Telehealth Cognitive-Behavioral Therapy for Depression in Parkinson's Disease
Phase: NA
Conditions: Depression, Parkinson's Disease
Sponsor: VA Office of Research and Development

Protocol 6/18/15 
1 
Telehealth Cognitive Behavioral Therapy for Depression 
in Parkinson's Disease (PD) 
ClinicalTrials.gov ID: NCT02475954 
Document Date: 6/18/15 

Protocol 6/18/15 
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Title of Project: Telehealth Cognitive Behavioral Therapy for Depression in Parkinson's Disease (PD) 
Principal Investigator: Alejandro Interian, Ph.D. 
Funding Source(s): VA HSR&D
1. Purpose/Specific Aims
There is a critical need for treatments that address depression and barriers to mental health care among
the nearly 100,000 Veterans with Parkinson’s disease (PD) served by the VA. Depression in PD (dPD) is a
major complicating factor in the movement disorder, affecting several key functional outcomes such as
motor disability, cognitive status, quality of life, and Care-partner relationships.1-4 The challenge to
meeting the treatment needs of Veterans with dPD centers on the lack of clinicians who are
knowledgeable about the interactions of PD and depression, the considerable transportation barriers
faced by this population, combined with the geographical dispersion of specialized services within the
VA, and the paucity of effectiveness research that informs treatments for dPD. 5
To address this problem, we propose to conduct a randomized controlled trial (RCT) to test the 
effectiveness of a psychotherapeutic intervention aimed at treating depression in Parkinson’s disease 
(dPD) in Veterans. The proposed study treatment consists of a 10-session cognitive-behavioral 
treatment (CBT) package that has been tailored to address the unique needs of depressed Veterans with 
PD. Also, the treatment seeks to overcome treatment access barriers by a using telehealth delivery 
platform (i.e., video-to-home telehealth technology). In addition, the proposed treatment package 
provides support and skills-training to the Veteran’s Care-partner (3 sessions).  
1.1 Objectives 
AIM 1: To evaluate the effectiveness of TH-CBT (telehealth-cognitive behavioral therapy) for improving 
Veteran outcomes in dPD (depression in Parkinson's Disease).  
AIM 2: To examine the impact of TH-CBT for dPD on a variety of Care-partner outcomes. 
AIM 3: To assess Veteran and Care-partner perspectives on TH-CBT using qualitative, semi-structured 
interviews. 
1.2 Hypotheses 
Primary Hypotheses:  Depressive symptoms will decrease more for Veterans receiving TH-CBT (the 
“intervention group”), than for Veterans receiving standard care only (the “control group”). 
Secondary Hypotheses:  There will be more treatment responders in the TH-CBT group (the 
“intervention group”) than in the standard care group (the “control group).” Psychiatric and functional 
correlates of dPD for Veterans receiving TH-CBT will show greater improvement (anxiety, quality of life) 
or stabilization (motor disability) over time than those for Veterans in the standard care group. 
Care-partner Hypotheses:  Care-partners in the TH-CBT condition(the “intervention group”) will feel 
more empowered, report less distress and be less critical (towards the Veteran) relative to Care-
partners in the standard care group (the “control group”). 

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2. Background and Significance 
 
Depression, the most common non-motor complaint in PD, 1 affects up to 50% of PD patients.6 
Depression in PD (dPD) is associated with rapid physical and cognitive decline,2 poorer quality of life,7 
increased healthcare costs,8  earlier initiation of dopaminergic replacement,9 and notable Care-partner 
distress.3 Depression is therefore a key intervention target for improving a range of PD complications. 
 
Yet, unfortunately, depression treatment is the one quality standard inadequately addressed in VA PD 
care, including in its PD specialty centers.10,11 Sub-optimally treated dPD aggravates physical and 
cognitive PD morbidity, thereby undermining all of the VA’s other evidence-based efforts to improve 
non-mental health disturbances for PD Veterans.2,10,12 Thus, there is a critical need for treatments that 
address depression and barriers to care among the approximately 100,000 Veterans with PD.13 
 
The challenge to addressing depression in PD centers on the lack of mental health clinicians who are 
knowledgeable about the movement disorder (a prerequisite to effective care), the transportation 
barriers faced by Veterans, the geographical dispersion of VA services, and the paucity of effectiveness 
research that informs depression treatments for PD Veterans.5 
 
The proposed study seeks to overcome these obstacles by using a telehealth delivery platform (i.e., 
video-to-home; “V2H” or “CVT-H”) to test the effectiveness of a 10-session cognitive-behavioral 
treatment (CBT) package, tailored to address the unique needs of Veterans with dPD.  Preliminary 
studies provide strong support for the current trial. V2H allows Veterans to use their computer’s 
webcam to interact with their providers using videoconferencing, via the VA’s secure telehealth 
connection.  
 
The current trial builds on several earlier trials that have shown support for this intervention to treat 
depression in PD.  
 
First, this CBT package was initially tested in a face-to-face RCT with 80 people with dPD (and Care-
partners), who were randomized to receive CBT plus standard care or standard care only for 10 weeks. 
The Hamilton Depression Rating Scale 14 (HAM-D 17) was the primary outcome. Treatment response was 
defined a priori as a rating of a 1 or 2 on the Clinical Global Impression-Improvement Scale 15 (CGI-I; a 7 
point scale with scores ranging from 1 [very much improved] to 7 [very much worse] ) or ≥50% reduction 
in the baseline HAM-D 17 score. Patients were evaluated at baseline, midpoint (week 5), endpoint (week 
10), and one-month follow-up (week 14). CBT was associated with greater improvements in depression, 
[HAM-D 17; F(3,215)=30.74 P<.0001; Cohen’s d=1.59] & Beck Depression Inventory (BDI) F(3,210)=9.77 
P=.001; Cohen’s d=1.10], anxiety [F(3,214)=11.65 P=.001; Cohen’s d=.98], quality of life [F(3,209)=5.07 
P=.02, Cohen’s d=.81], coping [F(3,204)=4.25, P=.05; Cohen’s d=.80] , and motor disability [F(1,68)=5.9 
P=.02; Cohen’s d=.13] vs. control. At week 10, 56% patients receiving CBT and 8% receiving standard 
care were treatment responders,  as defined above (Fisher's exact P<.0001). At week 14, 51% of CBT 
patients and 0% of patients in the standard group met criteria for response (Fisher's exact P <.0001).  
 
Second, this treatment was repeated in an uncontrolled trial, where the intervention was delivered via 
telephone. Within group CBT effect sizes for telephone delivery showed a similar treatment effect, 
compared to effect sizes obtained via face-to-face delivery. This telephone-based CBT protocol was 
provided to 21 patients and Care-partners, resulting in significant improvements in depression [HAM-D 

Protocol 6/18/15  
              
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17: F (3,56)=18.50, P<.0001; Cohen’s d=1.21 and BDI: F(3,53)=23.68, P<.0001]. This trial demonstrated 
that the same treatment can be delivered remotely with a similar level of treatment impact.  
 
