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VA Palo Alto Health Care System Research Studies

    
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A Double-Blind, Randomized, Placebo-Controlled Trial of Adjunctive Suvorexant for Treatment-

People with bipolar disorder (manic depression) often have trouble sleeping. This can lead to worsening problems with mood and functioning. • Participants will have an initial psychiatric exam and will be monitored during the 14-week study by a psychiatrist who specializes in bipolar disorder. • For one week, participants will add suvorexant or a placebo to their current medication treatment. • The following week, and for the next 3 months, all participants will receive suvorexant. • There is no cost to participants and participants will receive some compensation for time and travel.

Alcohol and Liver Disease Research Study

This project studies the effectiveness of whether a new computer program that provides education to Veterans about the potential health effects of alcohol is useful to Veterans with liver disease. Participating in this study entails three interviews over the course of six months: one in-person interview and two phone interviews. Compensation includes: $50 for in-person interview and $25 each for two phone interviews, for a possible total of $100.

Anxiety Treatment Study in Veterans aged 60+

Anxiety Treatment Study in Veterans aged 60+


Would you like to learn ways to manage your anxiety and stress? You may be eligible to participate if you:

  • Are a Veteran aged 60 years or older, 
  • Have anxiety or worries that are bothersome or distressing 
  • Are not receiving regular weekly psychotherapy
  • Do not have a psychotic disorder or dementia


Our program includes:

  • A 12-week study 
  • Random assignment into one of two treatments
  • Both treatments can be watched at home via DVD or on our website.
  • Up to $140 compensation


Participation includes:

  • Attending a 3-hour assessment before and after 12 weeks


If needed, portable DVD players are available for Veterans to take home and use during the duration of the study- you do not have to be technically savvy to be included in the study or have internet in your home.


Compensation: Up to $140 for the study – ($60 for in-person assessments and travel and $10 for monthly phone calls) 

Apnea and PTSD Study to Increase CPAP Adherence

The purpose of this research program is to study which of two treatments, Cognitive-Behavioral Therapy, one of several behavioral treatments, or Education-Based Treatment, works best for adults with Obstructive Sleep Apnea (OSA) and Post-Traumatic Stress Disorder (PTSD) to increase the regular use of a CPAP machine.

You will be compensated up to $340 for completing all sessions.

Balance Study

We are seeking participants, ages 55-85, with balance problems to investigate the use of special lights to improve morning balance. Two separate overnight stays at the VA Palo Alto Sleep Lab are required. Participants must be healthy, non-smokers, ages 55-85, with a history of falls or dizziness in the past year and without sleep problems. Compensation up to $200.

Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI Trial)

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options. Patients will receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment, and their outcomes will be compared.

Bone Health after SCI: Comparing Forces during FES-Assisted Exercises

This project will look at forces generated in the legs of individuals with spinal cord injury (SCI) while they perform several activities with functional electrical stimulation (FES) of muscles in their legs. The results of this study will help researchers and clinicians determine whether certain FES-assisted exercises may have potential to prevent or reverse bone loss in the legs after SCI.

Brain Training Study

The Menlo Park VA is currently looking for Veterans who struggle with alcohol use and post-traumatic stress symptoms to participate in a research study that seeks to examine the impact of computerized brain training games on recovery outcomes. The study requires ten visits to our lab over the course of about six months. Eligible Veterans who participate will receive up to $390 for completing all portions of the study.

Breathing Meditation for Post-Traumatic Stress Disorder (PTSD)

The purpose of this study is to determine whether a breathing meditation technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as the standard psychotherapy (Cognitive Processing Therapy – CPT-C). Participants' PTSD symptoms will be assessed before treatment, at the end of treatment, one month after treatment, and 12 months after treatment. Compensation: $400

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

This study is comparing intensive medical management with interventions treated asymptomatic carotid stenosis. Patients either undergo a procedure, or are followed closely. Patients included in the study benefit from Intervent - a lifestyle coaching program that provides nutrition advice, weight loss coaching, and medical management.

Connecting Women to Care: Home-Based Therapy for Women Veterans

Have you experienced military sexual trauma? Are you interested in receiving psychotherapy from the comfort of your home?

The CWC study is evaluating in-home delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) and Present Centered Therapy (PCT), for women Veterans with history of MST who are currently experiencing difficulty with mood and relationships.


STAIR and PCT both focus on improving overall mood and functioning, and do not require discussion of traumatic memories. Veterans will complete 12 sessions of weekly psychotherapy with a trained therapist, and be assessed before treatment, 6 weeks into study, 12 weeks into study, and 2 and 4 months after enrollment.

Overall participation in the study is approximately 7 months. Compensation is up to $160 for completion of all assessments.

