Our Pilot Projects
Year 1 Pilot Projects
Written Exposure Therapy
- Ian Kronish, MD, MPH
Project Leader(s): Ian Kronish, MD, MPH
NIH Stage Model: Stage IB (Feasibility and Pilot Testing)
Study Description: Written Exposure Therapy (WET) represents a potentially scalable exposure-based intervention for CVD event survivors. WET is comprised of brief psychoeducation plus five 30-minute sessions at which patients are instructed to write about their memory of the traumatic CVD event with particular attention to the felt emotions and the meaning of the event. Acute CVD events are inherently different from other trauma exposures that promote CVD-related fear. As opposed to external threats (e.g., combat, physical/emotional abuse), CVD events represent ongoing internal somatic threats. Thus, WET for CVD patients requires adaptation to target current and ongoing cardiac threat perceptions, rather than solely memories of the index CVD event. It is also unclear whether CVD event survivors will accept exposure therapy, as few such patients currently seek treatment for CVD-associated distress and may be uninterested in psychological therapies in this context. Accordingly, we are testing the feasibility of conducting an RCT employing a modestly adapted WET intervention to usual care in CVD event survivors. As part of intervention development, we collaborated with the experts who developed WET at the National Center for PTSD in Boston (Drs. Sloan and Marx) to modify the WET protocol for CVD patients to have increased focus not just on fear from the index event, but also on ongoing fear of recurrence and interoceptive bias.
Office-Based Heart Rate Variability Training (HRVT)
- Jeffrey Birk, PhD
Project Leader(s): Jeffrey Birk, PhD
NIH Stage Model: Stage IA and IB
Study Design: This is a single-arm pilot study examining the feasibility of administering a single in-person session of HRVT to 10 acute coronary syndrome patients as determined by ability of patients to comprehend and follow the intervention procedures, as well as assessing patient satisfaction with HRVT.
Intervention Description: A growing body of research shows that heart rate variability training (HRVT) increases HRV and reduces symptoms of stress and anxiety with a large standardized effect size. The intervention is believed to restore autonomic balance by increasing activity in the vagus nerve. The current predominant version of HRVT involves asking people to practice breathing at the respiratory rate at which their variability in beat-to-beat heart rate (HR) is maximized. For many people, this rate tends to be 6 breaths/minute. Participants practice breathing at this rate with the goal of improving their post-training resting state HRV. We will provide patients with an external (e.g., visual) form of feedback about their otherwise largely inaccessible autonomic physiology (i.e., vagus nerve activity). HRVT involves showing participants their HRV by presenting them with a depiction of their rising and falling heart rate in real time on a computer monitor that changes as they practice the slow paced breathing technique.
Year 2 Pilot Projects
Home-Based Heart Rate Variability Training: The Care After Life-threatening Medical Events (CALME) Study
- Jeffrey Birk, PhD
Project Leader(s): Jeffrey Birk, PhD
NIH Stage Model: IA and IB
Study Design: This single arm pilot study seeks to build on the experience of the single session office-based HRVT pilot study to examine the feasibility, acceptability, appropriateness, and usability of a more intensive multi-session home-based HRV biofeedback training intervention in 10 patients with elevated cardiac anxiety after cardiac arrest. The data collected from participants as part of this feasibility pilot will influence the decision to continue to a stage II RCT.
Intervention Description: Participants will receive video-delivered training in how to use a heart rate monitoring device (Polar), warn around the chest, in conjunction with the Elite HRV application on their smartphone to do paced breathing at a rate intended to maximize HRV, and then will be expected to practice the paced breathing task 5-10 minutes for day for at least 5 days per week across 4 weeks. Participants will also have the option of learning how to do paced breathing in manner that is personalized according to their own biorhythm, an approach that is expected to maximize improvements in HRV and anxiety reduction.
Pilot Study of Stellate Ganglion Blockade to Reduce PTSD Symptoms in Cardiac Arrest Survivors: A Pilot Randomized Clinical Trial
- Sachin Agarwal, MD, MPH
Project Leader(s): Sachin Agarwal, MD, MPH
NIH Stage Model: IB
Study Design: We will conduct a pilot RCT in 15 cardiac arrest survivors to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA). Patients will be randomized in a 2:1 ratio to the SGB + psychoeducation intervention versus a sham-control.