Combined, these initial studies provide support for the CBT package and for its remote delivery (i.e., 
telehealth). The current trial therefore proposed to test the delivery of this treatment via video-to-home 
telehealth. This modality of care has been rolled out by the VHA and therefore provides an existing 
infrastructure to make this intervention available to Veterans with dPD, who face access barriers to 
treatment. For example, at VA New Jersey, 583 mental health encounters have been conducted via 
video-to-home telehealth in FY14.  
 
3. Research Design and Methods 
 
Participants will include 90 Veterans (ages 35-85) with dPD and their Care-partners (N=180 total: 90 
Veterans with PD and 90 Care-partners). Since Care-partners will be designated by their Veteran with 
PD, they will not likely be Veterans themselves. The justification for including nonveterans is due to the 
fact that Care-partners serve as an integral part of the treatment team for Veterans with dPD. Thus, we 
are evaluating the clinical effectiveness of an intervention that involves Care-partners in order to 
optimize Veteran depression treatment response and Care-partner well-being. 
 
The clinical effectiveness of a 10-session telehealth-based cognitive-behavioral treatment package (TH-
CBT) for dPD will be evaluated. Study conditions are as follows:  
• 
[Intervention] Half of the Veterans will receive telehealth-based CBT, in addition to their 
standard care (i.e., treatment-as-usual under the care of their personal physicians).  
• 
[Control] The other half will receive their standard care only during the study period.  
Participants will be randomly assigned to treatment group via computer generated random 
assignment. Randomization will be stratified by antidepressant use at baseline (yes/no). 
 
Veterans will be evaluated remotely, via telephone, prior to treatment (week 0), mid-way through 
treatment (week 5), immediately after treatment (week 10), one month following treatment, and six 
months following treatment by raters who are blind to treatment condition. A purposive subsample of 
40 treatment recipients (20 Veterans/20  Care-partners; will receive a semi-structured interview (i.e., 
exit interview) at Week 10, in order to generate qualitative data on their experience with the study. 
Specifically, these interviews will focus on 10 Veterans (and their Care-partner) who respond at 
endpoint (i.e., CGI-I of 1 or 2) and 10 (and their Care-partner) who do not respond (i.e. CGI-I of 4 or 5) to 
TH-CBT. 
 
 
Participants will receive the study treatment at no cost. Veterans and Care-partners will each receive 
$45 per outcome assessment completed. Data collection ends for all participants at the 6-month follow-
up. However, since we expect that our Veteran population will not have access to a needed tailored 
psychotherapy for dPD (TH-CBT), we will offer this clinical care to control group participants, after the 
data collection period. However, no additional data will be collected. The total duration of the protocol 
is9 months for all participants.  
 
3.1. Duration of Study 
 
This is a four-year study that will actively recruit subjects for a period of approximately 3.5 years.  
Subjects enrolled in the study will participate in the protocol for approximately 9 months.  

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3.2 Study Sites 
 
Subjects will be Veterans of VA New Jersey Healthcare System. VA New Jersey will be the only site 
engaged in Human subjects research.  
 
3.3 Sample Size Justification & Subject Selection 
 
The study will enroll a total of 180 subjects (90 Veterans + 90 of their Care-partners), from VA New 
Jersey, who have Parkinson’s Disease and depression. 1,199 Veterans with dPD were served in VA New 
Jersey during the last four fiscal years. Several methods of recruitment (see Recruitment and Consent 
below) will be used to enroll this pool of Veterans.  
 
Our Power Analyses assume 180 participants (90 enrolled dyads) with 144 participants (72 dyads, 36 
dyads each arm), completing the study. Observed standard deviations in the power calculations that 
follow are taken from control group baseline data in Dobkin et al.16 For the primary test of treatment 
differences in HAM-D scores, controlling for baseline HAM-D scores and demographic covariates, the 
current study is powered to detect a 2.5 point HAM-D treatment difference between groups. For 
comparison, we observed a group difference of 7.30 in Dobkin et al.16 For the secondary test of 
responder/nonresponder, we considered clinical response rates of 0.05 and 0.10 for the control group 
and .35, .40, and .45 for the treatment group. Power was greater than .95 in call cases. For comparison, 
we observed rates of 0.08 and 0.56 in the control and treatment groups, respectively, in Dobkin et al. 
(2011). 
 
3.4.1 Inclusion Criteria  
 
Veteran Inclusion Criteria:  
1) Confirmed PD diagnosis in the VA medical record;  
2) Primary Major Depression, Dysthymia, or Depression NOS of at least moderate severity per the 
SCID;87  
3) Access to a computer/tablet with high-speed internet access. Comorbid anxiety disorders are 
not exclusionary if the depressive disorder is primary. 
4) Ages 35-85;  
5) Stable medication and mental health regimen (including applicable antidepressants, other 
psychotropic agents, movement disorder drugs, clinic-based psychotherapies) ≥ 6 weeks). This 
means that the medication regimen and treatment plan have been consistent for at least 6 
weeks.  
6) Family member or friend willing to participate;  
 
Veteran Exclusion Criteria:  
1) Possible dementia or marked cognitive impairment [Montreal Cognitive Assessment Score 
(MoCA) < 21]. 17  
2) Motor fluctuations ≥ 50% of the day;  
3) Acute suicidal plans or intent (determined by clinical interview);  
4) Unstable medical conditions;  
5) Bipolar, Psychotic Spectrum, or Substance Use Disorders.  
 

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Exclusion Criterion 1 above is due to dementia being associated with numerous clinical variables (e.g., 
motor fluctuations, delusions) that make the rating of depression difficult. Dementia may also 
compromise the clinical effectiveness of a non-pharmacological treatment due to its impact on cognitive 
processes. As dementia is not typically seen in the early stages of PD, results from the current study 
should generalize to the larger PD population without dementia. 
 
Care-partner Inclusion Criteria:  
1) Ages 25-85;  
2) Daily contact with Veteran 
Care-partner Exclusion Criteria:  
1) Unstable medical/psychiatric conditions (clinical interview). 
 
