Emotional Distress Clinical Trial
Official title:
Recovering Together: Building Resiliency in Dyads of Patients With an Acute Brain Injury Admitted to the Neuroscience Intensive Care Unit and Their Informal Caregivers
The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.
The goals of this study are to: 1) demonstrate the efficacy of Recovering Together for improving self-reported emotional distress (primary outcome), and post traumatic stress, mindfulness, coping, social support and other relevant outcomes (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either the active intervention or educational control. The trial is single blinded (assessors, patients and staff). The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21 pilot study. Study clinicians will deliver 6, 30 minute sessions of active intervention or educational control (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. They will also complete measures of emotional distress weekly, as well as measures assessing home practice. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
| Active, not recruiting |
NCT06035003 -
Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility
|
N/A | |
| Not yet recruiting |
NCT06034613 -
The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments
|
N/A | |
| Enrolling by invitation |
NCT05113706 -
Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary?Resuscitation
|
||
| Not yet recruiting |
NCT06056232 -
Mechanisms of Mindfulness Intervention: Distress Tolerance Dose Manipulation
|
N/A | |
| Active, not recruiting |
NCT05600790 -
Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
|
N/A | |
| Not yet recruiting |
NCT06103149 -
The Role of Cognitive Flexibility in Mindfulness Intervention: a Functional Near-infrared Spectroscopy Study
|
N/A | |
| Not yet recruiting |
NCT06051929 -
Mechanism of Mindfulness Intervention for Emotional Distress: the Role of Cognitive Flexibility
|
N/A | |
| Not yet recruiting |
NCT06087484 -
The Effect of Mindfulness Intervention for Emotional Distress of Insomnia People
|
N/A | |
| Completed |
NCT05027113 -
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress
|
N/A | |
| Not yet recruiting |
NCT06059092 -
Evaluation of Three School-based Mental Health Preventive Interventions in France
|
N/A | |
| Enrolling by invitation |
NCT04635618 -
Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19
|
N/A | |
| Enrolling by invitation |
NCT04632082 -
Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19
|
N/A | |
| Completed |
NCT05510635 -
The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer
|
N/A | |
| Recruiting |
NCT05639465 -
Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children
|
N/A | |
| Completed |
NCT04958941 -
CUIDA-TE, an APP for the Emotional Management
|
N/A | |
| Not yet recruiting |
NCT06377709 -
A Mixed-methods Acceptability Study of ProACTive™ to Help Burns Patients Adjust to Changes to Appearance
|
N/A | |
| Not yet recruiting |
NCT06226467 -
Neurobehavioral Affective Control Training
|
N/A | |
| Recruiting |
NCT05548699 -
Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
|
||
| Completed |
NCT04816708 -
A Self-directed Mobile Mindfulness Intervention to Address Distress and Burnout in Frontline Healthcare Workers
|
N/A |