Intervention Description: The intervention is a single stellate ganglion block (SGB) injection provided in combination with a single session of psychotherapy explaining the connection between cardiac anxiety, PTSD symptoms, and recovery after cardiac arrest. The SGB procedure involves injection of local anesthetic in and around the stellate ganglion (located at the base of the neck) to temporarily block its function. While the precise mechanisms by which temporary interruption of the cervical sympathetic chain influences PTSD are not well understood, a growing number of studies has shown that this procedure reduces PTSD symptoms. Due to the somatic nature of the intervention, this procedure may be less stigmatizing and more acceptable to patients than conventional psychotherapies.
Pilot Study of Acceptance and Mindfulness-Based Exposure Therapy (AMBET) in Cardiac Arrest Survivors with Elevated Posttraumatic Stress Disorder (PTSD) Symptoms
- Maja Bergman, MS
Project Leader(s): Maja Bergman, MS and Yuval Neria, PhD
NIH Stage Model: IA and IB
Study Design: The goal of this pilot study is to develop a de novo protocol for AMBET for cardiac arrest survivors, modeled after other forms of exposure therapy and to then determine the feasibility of enrolling 10 cardiac arrest survivors with elevated PTSD symptoms into a clinical trialcomparing an acceptance and mindfulness based exposure intervention with usual
Intervention Description: The intervention being studied is an 8-session acceptance and mindfulness enhanced exposure therapy intervention (~60-90minutes/session, 1x/week) delivered by Master’s or PhD-trained psychologists with experience in conducting trauma-focused psychotherapy. The goals of the treatment will be to reduce PTSD symptoms and hypervigilance to internal stimuli (i.e., interoceptive bias) and increase cardiovascular health behaviors (medication adherence, physical activity) following cardiac arrest. Sessions will be delivered to patients individually, preferably in person, but with an option for Zoom-hosted video visits if in-person visits are not feasible.
Interoceptive Bias Reduction Training
- Andrea Duran, PhD
Project Leader(s): Andrea Duran, PhD
NIH Stage Model: Stage 1A (Adaptation and Refinement of Existing Interventions)
Patients that survive acute CVD events can develop maladaptive hyperawareness and threatening interpretations of normal physiological signals, known as interoceptive bias. To our knowledge, no intervention has been developed specifically to reduce interoceptive bias in CVD event survivors. Thus, we are developing a de novo protocol for Interoceptive Bias Reduction Training (IBRT). We will model IBRT on Anxiety Sensitivity Amelioration Training (ASAT). ASAT combines psychoeducation about the acute effects of interoceptive anxiety on the body, with behavioral exercises that promote habituation to threatening interoceptive cues. To develop our IBRT intervention, we plan to replace behavioral exercises with actual physical activity on the hospital floor as a means of triggering real-world physiologic signals (e.g., faster HR and respiratory rate). We then plan to conduct preliminary testing of the protocol in groups of 5 ACS patients, with assessments of treatment credibility, acceptability, and compliance. We are also determining the feasibility of obtaining permission and finding the opportunity to conduct our IBRT training before patients are discharged from the hospital. We then plan to continue piloting our protocol in groups of 5 patients until we are satisfied that we have developed a robust protocol for Stage 1B testing, involving a randomized design.
Year 3 Pilot Projects
Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest: A Pilot Intervention Study (FAID Fear)
- Talea Cornelius, PhD
Project Leader(s): Talea Cornelius, PhD
NIH Stage Model: Stage IA & IB
Study Design: 15 partners of patients who have experienced a cardiac arrest will be randomized in a 2:1 ratio to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge. Patients will complete surveys at discharge and 30 days post-discharge. In addition to feasibility outcomes (rate of enrollment, retention, intervention acceptability), key outcomes measured at baseline and 30 days will include the 8-item fear subscale of the Cardiac Anxiety Questionnaire, post-traumatic stress symptoms as measured by the PCL-5, and aversive cognitions toward exercise.
Intervention Description: The present study will test the feasibility of a Family-Authored ICU-diary intervention to reduce fear of CA in patients’ partners, with the long-term goal of developing and implementing a large scale RCT to test whether fear reductions in family members improve patients’ mental wellbeing, health behaviors, and, ultimately, health outcomes. Following the methods of a RCT published in 2020, partners will receive a bound diary from a trained research assistant and a brief explanation of how to use the diary, including recommended frequency for writing and how to express themselves and its potential value to them and to patients.