3.4.3 Subject Recruitment and Consent 
 
180 participants (90 Veterans with PD and 90 Care-partners) will be recruited from the New Jersey area 
(2 VAMCs and 9 CBOCs), using several recruitment strategies. A DSS report will be generated with 
contact information of Veterans in VANJ who had a visit with a diagnosis of PD, during the previous 4 
fiscal years (a HIPAA waiver has been submitted). Letters will be mailed informing them of the study, 
and study staff will contact them by telephone to determine if they would be interested in and eligible 
to participate. If there is no contact by the Veteran, the research team will call the Veteran after waiting 
a period of 2 weeks, unless the veteran notifies the study team that he/she does not wish to receive a 
phone call.   
Recruitment will also take place through Neurology and Primary Care Clinics at VA New Jersey. Veterans 
will be recruited from these sites via recruitment flyers (attached). Also, providers may refer potential 
candidates to the research team. This will be done by either instructing the Veteran to contact the 
research team or alerting the research team via CPRS that the Veteran is interested. In case of the latter, 
the research team will send a letter (see attached) to the potential candidate that includes the name of 
the referring provider. As above, phone contact will not be initiated earlier than two weeks and in cases 
where the Veteran notifies the study team that he/she does not wish to be contacted.  
Candidates identified with the methods described above will be informed of the study. If they are 
interested, a phone script will guide the candidate through informed consent for the phone screen (see 
attached Waiver of documentation of consent). If verbal consent is provided, they will be screened by 
telephone (see attached phone screen) for basic eligibility criteria.  For those who meet basic eligibility 
and remain interested, consent forms will be mailed to potential participants. At a later time (allowing 
for consent forms to arrive at candidate’s homes), study staff will then review the consent form with the 
potential participant over the phone. After all questions are answered, the participant will sign the 
consent form and mail it back to the study team, so that they can later be formally evaluated for study 
eligibility (i.e,. baseline evaluation). This same consent process will also be conducted for the Care-
partner. 
 
Other Procedures:  
 
Baseline Assessment:  After the screening and consent, appropriate individuals will be scheduled for a 
telephone appointment. Demographic information will be obtained, and inclusion/exclusion criteria will 

Protocol 6/18/15  
              
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be assessed. A detailed medical (i.e., number of medical conditions, duration and stage of PD) and 
psychiatric history (i.e., number past depressive episodes, past treatments), and a current list of all 
prescription and over-the-counter medications will be gathered. Clinician-administered rating scales and 
self-report measures will be completed. The screening appointment typically lasts between 2 and 3 
hours. If participants are unable to complete the entire screening evaluation in one day, a second 
telephone appointment will be scheduled within the next 7 days to complete the remainder of the 
screening procedures.  
 
Randomization: All appropriate candidates will be randomly assigned to receive either: 1) telehealth-
based cognitive-behavioral therapy plus standard care (the “intervention”) or 2) standard care, based on 
computer generated random assignment, after the screening appointment (the “control group” 
treatment). Randomization will be stratified by antidepressant medication (ADM) use at baseline (yes or 
no) such that patients taking ADMs are equally represented in both treatment conditions. Patients will 
be notified of their assignment to group via telephone in the week following their baseline assessment.  
 
Assessments: Participants will be assessed at baseline (week 0), midpoint (week 5), endpoint (week 10), 
and follow-up (1 and 6 months post-treatment). Follow-up assessments will be conducted via telephone 
for the clinician-rated instruments (i.e., HAM-D, HAM-A). Self-report questionnaires will be mailed to 
participants with a self-addressed envelope that can be returned to the research team upon completion. 
If participants request assistance with the self-report questionnaires, they will be mailed to them and 
also read aloud to them by telephone. These assessments will last 1-2 hours.   
 
Qualitative Data: Semi-structured interviews will be used to study participants’ perspectives in terms of 
treatment effectiveness. Specifically, selecting from the study’s treatment arm, quantitative data will be 
used to identify a purposive subsample of participants for qualitative interviews, where 10 Veterans 
who respond at endpoint (i.e., CGI-I of 1 or 2) and 10 who do not respond (i.e. CGI-I of 4 or 5) to TH-CBT 
will be identified. Once identified, qualitative data will consist of semi-structured interviews conducted 
separately with these Veterans and their Care-partners. A total of 40 interviews will be conducted (10 
responder Veterans + their 10 Care-partners; 10 non-responder Veterans + their 10 Care-partners). 
 
Blinding: All follow-up (i.e., post-baseline) assessments will be conducted by independent evaluators 
without knowledge of treatment condition. Veterans will be instructed not to reveal group assignment 
to raters. Veterans and therapists will not be blind given the nature of the treatment. Information 
regarding the integrity of the blind (patient revealing group assignment to rater) and the blind raters’ 
guess regarding group assignment will be collected after each study evaluation. In rare cases in which 
the blind may be broken, the interview recording (with unblinding information removed) will be 
presented to a second rater for coding. Therefore, all final score determinations will be made by an 
independent evaluator with no knowledge of group assignment. 
 
Video-to-home telehealth V2H): Inclusion criteria require that all participants will need a home 
computer or tablet with a webcam to participate in the study. If they do not have a webcam, one will be 
provided to them. V2H set up for Veterans will follow established procedures in place at VANJ, which is 
supported by the facility’s telehealth lead (Anthony Gomez). This includes signing the facility’s video-to-
home consent form and application, documenting which records are needed, including emergency 
contacts for the participant (included as an attachment). Veterans will need to download the software 
(i.e., Jabber) for connecting with the study team. They will be assisted with self-help instructions, study 
team telephone guidance, and/or a home visit, depending on the level of assistance needed with V2H 
installation procedures. 

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As documented in the VHA’s Clinical Video Telehealth in the Home Manual, prior to the initiation of 
telehealth sessions, information will be obtained pertaining to emergency contacts that can be called in 
case of emergency.  
 
 
Contact for appointments related to treatment and assessments: 
This research is being carried out with a population that requires active engagement to mental health 
services. In standard VA NJ mental health care, this is reflected in policies requiring at least three follow-
up phone calls and/or a letter after a no-show to standard mental health appointment. Our research 
team will adopt a similar approach to maintaining engagement, utilizing telephone calls and letters to 
arrange for appointments. Our philosophy will be guided by a person-centered, relationship-building 
approach. For example, we anticipate that there will be several missed appointments and our 
interactions with study participants will convey empathy and understanding for missed appointments, 
as well as flexibility and accommodation for rescheduling. On the other hand, our research staff will also 
be sensitive to indications that participants no longer wish to participate and will cease contact efforts 
once that appears to be the case.  
3.4.5 Subject Costs and Compensation 
 
There will be no cost to subjects for the study treatment sessions.  Veterans and Care-partners will each 
receive $45 per outcome assessment completed. Subjects selected for the semi-structured interviews 
will receive an additional $20.  
 
3.5 Chart Review Selection 
 
Research staff will also perform retrospective chart reviews on all enrolled study subjects for the 
purpose of documenting the standard care that participants received during the study. Standard care 
will focus on mental health standard care. Because our study occurs within the context of standard care, 
data will be collected to describe the standard care received and/or control for potential standard care 
covariates.   Specifically, we will gather detailed standard VA medical care information pertaining to: a) 
psychotropic medication use (dose, type, frequency); b) number of medication management visits; c) 
number of standard care psychotherapy visits (i.e., non-TH-CBT). Non-VA standard mental health care 
will be assessed via interview.  
 
As with our primary data, all medical records data will have identifiers removed and data storage will 
occur by ID number, rather than name. Also, the data will be stored on a secure server that is 
maintained by the VA’s IRM (Information Resource Management) and has up to date security 
protections. Within this server, the data will be placed on a secured folder (\\Vhalynclu1\dual 
diagnosis\) that is restricted for only users that are part of the VANJHCS Dual Diagnosis Unit, which is 
our local research unit. Data will also be stored in VINCI, which is the VA’s computer infrastructure that 
allows data storage, analysis, and sharing, while maintaining privacy and security.  
 