Development of a Brief Measurement of Patient Activation for Veterans (PAVE) Study- Online Survey

Are you being treated for a chronic physical or mental health condition? If so, we want to hear what you think about your health and healthcare experiences! The survey takes about 15-20 minutes and participants will be sent a $20 target gift card in the mail to compensate them for their time. Participants who have completed a PAVE in person or phone interview are not eligible to participate. To take the survey please type this in your internet browser:   tiny.cc/PAVEsurvey   (Note:  you don't need to type ".com" after this or anything else)

Evaluation of the 4th Generation QuantiFERON–TB test (QFT-Plus) for the detection of tuberculosis infection

QuantiFERON® (QFN) technology provides a simple and sensitive method for measuring cell mediated immune responses (CMI) using whole blood, without the need for lymphocyte purification. This involves the stimulation of whole blood directly in blood collection tubes that contain antigen/stimulants. The tubes are simply mixed and then placed in an incubator. If T lymphocytes are present in the blood sample that are specific for the antigens/stimulants (i.e., if the individual has been infected or exposed to the agent being tested for) they will respond in a number of ways, one of them being the release of IFN-? into the plasma. The next day, plasma is harvested and assayed for the presence of IFN-? using a sensitive, one-step ELISA.

In 2001 the tuberculosis diagnostic test QuantiFERON®-TB (QFT®), developed by QIAGEN (now QIAGEN, a QIAGEN company), was approved by the Food and Drug Administration (FDA). Since then, QIAGEN have developed two more generations of the test, QuantiFERON®-TB Gold and QuantiFERON®-TB Gold In-Tube (QFT-3G), approved by the FDA in 2004 and 2007 respectively.

QFT-3G measures responses to the Mycobacterium tuberculosis (Mtb) antigens ESAT–6, CFP–10 and TB7.7 and these antigens are not produced by any strains of the BCG vaccine. The tuberculin skin test (TST) is frequently falsely-positive in BCG vaccinated people, resulting in the TST having poor specificity. A principle benefit of QFT-3G is that it is unaffected by BCG vaccination and the test has a demonstrated specificity of > 99%, along with a sensitivity of 88.7% in untreated TB patients (QFT Package insert 1).

The 4th generation QuantiFERON TB test (QFT-Plus) aims to further increase the sensitivity of the assay and in particular to increase the utility of the test in populations of patients co-infected with HIV. The design of the QFT-Plus test includes a set of peptide antigens designed specifically to stimulate Mtb-specific CD8+ T lymphocytes, which may be of importance for the functionality of the assay in patients with low CD4+ T cell counts2-3.

STUDY OBJECTIVES:

To compare the positivity rate of the QFT-Plus test to the current QFT-3G test in subjects with a mixed risk for M. tuberculosis infection, and to evaluate the rate of test result conversion and reversion upon repeat testing. Based on the results of a risk questionnaire (Appendix 2), subjects will be stratified into a ‘low risk’ or ‘known risk’ group for TB exposure and results re-analyzed to assess the above parameters in relation to TB exposure risk.

Exoskeletal-Assisted Walking in Persons with SCI

Purpose: To determine the effects of exoskeletal-assisted walking in the home/community on the quality of life of Veterans with SCI. Physical, mental and social well-being changes will be evaluated with total body fat mass determination and quality of life questionnaires.

Participation is open only to Veterans and Active Duty Military Service Members.

Do you…
• have a spinal cord injury at or below C6?
• have a spinal cord injury greater than 6 months?
• have hand grip function?
• use a wheelchair as your primary mode of mobility?

Are you…
• less than 220 pounds?
• at least 21 years of age?

If you said “yes” to all of the questions above, you may qualify for this study.

Additional screening criteria will be evaluated by the study team prior to entry in the study.

Time commitment is approximately 10 months.


Investigation of the Freespira Breathing System in the Treatment of PTSD

After a trauma or life-threatening event, it is common to have reactions such as upsetting memories of the event, increased jumpiness, or trouble sleeping. If these reactions do not go away or if they get worse, you may have Posttraumatic Stress Disorder (PTSD).You are invited to participate in a research study of a noninvasive, respiratory biofeedback device as a potential treatment for PTSD. The Freespira Breathing System (FBS) was cleared by FDA in 2013 and is indicated for the treatment of symptoms associated with Panic Disorder (PD) including panic attacks, but it is not known whether such treatment will provide similar improvements in patients with PTSD. The treatment of PTSD is an area of great unmet need, with medication treatments providing minimal benefit and current psychotherapy treatments burdensome to deliver. We hope to learn, (after the patient-user is trained to control their respiratory rate and end-tidal CO2 levels by guiding the patient-user through a structured series of monitored breathing exercises utilizing real-time values of RR and EtCO2) that use of the device reduces symptoms of panic in patients with PTSD. The primary goal of this study is to determine whether the FBS will produce similar benefit (both in quality and magnitude) in the defined population of patients with PTSD.

