a VA medical 
facility. No other form of compensation for injuries is available. However, by signing this 
form you have not released the VA from liability for negligence. For further information, you 
may call the Human Protections Administrator at (650) 493-5000, ext. 67593 or the V.A. 
Regional Counsel at (415) 750-2288. 
 
 
Who can I talk to if I have questions about the research, problems related to the study 
or if I think I’ve been hurt by being a part of the study? 
 
If you have any questions, concerns or complaints about this research study, its 
procedures, risks and benefits, or alternative courses of treatment, you should ask the 
principal investigator, Dr. Peter Bayley (650) 493-5000 ext. 68653. You should also contact 
him at any time if you feel you have been hurt by being a part of this study.  
 
If you are not satisfied with how this study is being conducted, or if you have any concerns, 
complaints, or general questions about the research, your rights as a participant or those 
of the patient you care for, and would like to speak someone independent of the research 
team please contact the Stanford Institutional Review Board (IRB) at (650)-723-5244 or toll 
free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 3000 
El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306. 
 
Please print or save a copy of this page for your records 
 

 
 
 
RESEARCH CONSENT FORM 
Title of Study: Feasibility of At Home Telehealth Yoga for Treating Chronic Pain 
 
Title of Consent (if different from Study Title):  
Principal Investigator: Peter J. Bayley, Ph.D. 
VAMC: 
VA Palo Alto HCS 
 
IRB Use Only 
Approval Date:  September 10, 2020 
Expiration Date: (Does not Expire) 
If you agree to participate in this research, please indicate this to the researchers and 
complete the following survey.