4. Study Variables 
 
 
4.1 Interventions 

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Study Conditions 
Control Group: Standard Care. Standard Care is defined as medical and psychiatric treatment provided 
by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to 
receive routine clinical care and will remain on all depression treatments that they were receiving prior 
to their study (e.g., stable ADMs, established psychotherapy, clinical monitoring). Care-partners will 
continue to receive all non-clinical services for which they qualify through the VA, including services 
offered through the Office of Caregiver Support, as well as PD caregiving resources, support groups, and 
referral information provided by the American Parkinson’s Disease Association. 
 
Intervention Group: TH-CBT + Standard Care: The TH-CBT group will receive the study intervention and 
standard care. The study treatment has been previously manualized and modified for remote 
administration. dPD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, 
delivered via V2H. Treatment will incorporate behavioral activation, exercise, thought monitoring and 
restructuring, relaxation training, worry control, and sleep hygiene (emphasis dictated by patient 
preference), and will be augmented with 3 separate Care-partner educational sessions (30-60 minutes 
each), that are evenly dispersed throughout the Veterans' treatment. The Care-partner sessions are 
intended to provide Care-partners with the skills needed to facilitate the Veterans’ practice of self-
management techniques (i.e., exercise, socializing, reframing thoughts) both between sessions and after 
treatment had ended, in order to empower the Care-partner in the helping role. The intervention will be 
provided by IRB-approved licensed clinical social workers and doctoral level clinicians under the 
supervision of Drs. Interian and Dobkin. 
 
The CBT package employed in this trial is tailored to the unique needs of the Parkinson’s population. In 
brief, PD specific modifications include a stronger emphasis on behavioral and anxiety management 
techniques than traditionally integrated into CBT protocols for depression, and the inclusion of a 
supplemental Care-partner educational program. These changes have been successfully implemented in 
our prior clinical studies of CBT for dPD and are intended to address the psychiatric complexity and 
executive dysfunction that characterize these patients, as well as to effectively mobilize the patients’ 
social supports, in order to optimize treatment response. For example, the inclusion of family members 
in psychosocial interventions for chronic medical conditions has been linked with improved patient 
outcomes across a range of physical illnesses versus standard care18. Estimates also suggest that 
informal Care-partners assist people with PD an average of 11 times per day in early PD and up to 30 
times per day in later stage disease.19 The beneficial impact of Care-partner involvement on mental and 
physical health in PD has been well demonstrated. 20 Moreover, as described above, dPD is 
characterized by high rates of executive dysfunction and psychiatric comorbidity, factors which have 
been negatively associated with depression treatment response in older adults 21 and in the few 
pharmacologic studies that have examined these relationships in PD. 22 Thus, more intensive behavioral 
strategies which target these clinical correlates of dPD are warranted.  
 
Intervention details. Behavioral strategies for increasing meaningful, pleasurable, and social activities 
will be addressed early in therapy in order to help Veterans maintain and/or increase a sense of purpose 
and fulfillment in their lives, despite the limitations of their medical condition. Collaborative goal-setting 
to safely increase physical activity (i.e., exercise) will be emphasized. Problem-solving regarding physical 
limitations (i.e., ordering food that does not need to be cut in a restaurant, walking for 10 minutes three 
times a day, instead of 30 minutes at one time), as well as strategies for pacing daily activities, and 
setting realistic daily goals, will be conducted to help facilitate these healthy behavioral changes. 
Throughout the course of treatment, Veterans will also be asked to monitor the thoughts (i.e., My life is 

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meaningless) and feelings (i.e., depressed) that they have in response to stressful situations. The 
Veterans’ negative thoughts will be evaluated via the use of a variety of cognitive restructuring 
techniques and replaced with more accurate alternatives as appropriate (“I will still be able to have a 
meaningful life despite the limitations associated with my medical condition”). A major focus will be on 
the modification of thoughts leading to excessive disability, helplessness, loss of control, and 
dependency.  
 
The Veterans’ individual treatment will also incorporate relaxation techniques, such as diaphragmatic 
breathing, progressive muscle relaxation, and guided visualization, in order to address the high 
prevalence of anxiety and somatic complaints found in the PD population.  All 3 techniques will be 
sequentially introduced and emphasis will be dictated by Veteran preference. Separate recordings of 
each relaxation exercise will be made to facilitate both practice and mastery. In order to best manage 
the physical symptoms of anxiety, Veterans will be encouraged to regularly incorporate these relaxation 
strategies into their daily routines and to apply them when confronting stress. Behavioral worry control 
techniques, such as thought stopping, scheduling and postponing worry, and the use of positive 
affirmations, will also be implemented as needed. For Veterans with sleep difficulties, sleep hygiene 
techniques, such as avoiding daytime naps, and establishing bedtime-wakeup routines, will be 
introduced. 
 
Care-partner Sessions: During initial sessions, Care-partners are provided with information regarding the 
psychiatric complications in PD and the CBT model of depression. In later sessions, Care-partners are 
trained to recognize the Veterans’ negative thoughts such as “I am rapidly deteriorating” and to help the 
Veteran replace their negative thoughts with more balanced alternatives (i.e., “I am not rapidly 
deteriorating. My neurologist said I am the same as I was six months ago and did not change my 
medication.”). Techniques for supporting the Veterans in the application of their newly acquired self-
management skills (e.g., daily walks, calling a friend weekly, going to Physical Therapy) are addressed, as 
well as strategies for minimizing the Veterans’ sense of helplessness (e.g., not offering assistance when 
it is not needed). Ways to decrease negative social exchanges (e.g. risk factors for depression like 
criticism) between the Veteran and Care-partner are also targeted. 
 
4.1.1 Drug or Device Interventions 
None 
 
4.2 Dependent Variables or Outcome Measures 
 
The table below illustrates how the study measures will be administered across the study protocol. 
Further description of each measure appears further below.  
 
Table 1: Summary of Measures 
  
  
  
  
 
Domain 
Measure 
Week 0 
(Baseline) 
Week 5 
(Mid-
Treatment) 
Week 10 
(Post-
Treatment) 
1 Month 
f/u 
6 
Month 
f/u 
Aim 1 - Veteran Outcomes 
 
Psychiatric Diagnosis 
SCID 
V 
 
Depression 
HAM-D; BDI-II 
V 
V 
V 
V 
V 
Anxiety  
HAM-A 
V 
V 
V 
V 
V 
Quality of Life 
SF-36 
V 
V 
V 
V 
V 

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Cognitive 
Functioning 
MoCA 
V 
 
 
 
 
Aim 2 -- Care-partner Outcomes 
 
Care-partner Burden 
CDS 
C 
 
C 
C 
C 
Empowerment 
FES 
C 
 
C 
C 
C 
Criticism 
PCS 
V:C 
V 
V:C 
V:C 
V:C 
Aim 3 - Mixed-Methods Veteran and Care-partner Perspective 
 
Telehealth 
Satisfaction 
Satisfaction 
Questions 
V:C 
 
Therapeutic Alliance 
Working Alliance 
Inventory 
V 
V 
 
Semi-structured 
Interview 
V:C 
 
Note: TH-CBT will occur between Weeks 0 and 10. V=measure will be given to Veteran. C=measure will 
be given to Care-partner. Aim 3 measure will only be given to participants in the TH-CBT condition.  
 