A pilot chronotherapeutic intervention to improve sleep following acute coronary syndrome
- Ari Shechter, PhD
Project Leader(s): Ari Shechter, PhD
NIH Stage Model: Stage IA & IB
Study Design: The goal of this project is to conduct preliminary testing of a chronotherapeutic intervention targeting disturbed sleep in survivors of acute coronary syndrome (ACS). This is important because sleep disturbances are common in patients who experience ACS, and sleep disturbances after a medical event can contribute to the development of further psychological distress. Phase 1 of the study will be a single-arm open-label study of the home-based combined chronotherapy (CC) intervention in 5 post-ACS patients to primarily assess feasibility of enrollment and administering the intervention. If successful, this will be followed by Phase 2 of the study, which will be a pilot randomized clinical trial (RCT) in which 15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. We will examine the feasibility of administering the intervention for 1 month following an ACS event, and specifically, the acceptability, appropriateness, and usability of the intervention. We will also examine whether the intervention affects sleep, physical activity, cardiac anxiety, and psychological distress.
Intervention Description: The intervention being tested here is a “combined chronotherapy” (CC) that has two components: 1) exposure to morning bright light (bright light therapy, [BLT]) via a wearable light visor (Luminette) for 30 minutes after awakening, and 2) blocking out exposure to short-wavelength light by wearing blue-light blocking (BLB) glasses from 8:00pm to bedtime.
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
- Marie Parsons, PhD
Project Leader(s): Marie Parsons, PhD
NIH Stage Model: Stage I & II
Study Design: The purpose of this pilot study is to evaluate feasibility/acceptability and to provide an empirical evaluation of mechanistic target engagement and initial estimates of effect sizes for the clinical impact of a scalable Digital Cognitive Behavior Therapy (dCBT) intervention for generalized anxiety disorder (GAD) and negative health behaviors in a cardiovascular disease (CVD) population. The data collected from participants as part of this feasibility pilot will influence the decision to continue with a larger randomized clinical trial (RCT) powered for a direct focus on longer-term changes in CVD health behaviors that are associated with reductions in GAD-related worry and anxiety. We propose to enroll up to 5 participants in Phase 1, and 90 participants in Phase 2. Eligible participants will be those who have experienced an acute CVD event, have clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD‐7, and are age 18 or older. In Phase 1, 5 participants will complete up to four modules of dCBT. In Phase 2, participants will be randomly assigned to either the dCBT program or a waitlist (Control) condition with a 1.5:1 allocation (dCBT: Control) using a blocked (male, female) randomization sequence.
Intervention Description: Participants in the dCBT condition will be asked to complete up to four models of the dCBT intervention across 6 weeks. All participants will complete self-report assessments of affective symptoms, worry, quality of life, sleep, and health behaviors at Week 0 (baseline), Week 3 (mid-treatment), Week 6 (end of treatment), and Week 10 (follow-up). Participants in the control condition will receive access to the dCBT intervention after completing the Week 10 assessment.
Remote-delivered Mindfulness-Based Cognitive Therapy to Target Far of Recurrence among SCAD Survivors
- Christina Luberto, PhD
Project Leader(s): Christina Luberto, PhD
NIH Stage Model: Stage IA and Stage IB
Study Design: The goal of this pilot study is to explore the feasibility, acceptability, and changes in psychological and behavioral health outcomes of UpBeat-MBCT for SCAD survivors. The goal of the proposed project is to explore the feasibility of enrolling and retaining SCAD survivors into the intervention; the feasibility of completing the data collection procedures (surveys, daily diaries, actigraphy); the acceptability and effects of the intervention on psychological and behavioral health outcomes; and make intervention refinements. Our goal will be to enroll 16 SCAD survivors into this single-arm study. We will run two intervention groups sequentially such that the results from the first group will be used to inform refinements for further pilot testing in the second group.
Intervention Description: The intervention being studied is an 8-session group Mindfulness-Based Cognitive Therapy intervention, adapted for survivors of acute cardiac events (UpBeat-MBCT). There are 1.5-hour weekly sessions delivered by a trained master’s or PhD-level clinical psychologist or social worker with experience in MBCT, and approx. 20-30 minutes of home practice in between weekly sessions. The intervention is delivered via synchronous group videoconference (HIPPA-secure Zoom platform). The goals of the treatment will be to reduce fear of recurrence symptoms and mechanistic processes (e.g., interoceptive bias, intolerance of uncertainty) and increase cardiovascular health behaviors (sleep, physical activity) following spontaneous coronary artery dissection (SCAD). Sessions will be delivered in groups of approx. 6-8 participants along with the trained facilitator.