Jet Lag Study

This is a research study investigating the use of bright light to improve night time alertness and change the timing of the circadian clock.

• 2-day/night stay at the VA Sleep Lab
• 2-weeks of at-home sleep monitoring

Participants must be healthy, non-smokers, without sleep problems. Volunteers paid up to $300 for successful completion of 2-day/night stay in VA Sleep Lab.


Complete questionnaire before and after light testing.

Light & Mood Study

This is a research study to investigate the use of light to improve sleep, mood, and performance.

Four overnight stays at the VA Sleep Lab.

Four weeks of at-home sleep monitoring.

Participants must be healthy, non-smokers, without sleep problems, between 18-35 years old.

Compensation up to $650.

For more information: Coordinator: yvonne.quevedo@va.gov or call 1-650-849-1971

Long-Term Effectiveness of Walking Training in Patients with Knee Osteoarthritis

This study will investigate novel methods for treating individuals with early to moderate knee osteoarthritis that is isolated to the inside (medial) half of the knee. The methods involve training individuals to maintain a consistent angle that their feet point relative to their direction of walking. We aim to learn if these methods provide a long-term benefit in reducing pain and improving function.

Mobile Tablet Education to Advance Caregiver Health (Mobile TEACHing)

The goal of this project is to assess the potential benefits of dementia education and caregiver skill-building training. It is designed specifically for family members caring for Veterans with dementia of any cause. The intervention is delivered through mobile media devices (i.e., tablets) to family members in their homes.

Online Treatment Study for PTSD

Do you...
• Avoid activities
• Have relationship problems
• Have difficulties sleeping
• Experience flashbacks or nightmares
• Feel jumpy or startle easy
• Feel detached or disinterested

You may be eligible to participate in a research study. The study studies one of the leading PTSD treatments, called Prolonged Exposure, delivered through a therapist-supported Web-based program that can be completed at home.

This is a STRONG STAR study. STRONG STAR is a research consortium funded by the U.S. Department of Defense’s Psychological Health and Traumatic Brain Injury Research Program to develop and evaluate the most effective early interventions possible for the detection, prevention, and treatment of combat-related PTSD in active-duty military personnel and recently discharged Veterans.

STRONG STAR investigators hope to improve countless lives by preventing the onset of chronic PTSD in a new generation of Veterans.

Compensation is $125 for completing all three assessments.


This study requires
• Access to internet
• Desktop or laptop operating Windows 7 or higher/Mac El Capitan or higher

The study involves 10 self-directed sessions (45-60 mins each) and three calls with a therapist.


Who can participate
• OIF/OEF/OND Veterans or active-duty personnel
• Ages 18 to 65
• Currently experiencing symptoms of PTSD

If so, you may be eligible for this study offering treatment at no cost.

Learn more and see if you're eligible for this study here:  studypages.com/ptsd


PAVE Study

Participants are asked to complete an interview in person or over the phone in which they are asked to take a survey and provide they're feedback on the survey questions. Participants only need to complete one interview that will last from 45-60 minutes and are compensated with a $20 target gift card for their time.

PAVE Study- Online Survey

Are you being treated for a chronic physical or mental health condition? If so, we want to hear what you think about your health and healthcare experiences! The survey takes about 15-20 minutes and participants will be sent a $20 target gift card in the mail to compensate them for their time. Participants who have completed a PAVE in person or phone interview are not eligible to participate. 

Personalized gait training with feedback to reduce knee pain from osteoarthritis

This study is a randomized controlled trial to investigate conservative treatments for individuals with painful knee osteoarthritis (OA) that is isolated to the medial compartment (inside half) of the knee. The methods involve training individuals to walk with a consistent foot progression angle (angle that their feet point relative to the direction of walking). We expect that individuals participating in the study will have a reduction in knee pain over the course of the 52-week intervention.

Pharmacogenetics in Treatment Refractory Depression – Replication Study

Patients will either be randomized into a genetics-based treatment plan (Pharmacogenetics) or a control group (Treatment as Usual). The length of participation in this study is for 4 months. All participants will exit the study by the fourth month and return to usual care. We hope to learn whether a person’s genetic makeup (genotype) influences the effectiveness of prescribed medications and the side effects that come with medication use. Any patients who currently have primary symptoms of depression with or without episodes of mania/hypomania that has not responded well to current treatment may be eligible for this study.

PTSD and Hormone Study

We are researching the effects of a naturally-occurring hormone, administered by nasal spray, on PTSD symptoms.

* 3 visits to the Menlo Park Division of VAPAHCS:

One interview about your symptoms.