 
Screening Assessments:  
 
Structured Clinical Interview for DSM-IV (SCID-IV).23 The SCID is a semi-structured interview for assessing 
the DSM Axis I psychiatric diagnoses and the depression inclusion criterion . As many symptoms of 
depression (i.e., fatigue, psychomotor retardation) overlap with physical aspects of PD, an NIH working 
group has recommended taking an inclusive approach when making a psychiatric diagnosis in PD.90 
Thus, all mood symptoms are counted towards the depressive disorder diagnosis, despite the potential 
overlap of mood symptoms with core PD symptoms as long as one of the two key features of a DSM 
depressive disturbance (i.e., sad mood, loss of interest/enjoyment) are present.  
 
Montreal Cognitive Assessment Scale (MoCA).24 The MoCA is a brief cognitive screening tool that is 
sensitive to the effects of cognitive decline in PD. A score of 21 has been identified as an optimal cut-off 
for possible dementia in PD (sensitivity 81%, specificity 95%).88 This cut-off score will allow us to 
exclude patients with more serious cognitive limitations who may not be appropriate for this type of 
treatment,2 while still allowing patients with a broad range of cognitive abilities to participate. As a 
result of this exclusion, we will not be enrolling participants with impaired capacity to consent.  
 
Outcome Assessments:  
The following outcomes measures will be administered to the Veteran. The primary outcome will be 
change in clinician-rated depression, as measured by the Hamilton Depression Rating Scale (HAM-D), 
which is a well-established clinician-rated instrument for depression.25 Secondary clinical outcomes 
include responder status 15 (defined a priori as depression very much improved (1) or much improved (2) 
on the CGI-Improvement Scale; CGI-I:, depression severity (as assessed by the Beck Depression 
Inventory-II, which is a well-established self-report measure of depression), 26 clinician-rated anxiety ( 
Hamilton Anxiety Rating Scale (HAMA),27 quality of life (Medical Outcome Study Short Form [SF-36]),28  
 
The Veteran will also complete a measure of Perceived Criticism.29 The scale consists of ratings of 
perceived criticism and reactivity to criticism. The respondent completes the following two items: 1) 
How critical do you think you are of your family member?; 2) How critical do you think your family 
member is of you? For reactivity to criticism, Veterans completed the following two items: 1) When your 

Protocol 6/18/15  
              
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family member criticizes you, how upset do you get?; 2) When you criticize your family member, how 
upset does he/she get? For perceived criticism and reactivity to criticism, items are rated 1-10 and were 
summed to generate a score ranging from 1-20 with higher scores indicating greater perceived 
problems. 
 
Finally, Veterans will also complete treatment Satisfaction measures, 30,31, as well as the Working 
Alliance Inventory-Short Form. 32 The qualitative data will be assessed with a semi-structured interview 
that will elicit a narrative on their experience with the treatment (see Measures). The qualitative 
interview will only be give to a subsample and will take place at endpoint (see Research Design and 
Methods, 3rd paragraph).  
 
The following outcome measures will be administered to the Care-partner. Family Empowerment will be 
assessed with the 12-item family subscale from the Family Empowerment Scale.33 Each item is rated 
from 1 (not at all) to 5 (very true), resulting in a sum score of 12 - 60. This measure captures the degree 
to which Care-partners feeling they understand and respond to their Veterans’ illness. Care-partners will 
also complete a measure of Caregiver Distress 34 and Perceived Criticism (same measure as Veteran).29 
 
Qualitative Data: The qualitative interviews (see attached) will be theme-driven, with participants being 
prompted to discuss their perceptions of TH-CBT. The analysis section below describes the qualitative 
analytic process.  
 
4.3 Risk of Harm and Protections Against Risk 
 
The proposed study involves non-invasive interview assessment measures and a psychosocial 
intervention, both of which are associated with minimal risk. The risk associated with each component 
of the research is outlined below, followed by the steps we will take to minimize these risks.    
 
Structured Interviews, Rating Scales, Questionnaires, and Electronic Medical Record Review:  
These types of assessment procedures are commonly used in psychiatric research and are generally 
associated with minimal risk.  Problems that might arise during research assessments or therapy 
sessions would be related to emotional distress. To address this risk, all assessors and therapists will 
receive training and supervision pertaining to depression in Parkinson’s disease from Co-Investigator Dr. 
Roseanne Dobkin, and on assessing and responding to suicide risk, from the PI, Dr. Alejandro Interian. 
Thus, staff will be trained and closely supervised to directly intervene with any emergent emotional 
distress in a manner consistent with standard clinical practice. Study clinicians, Kurt Bopp and Rachael 
Miller, are both licensed clinical social workers.  At the same time, Dr. Interian will be accessible to 
intervene with any psychiatric emergent events and will do so in a manner consistent with standard 
clinical practice, including the full range of clinical options (i.e., crisis assessment, crisis counseling, and 
intervention, providing safety planning, contacting family for support, linkage to indicated treatment, 
use of emergency services).  In addition, the research team members are experienced in working with 
veterans on the facility high-risk list, have had training in VA crisis and suicide prevention protocols, and 
work closely with the VA Suicide Prevention Team.  
In addition, Dr. Margery Mark (Co-Investigator) is our study’s movement disorder specialist who will 
provide consultation for the team, to allow for identification of need to coordinate with the participant’s 
usual care neurologist/physician with emergent issues pertaining to PD. She will not interact with 
patients or access PHI.  
 

Protocol 6/18/15  
              
13 
 
The other primary foreseeable risk is associated with breaches of confidentiality of study data or 
personal information.   
 
In order to protect the privacy of participants, we will closely adhere to VA regulations.  The recruitment 
process will entail the use of a contact spreadsheet that contains protected health information (minimal 
PHI needed to consider basic eligibility and contact information for recruitment).  This administrative 
spreadsheet will be stored separately from the study’s research data.  No protected or personal health 
information will ever be recorded or stored in a permanent research database.  The contact spreadsheet 
will be placed on a secure VA server.  The spreadsheet will not be downloaded to a personal computer 
and will only be used by authorized members of the research team.  The database containing 
demographic information and interview responses will be saved separately.  This process ensures that 
protected health identifiers  are never recorded in the research database.  The data will be destroyed 
following the release of VA regulations on retention of research records and will follow the VA’s policy 
for destruction of study records.   
 
