FORCE - Facing Our Risk of Cancer Empowered  University of South Florida

Healthy Mind Healthy You

Name of Principal Investigator and Institution

Andrew A. Nierenberg, MD
Massachusetts General Hospital
MOOD Patient Powered Research Network

Goals

This study will randomize participants to either eight sessions of online mindfulness-based treatment (“standard”) or a briefer, three-session online mindfulness-based treatment (“light”) to compare the treatments’ efficacy and acceptability across a wide range of conditions and special populations. Given the substantial time and effort associated with standard (eight to 12 sessions) treatments, it is of interest whether standard mindfulness treatment is indeed superior to shorter mindfulness treatment. It is also important to determine who responds better to which treatment (i.e., standard vs. light).

The importance of this topic has been recognized as one of the top priority areas for comparative effectiveness research by the Institute of Medicine, which recommended that researchers compare the effectiveness of mindfulness-based interventions (e.g., yoga, meditation, deep-breathing training) for treating anxiety and depression, pain, cardiovascular risk factors, and chronic diseases. The proposed dose-finding study can help patients, parents, and caregivers (as well as clinicians) know the best dose of mindfulness to manage stress and increase wellness, with a substantial impact on care.

This study will also leverage the already-established active and engaged patient and other stakeholder partners of each participating site, the patient-powered research networks (PPRNs). Specifically, we have created a governance structure for this study that consists of seven committees (steering, operations, stakeholder, information technology, safety, diversity, communication and dissemination) comprising all types of stakeholders and representing all of the PPRNs. Through this oversight, patients and other stakeholders will help make the implementation and dissemination of this study a success.

Status

The study proposal was approved for funding by PCORI in August 2016.

ABOUT’s Role

As a participating Patient Powered Research Network in the Healthy Mind Healthy You project, ABOUT will participate in recruitment of patients.

ABOUT is a Patient-Powered Research Network in PCORnet®,  the National Patient-Centered Clinical Research Network, an initiative funded by the Patient-Centered Outcomes Research Institute (PCORI).

The National Patient-Centered Clinical Research Network
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