Two research sessions – complete computer tasks while we measure your heart rate, respiration, and other physical reactions. 

Earn up to $100 in gift cards for completion of all portions of the study.


PTSD Brain Imaging Study

The Palo Alto VA is testing a new theory of how PTSD is manifested in the brain and we need your help. Participants will be paid $50 for interviews and $50 for MRI scanning. Deployment to a warzone is required but a diagnosis of PTSD is not.

Repetitive Transcranial Magnetic Stimulation (rTMS) for Dementia

This study examines whether or not repetitive Transcranial Magnetic Stimulation (rTMS) can help improve memory function in Veterans with mild cognitive impairment and mild to moderate dementia likely related to Alzheimer’s disease.

rTMS in Alleviating Pain and Comorbid Symptoms of Gulf War Illness

Headaches (HA), muscle, and joint pain are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine-like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Likewise, depression carries a very high co-morbid rate (50%) in patients with chronic pain, and in GWV with GWI related chronic HA and body muscle and joint pain conditions (GWI-HAP). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long-term untoward psychosomatic and abusive side effects.

This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating pain and other co-morbid symptoms of GWI.

Sleepless Warriors: Improving sleep in Veterans with a history of concussion

Are you a Veteran?

Do you have trouble falling asleep or staying asleep?

Have you ever...

  • hit your head and felt dazed?
  • been knocked unconcious?
  • had a concussion or mild TBI

We are investigating non-drug therapies to improve sleep.

This study includes:

  • 6 individual therapy sessions
  • 3 at-home sleep studies
  • Reimbursement of up to $475

For more information about signing up for this study, please call: (650) 852-3426

Or visit our website: http://med.stanford.edu/sleepless-warriors


tN2O Study - Veterans with PTSD

Do you have symptoms of PTSD? Are you a Veteran with symptoms of Post-Traumatic Stress Disorder?
(e.g., re-experiencing a traumatic event, avoiding stressful situations, negative feelings, sleep problems, unable to relax)

You may be eligible to participate in a study to understand nitrous oxide's effects in PTSD.

For more information about the study, contact our study team at (650) 723-4095 or email veteranshealth@stanford.edu.

Study Location: VA Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, CA 94304

For general information about participants rights, contact: 1-866-680-2906.

Treatment for Obstructive Sleep Apnea to Increase CPAP Usage for Veterans with PTSD

Investigators hope to learn if Cognitive-Behavioral Therapy improves adherence to CPAP therapy in Veterans with Obstructive Sleep Apnea (OSA) and Posttraumatic Stress Disorder (PTSD).

VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers (VA CARES)

The goal of this project is to assess the potential benefits of dementia education and caregiver skill-building training. It is designed specifically for family members caring for Veterans with dementia of any cause.

Web-Delivered Acceptance & Commitment Therapy for Smokers with Bipolar Disorder

This is a research study of the effectiveness of web-based Acceptance and Commitment Therapy (ACT), WebQuit Plus, for smoking cessation in patients diagnosed with bipolar disorder. We look to compare WebQuit Plus to the standard web-based smoking cessation intervention. This study will be a randomized, controlled trial (RCT), in which we will compare WebQuit Plus to the standard web-based smoking cessation intervention. This study is expected to take 12 weeks, plus one follow-up visit occurring 4 weeks after the completion of the study.

WRIISC As A Model of Care for Chronic Multi-Symptom Illness

Many Gulf War Veterans experience problems with fatigue, trouble concentrating, and muscle/joint pain (also known as Gulf War Illness). We are conducting a study to learn how health care providers and Gulf War Veterans think and talk about Gulf War Illness.

The War Related Illness and Injury Study Centers in East Orange, NJ, Palo Alto, CA and Washington, DC are seeking Veterans who served in the Gulf War and who have an upcoming appointment with a health care provider at the primary care clinic or at the War Related Illness and Injury Study Center (WRIISC). Up to 200 Gulf War Veterans will participate in the study across these three sites.

If you qualify and choose to take part in the study, you will be asked to complete questionnaires before and after one of your upcoming medical appointments.  With your permission and the permission of your provider, that appointment will be audio-recorded.  The recording may be stopped at any time during the visit.  You will also complete questionnaire packets 4 weeks, 1 month, and 6 months after your medical appointment.  You will be paid up to $200 for your time for the study; $45 for completing questionnaires before and after your visit with your health care provider, $40 for each completed questionnaire packet at 4 weeks and 3 months, and $75 for completed questionnaire packets at 6 months.

Please contact the WRIISC and ask about the “Communication Study” at one of the three sites:
•    VA New Jersey Health Care System WRIISC:    800-248-8005
•    VA Palo Alto Health Care System WRIISC:    888-482-4376
•    Washington, DC VA Medical Center WRIISC:    800-722-8340