With respect to other data, all paper-based information containing personal identifiers (such as consent 
forms) collected in this study will be kept in locked filing cabinets accessible only to the research staff of 
the VA NJ Health Care System.  All assessment data will be collected in a private VA office and directly 
entered into a computer database, and stored in password-protected VA files on the secure VA server. 
This will include the study teams secure network folder as well as VINCI. VINCI is the VA’s secure VPN 
portal for research data and can be used to allow approved VA collaborators to access data, without the 
data leaving the secure VA computing environment. We will use VINCI to share de-identified interview 
transcripts with Dr. Mavandadi. Assessment data will be identified by ID number only and will not be 
associated with any personal identifying information.   The database that contains the link between the 
subjects’ names and their ID numbers will be maintained on a separate password-protected spreadsheet 
on the secure VA network. The final research database will not contain any PHI. No personal identifying 
information will be included in published findings from the study or in reports to the funding agency. 
The specific time frame for destruction of identifiers will be determined following the release of VA 
regulations on retention of research records and will follow the VA’s policy for destruction of study 
records.   
 
In addition to the above data, we will also be audio-recording TH-CBT sessions and semi-structured 
interviews for the purpose of conducting fidelity reviews to ensure clinicians are following the protocol 
in delivering the treatment and for qualitative analysis.  All assessment interviews will also be 
audiorecorded to allow for quality control. In addition, this will allow a second rating by a blind rater, in 
instances where the experimental blind is broken.  
 
Individuals will not be identified by name during assessment interviews.  Participants will be aware that 
some sessions will be recorded and will be requested to provide signed consent when consenting to 
participate in the research study  and verbal assent prior to initiating each recording.  Following each 
recording, we will immediately transfer the recordings from the digital recorder to the VA secure server 
and the audio file will be assigned a code name.  The recording will be deleted from the original device 
according to VA protocol.  The digital recorder will be kept in a locked cabinet in the VA office of the 
interviewer. The file name for each recording will not contain PHI and will coded by research ID.  
 
Review of deidentified audiorecordings will be conducted by our Co-Investigator, Dr. Roseanne Dobkin, 
Rutgers-Robert Wood Johnson Medical School. Dr. Dobkin will be credentialed at VANJHCS (i.e., WOC) 

Protocol 6/18/15  
              
14 
 
and will be able to access the team’s files and folder on the secured server.  Audiorecordings will not be 
sent outside of VA New Jersey.  
 
4.4 Potential for Benefit 
 
Study Veterans and non-participating depressed PD Veterans and their Care-partners may benefit from 
the proposed project. Prior research with the study intervention indicates that at least some benefit is 
likely. Specifically, the proposed telehealth CBT treatment package has the potential to enhance 
emotional and physical health for Veterans with PD through the alleviation of depression and its 
associated psychiatric and functional correlates, as well as to improve access to evidence-based mental 
health care in PD. There is also the potential for benefit to Care-partners, in terms of empowerment, 
reduced burden, and improved communication patterns with their Veteran with dPD. Finally, 
participants in both study conditions will be receiving greater clinical monitoring of depressive 
symptoms, relative to standard care, via the study assessment. Greater monitoring will help detect 
clinical worsening and mental health crisis, allowing for appropriate care to be provided and 
coordinated, thereby providing additional benefit. 
 
If the treatment coincides with clinically significant improvements, the results will be published so that 
other mental health professionals can more successfully treat dPD and other complex medical and 
geriatric conditions.  The improved functioning of PD patients will also benefit society, larger family 
units, and the healthcare system.  Neurologists, psychiatrists, psychologists, and primary care physicians 
will also benefit in that they will ultimately have additional empirically validated treatment options from 
which to choose when working with depressed PD patients and Care-partners, as well as research 
support for alternative methods of treatment delivery that have the potential to reduce access barriers 
to mental health treatment in this and other geriatric and medically complex populations. 
 
 
5. Data Handling and Statistical Analysis 
 
Unless otherwise indicated, all of the analyses below will use mixed models analysis to examine 
treatment effects on the specified dependent variable. There will be one between-group variable (TH-
CBT versus control), one repeated measure variable (time), and group-by-time interactions (effect of 
interest). We will consider several correlational structures between repeated measures (e.g., compound 
symmetry) and determine the best structure using the Akaike’s Information Criterion (AIC). Random 
effects will be specified for each subject. For each dependent variable, we will analyze the effect of 
interest (i.e., group X time) separately at each post-randomization assessment point. The models will 
include demographic covariates (age, sex) as indicated. Standard residual diagnostics will be applied. In 
the event of unaccounted-for outliers, analyses will be run with and without the outliers. Should the 
residuals deviate unacceptably from normality assumptions, we will use robust estimation as described 
and catalogued by Wilcox.35 
 
AIM 1: To evaluate the effectiveness of TH-CBT for improving Veteran outcomes in dPD. Primary 
Hypothesis: Depressive symptoms will decrease more for Veterans receiving TH-CBT, than for Veterans 
in the control group. The HAM-D is the primary depression outcome measure. Secondary Hypotheses. 
There will be more treatment responders in the TH-CBT group. Analyses examining depression 
treatment response will utilize the CGI-I (response equals CGI-I score of 1- 2). 36 Fisher’s exact test will be 
used to test the hypothesis related to treatment response. A sensitivity analysis will be performed using 
logistic regression to examine the possible importance of covariates. Secondary Hypotheses: Secondary 

Protocol 6/18/15  
              
15 
 
outcome measures for Veterans receiving TH-CBT will show greater improvement (BDI, HAM-A, SF-36) 
over time than for those of Veterans in the control group. As these measures can be expected to be 
correlated, the significance threshold adjusting for multiple-testing will be determined by permutation-
based analysis. 
 
AIM 2: To examine the impact of TH-CBT for dPD on a variety of Care-partner outcomes. Hypotheses: 
TH-CBT Care-partners will feel more empowered (FES), report less distress (CDS) and be less critical (to 
the Veteran; PCS) relative to controls. The analysis approach will be the same as in Specific Aim 1 
 
AIM 3: The following analytic process will be used to qualitatively analyze data collected from semi-
structured interviews. Interviews will be audiorecorded, transcribed, and imported into a qualitative 
analysis software program (i.e., Atlast.ti). Analytic methods will be guided by grounded theory,37 using 
an open, inductive coding approach. Coding will be iterative, will rely on the constant comparison 
method, and will utilize multiple raters. Regular meetings will be utilized to build the coding framework 
and achieve consensus between raters when coding disagreements occur. Once the qualitative data 
have been coded, indices (e.g., number and % of statements within each narrative) will capture the 
extent to which each participants’ narrative responses fall into each thematic category. This will allow 
for comparisons to be made between groups established by the quantitative data (e.g., themes 
according to responder versus nonresponder) and analysis of associations among quantitative variables 
(e.g., Care-partner burden, client satisfaction) and qualitative themes. The aim of this integration will be 
for the qualitative data to generate a contextualized understanding, based on participants’ perspectives, 
on the themes associated with the objectively measured (i.e., CGI response) success of the treatment. 
 
