Our Projects
Behavioral RCT Projects
iHeart 2: Impact of a theory-informed, patient activation implementation strategy on depression treatment optimization amongst depressed cardiac patients: iHeart DepCare
- Cardiac patients with depressive symptoms gain access to electronic depression education and activation tool
- PI: Nathalie Moise, MD, MS, FAHA
Project Leaders: Nathalie Moise, MD, MS and Siqin Kye Ye, MD, MS
NIH Stage Model: Stage V (Implementation and Dissemination)
Study Description: Nearly 1 out of every 5 coronary heart disease will have clinically significant depressive symptoms, which doubles the risk for cardiovascular mortality and reduces quality of life. In fact, late life events (cardiac events, loss of friends) can affect an aging person’s emotional well-being, placing them at increased risk for depression, which has been linked to Alzheimer’s and mortality. Several studies have now established that depression treatments like antidepressants, therapy, and exercise improve depressive symptoms and quality of life in cardiac patients. Programs like collaborative care models, which are programs for delivering depression treatment to cardiac patients in primary care, may even reduce the risk of cardiac events. Yet only 4-6% of patients are treated with medication and psychotherapy, which is a critical gap between evidence and practice. Our research has shown that depression screening alone is not enough to improve depressive symptoms and quality of life: Patients need to receive evidence-based treatments as well. In our review of the literature, we found several barriers to depression treatment uptake in cardiac patients. These include lack of patient knowledge of the link between depression and coronary heart disease, lack of symptom insight/awareness of treatments, low perceived efficacy of treatment, suboptimal socio-culturally appropriate treatment options, lack of communication between patients and physicians, and low self-efficacy. All of these contribute to low patient activation, a strong predictor of depression remission and engagement in healthy behaviors and a potential mechanistic target for improving depression treatment uptake and health behaviors alike. Informed by the Behavior Change Wheel, we developed a patient activation tool that links depression screening with psychoeducation, symptom insight, patient activation (around health behaviors and depression treatment), and preference-driven treatment selection support with linkage to therapeutic resources. Our study is supported by strong feasibility and pilot data suggesting acceptability, feasibility, and preliminary efficacy of our tool and need for additional motivational components (iHeart 1.0). Here, we will refine and evaluate a multi-component iHeart DepCare intervention in real world settings by conducting a provider-level cluster randomized control trial in which providers and their patients will be randomly assigned to a multi-component iHeart DepCare intervention vs. usual care at several primary care and cardiology clinics across our enterprise. Our primary outcome will be the proportion of their patients who initiate/optimize treatment for depression. Secondary outcomes will include effects on depressive symptoms, provider referral behaviors as well as several mechanistic measures (e.g., decisional conflict, patient activation and perceived barriers to treatment). Implementation outcomes will include reach, adoption, acceptability and appropriateness.
AMBET 2: Acceptance and Mindfulness-based Exposure Therapy (AMBET) for PTSD following Sudden Cardiac Arrest
- Patients with clinically elevated levels of PTSD symptoms following cardiac arrest receive mindfulness-based exposure therapy (AMBET) or Present Centered Therapy (PCT)
- PI: Maja Bergman, PhD
Project Leader(s): Maja Bergman, PhD and Yuval Neria, PhD
NIH Stage Model: II (Efficacy)
Study Description: 90 adult patients with clinically elevated PSTD symptoms after experiencing cardiac arrest will be enrolled into a randomized controlled trial (RCT) comparing acceptance and mindfulness-based exposure therapy (AMBET) versus participant-centered therapy (PCT).
Participants randomized to the AMBET intervention will meet with a study therapist for eight 90-minute video sessions over a 12-week period. AMBET is a cognitive-behavioral manualized treatment protocol specifically developed for survivors of cardiac arrest. Following psychoeducation about PTSD and cardio-protective health behaviors, therapists introduce participants to mindfulness practices for emotion regulation, stress reduction, and exposure to internal stimuli. This is followed by individually tailed in vivo exposures that evoke fear responses (e.g., hearing sirens, physical activity) to reduce avoidance responses; imaginal exposure; and composing a trauma narrative that participant and therapist process for adaptive meaning making. Homework exercises are assigned between sessions.
Participants randomized to PCT (the active control) will meet with the study therapist via video for 60 minutes on a weekly basis for 12 weeks. Homework will be assigned between sessions. Present-Centered Therapy (PCT) was originally developed as a manualized comparison for the non-specific psychotherapy effects in PTSD treatment. Treatment focus in PCT includes enhanced interpersonal connectedness, insight into current symptoms, and increased problem-solving skills. Techniques used include empathic listening and support from the therapist and education about the links between symptoms and daily problems. The treatment is based on client-centered principles such as empathy, unconditional positive regard, and congruence. It excludes trauma-focused components (exposure, cognitive restructuring of dysfunctional beliefs, processing of trauma memories).