6. Data and Safety Monitoring 
 
In addition to the detailed measures described above to maintain the safety of research participants and 
their data, this study will have a Data and Safety Monitoring Board (DSMB), which will serve as an 
oversight committee, reviewing any major modifications to the research design and conduct of the 
study and making recommendations according to the NIH Policies for data and safety monitoring as 
described below. Definition of Adverse Events and Serious Adverse Events will be determined in 
accordance with the DSMB and the IRB. Reports of adverse events will be made to the IRB according to 
the standards for expedited reporting. 
The individuals who will serve on the DSMB are: 
Matthew Menza, M.D., Chairman of the Department of Psychiatry and Professor of Psychiatry and 
Neurology at Robert Wood Johnson Medical School (RWJMS), with 20 years of clinical and research 
experience in the psychiatric complications of PD.  
 
Jayne Wilkinson, M.D. Associate Clinical Director, Parkinson's Disease Research, Education and Clinical 
Center (PADRECC), Philadelphia Veterans Affairs Medical Center, with notable expertise in the provision 
of remote neurological care in PD.  
 
Daniel Schneider, M.D., a Movement Disorders Specialist at Rutgers-RWJMS and the medical director of 
the Rutgers-RWJMS Deep Brain Stimulation Clinic, who is dually- boarded in both Neurology and 
Psychiatry. 
 
The specific goals of this joint DSMB are: 

Protocol 6/18/15  
              
16 
 
1. To review new or modifications to existing risk management protocols. 
2. To review procedures and decisions regarding the adequate protection of specific patients when 
investigators move into risk management protocols because of adverse events or clinical 
deterioration. 
3. To review progress toward meeting enrollment goals. 
4. To review procedures for maintaining the confidentiality of data, and quality of data collection, 
management, and analyses. 
5. When appropriate, serve as final arbiters of whether individual patients should be removed from a 
protocol. 
6. To recommend continuation, discontinuation, modification, or termination of a study based on 
emerging data (in the study and literature) and evaluation of risk/benefit ratio. 
7. To conduct annual reviews to determine whether patient safety has been adequately safeguarded. 
8. To meet at least once yearly with the principal investigator to review progress reports. 
 
The PI will forward all DSMB reports to the IRB for review.  
The general purpose of the data monitoring plan will be to maximize the safety and privacy of all study 
participants, and ensure the integrity, validity, and confidentiality of the data collection and analysis 
procedures. These objectives will be accomplished through regular monitoring and oversight by the 
Principal Investigator. The Principal Investigator will report any serious and unexpected adverse events 
and unexpected problems that involve risk to the participants or others, or any breaches in 
confidentiality to the Institutional Review Board (IRB).  
 
Each year, the PI will include a summary of data safety monitoring activities in the annual progress 
reports to the IRB. These reports will include: (1) whether participants’ safety, privacy and 
confidentiality has been consistently assured by the investigators; (2) review of interim data analyses 
that bear on outcomes of the study and risk/benefit ratios to participants, including recommendations 
for new statistical analyses; (3) judgment as to whether research instruments have been administered in 
a uniform manner and in a way that maintains the participants’ privacy; (4) a review of the study’s 
progress toward recruitment goals, quality of data (e.g., appropriate completion of forms), and 
participant retention/attrition rates; and, (5) a review of new scientific literature pertinent to the safety 
of participants or ethics of research participation.  
 
There will be regular, ongoing communication between the PI and the local IRB. While no serious and 
unexpected adverse events are expected as a result of participation in the research study, any 
unanticipated study problems will be reported to the local IRB. As noted above, the study clinicians will 
take all clinically appropriate actions to prevent and treat psychiatric emergencies in participants. 
 
7. Reporting Results 
 
We will not be conducting medical tests or collecting any other measures that would require patient 
notification. In terms of professional reporting, aggregate results will be reported in a final report to the 
funding agency as well as in presentations at professional meetings and in peer-reviewed journals. 
 
 
 

Protocol 6/18/15  
              
17 
 
8. Bibliography 
 
 
 
1. 
Cummings JL. Depression and Parkinson's disease: a review. Am J Psychiatry. 1992;149(4):443-
454. 
2. 
Starkstein SE, Mayberg HS, Leiguarda R, Preziosi TJ, Robinson RG. A prospective longitudinal 
study of depression, cognitive decline, and physical impairments in patients with Parkinson's 
disease. Journal of Neurology, Neurosurgery & Psychiatry. May 1, 1992 1992;55(5):377-382. 
3. 
Carter JH, Stewart BJ, Lyons KS, Archbold PG. Do motor and nonmotor symptoms in PD patients 
predict caregiver strain and depression? Movement Dis. 2008;23(9):1211-1216. 
4. 
Weintraub D, Burn DJ. Parkinson's disease: The quintessential neuropsychiatric disorder. 
Movement Dis. 2011;26(6):1022-1031. 
5. 
Dobkin RD, Rubino JT, Friedman J, Allen LA, Gara MA, Menza M. Barriers to Mental Health Care 
Utilization in Parkinson’s Disease. J Geriatr Psych Neur. June 1, 2013 2013;26(2):105-116. 
6. 
Reijnders JSAM, Ehrt U, Weber WEJ, Aarsland D, Leentjens AFG. A systematic review of 
prevalence studies of depression in Parkinson's disease. Movement Dis. 2008;23(2):183-189. 
7. 
Forsaa EB, Larsen JP, Wentzel-Larsen T, Herlofson K, Alves G. Predictors and course of health-
related quality of life in Parkinson's disease. Movement Dis. 2008;23(10):1420-1427. 
8. 
McCrone P, Allcock LM, Burn DJ. Predicting the cost of Parkinson's disease. Movement Dis. 
2007;22(6):804-812. 
9. 
Ravina B, Camicioli R, Como PG, et al. The impact of depressive symptoms in early Parkinson 
disease. Neurology. July 24, 2007 2007;69(4):342-347. 
10. 
Swartrauber K, Graf E, Chen E. The quality of care delivered to Parkinson's disease patients in 
the U.S. Pacific Northwest Veterans Health System. BMC Neurology. 2006;28(6):26. 
11. 
Chen P, Kales HC, Weintraub D, et al. Depression in veterans with Parkinson's disease: 
frequency, co-morbidity, and healthcare utilization. Int J Geriatr Psychiatry. 2007;22(6):543-548. 
12. 
Qureshi SU, Amspoker AB, Calleo JS, Kunik ME, Marsh L. Anxiety disorders, physical illnesses, 
and health care utilization in older male veterans with Parkinson disease and comorbid 
depression. J Geriatr Psych Neur. 2012;25(4):233-239. 
13. 
Veterans Health Administration Service Support Center. VHA Diagnosis Cube accessed via 
intranet on  6/3/142014. 
14. 
Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56. 
15. 
Guy W. ECDEU Assessment Manual for Psychopharmacology. Washington, D.C: US; 1976. 
16. 
Dobkin RD, Menza M, Allen LA, et al. Cognitive-behavioral therapy for depression in Parkinson's 
disease: a randomized, controlled trial. Am J Psychiatry. 2011;168(10):1066-1074. 
17. 
Dalrymple-Alford J, MacAskill M, Nakas C, et al. The MoCA Well-suited screen for cognitive 
impairment in Parkinson disease. Neurology. 2010;75(19):1717-1725. 
18. 
Martire LM LA, Schulz R, Miller GE, Helgeson VS. Is it beneficial to involve a family member? A 
meta-analysis of psychosocial interventions for chronic illness. . Health Psychology. 2004;23:599-
611. 
19. 
Carter JH, Stewart BJ, Archbold PG, et al. Living with a person who has Parkinson's disease: the 
spouse's perspective by stage of disease. Movement Dis. 1998;13(1):20-28. 
20. 
Ravenek M, Schneider M. Social support for physical activity and perceptions of control in early 
Parkinson's disease. Disability Rehabilitation. 2009;31:1925-1936. 
21. 
Andreescu C, Lenze EJ, Mulsant BH, et al. High worry severity is associated with poorer acute 
and maintenance efficacy of antidepressants in late‐life depression. Depression and Anxiety. 
2009;26(3):266-272. 

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22. 
Dobkin RD, Menza M, Bienfait KL, et al. The impact of antidepressant treatment on cognitive 
functioning in depressed patients with Parkinson’s disease. The Journal of neuropsychiatry and 
clinical neurosciences. 2010;22(2):188. 
23. 
First MB, Spitzer RL, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV Axis I 
Disorders. New York: Biometric Research Department, New York State Psychiatric Institute; 
1998. 
24. 
Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief 
screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695-699. 
25. 
Hamilton M. Hamilton Depression Scale. In: Guy W, ed. ECDEU Assessment Manual For 
Psychopharmacology, Revised Edition. Rockville, MD: National Institute of Mental Health; 
1976:179-192. 
26. 
Beck AT, Steer RA, Brown GK. Manual for Beck Depression Inventory-II. San Antonio: 
Psychological Corporation; 1996. 
27. 
Hamilton M. The assessment of anxiety status by rating. British Journal of Medicine and 
Psychology. 1959;32:50-55. 
28. 
Ware JE, Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual 
framework and item selection. Medical Care. Jun 1992;30(6):473-483. 
29. 
Hooley JM, Teasdale JD. Predictors of relapse in unipolar depressives: expressed emotion, 
marital distress, and perceived criticism. Journal of Abnormal Psychology. 1989;98(3):229-235. 
30. 
Dobscha SK, Corson K, Solodky J, Gerrity MS. Use of videoconferencing for depression research: 
enrollment, retention, and patient satisfaction. Telemedicine Journal & e-Health. 2005;11(1):84-
89. 
31. 
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: 
development of a general scale. Evaluation and Program Planning. 1979;2(3):197-207. 
32. 
Hatcher RL, Gillaspy J. Development and validation of a revised short version of the Working 
Alliance Inventory. Psychother Res. 2006;16(1):12-25. 
33. 
Koren PE, DeChillo N, Friesen BJ. Measuring empowerment in families whose children have 
emotional disabilities: A brief questionnaire. Rehabilitation Psychology. Win 1992;37(4):305-321. 
34. 
Cousins R, Davies AD, Turnbull CJ, Playfer JR. Assessing caregiving distress: A conceptual analysis 
and a brief scale. Br J Clin Psychol. 2002;41(4):387-403. 
35. 
Wilcox RR. Introduction to robust estimation and hypothesis testing: Academic Press; 2012. 
36. 
Frank E, Prien RF, Jarrett RB, et al. Conceptualization and rationale for consensus definitions of 
terms in major depressive disorder: Remission, recovery, relapse, and recurrence. Arch Gen 
Psychiatry. 1991;48(9):851-855. 
37. 
Corbin JM, Strauss AL. Basics of qualitative research: Techniques and procedures for developing 
grounded theory: Sage Publications, Inc; 2008. 
 
 
 
 
 
 
 
 
 
 
 

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Protocol Amendments 
1. 8/11/16: 
We requested a full waiver of HIPAA authorization for caregiver research subjects only as we are not 
collecting any private health information from caregiver participants.  This includes an exemption of 
medical record notes in the medical chart for caregiver research subjects only.  We will still obtain 
written, informed consent from caregivers to participate in the study. 
 
2. 10/19/16: 
First, we requested a waiver of the requirement to obtain written informed consent from both 
Veterans and their Care Partners, as mailing and requiring the return of signed consent forms prior 
to participation for this minimal risk study creates an undue burden for potential participants and a 
significant time lag.  Second, we modified the inclusion criteria requiring a care-partner, amending 
the criterion to include a willingness to find a caregiver to participate in the study.  Third, we 
removed the requirement that subjects be recruited from VA New Jersey only and expanded 
recruitment of subjects to Veterans enrolled in VHA, including those from other facilities.  Fourth, 
we added language to the protocol for clarification that does not constitute a change to the content 
of the study protocol. 
 
3. 1/6/16: 
First, we updated the diagnostic interview from the SCID-IV to the SCID-5 to ensure that diagnoses 
of subjects are up to date with current accepted standards.  Second, we requested approval of 
additional advertising materials from the research to be used at other VA facilities.  Third, we added 
two additional questions to the follow-up assessments about medical issues encountered and 
psychotropic medication changes since the last assessment.  Fourth, we adapted the home 
telehealth survey questionnaire for both Veteran and Care Partner participants to increase the 
relevance to study intervention. 
 
4. 4/6/17: 
First, we requested to add an additional recruitment procedure through Michael J. Fox Clinicial Trial 
finder to improve our ability to reach our recruitment target.  Second, we added language to all 
regulatory documents and advertisements consistent with our approved previous amendment to 
recruit from VA facilities other than VANJ.  
 
5. 4/21/17: 
First, we requested to add additional information in our intake assessment to assist an independent 
expert to confirm diagnoses of Parkinson’s Disease..  Second, we specified the process by which we 
will have interviews transcribed by VA HSR&D transcription services. 
 
6. 6/9/17: 

Protocol 6/18/15 
20 
We requested to modify the wording of the informed consent document to clarify the payment 
schedule for participant incentives and to clarify that incentives are for study assessments only and 
not the study treatment. 
7.
9/22/17:
We updated a previous amendment to specify that our team will utilize VA Sharepoint, a secure, VA
firewall-protected link, to transfer files to HSR&D’s transciption service.
8.
7/25/18:
We added the Parkinson’s Disease-Specific Anxiety Inventory (PDSAI) to the set of self-report
measures completed by participants at each of three time points: at baseline (week 0), treatment
endpoint (week 10) and final (six-month) follow-up.