Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ana-Maria Vranceanu, PhD，Massachusetts General Hospital

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

August 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility of recruitment (ability to recruit dyads)[ Time Frame: Baseline ]

Feasibility of recruitment will be determined by reporting number of dyads Number dyads who agree to participate

Feasibility of intervention delivery (ability to delivery intervention to dyads)[ Time Frame: Feasibility of program delivery will be measured at 6 weeks ]

Number of dyads who complete the post-intervention assessment.

Credibility and expectancy questionnaire[ Time Frame: Baseline ]

This measure will assess participants' belief that the intervention (or control) will be helpful.

Client Satisfaction Questionnaire[ Time Frame: post intervention (6 weeks after baseline) ]

This measure will assess participants' satisfaction with participation in the study.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Hospital Anxiety and Depression Scale[ Time Frame: baseline to posttest to 3 months follow up ]
Measures symptoms of depression and anxiety and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.
Post Traumatic Checklist[ Time Frame: baseline to posttest to 3 months follow up ]
Measures symptoms of post traumatic stress and examines diagnoses
Measures of Coping Style[ Time Frame: baseline to posttest to 3 months follow up ]
measures various coping strategies such as relaxation or adaptive thinking
Cognitive and Affective Mindfulness Scale revised[ Time Frame: baseline to post test to 3 months follow up ]
Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.
Self-efficacy scale[ Time Frame: baseline to post test to 3 months follow up ]
Measures beliefs in own ability to manage stress and daily life situations. The scale has 10 items and ranges from 10 to 40, with higher scores indicating higher self efficacy.
Intimade bond measure[ Time Frame: baseline to post test to 3 months follow up ]
measures care and intimacy between the 2 members of the dyad. The scale has 24 items and ranges from 0 to 71 with higher scores indicating more intimate and caring relationship between the dyad members

Descriptive Information

Brief Title ^ICMJE

Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers

Official Title ^ICMJE

Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers

Brief Summary

The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.

Detailed Description

The investigators aim to improve the care of patients (pts) admitted to the Neuroscience Intensive Care Unit (NICU) and their family caregivers (cgs) by conducting a pilot feasibility randomized controlled trial (RCT; N=80 dyads; 60 completers) of the dyadic resiliency program ("Recovering Together") to prevent chronic emotional distress in both pts and their cgs. Eligible dyads include adult, English speaking pts with acute neurological injury (ANI) admitted to the NICU, cleared medically and cognitively for participation by the nursing team, and their primary cgs. Dyads who are randomly assigned to "Recovering Together" will receive 6 manualized sessions (2 in person at hospitalization and 4 through live video after discharge, to reduce burden and facilitate access to care) led by a clinical psychologist. Dyads who are randomly assigned to the attention placebo educational control condition will receive 6 manualized sessions (2 in person and 4 through live video with a clinical psychologist), modeled after the Recovering Together program that will control for the dose of the intervention and support from therapist. Dyads will complete assessment surveys before, after the intervention and 3 months later. Clinical data on demographics, diagnosis, ANI severity, and any medical complications will be extracted from electronic health records.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Recovering Together
The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions

Study Arms

Experimental: Recovering Together
Dyads who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, dyads will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
No Intervention: Health Education
Patients randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

160

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 31, 2020

Estimated Primary Completion Date

August 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Male and female out patients, age 50 years or older - Have a nonmalignant chronic pain for more than 3 months - Has a documented MCI diagnosed by a neurologist - Able to perform a 6-minute walk test - Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose - Cleared by a medical doctor for study participation Exclusion Criteria: - Diagnosed with a medical illness expected to worsen in the next 6 months (e.g. malignancy) - Serious mental illness or instability for which hospitalization may be likely in the next 6 months - Current suicidal ideation reported on self-report - Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder - Current substance abuse or dependence and current substance use disorder, within the past 6 months - Practice of yoga/meditation, or other mind body techniques that elicit the RR, once per week for 45 minutes or more within the last 3 months or less - Regular use of Fitbit in the last 3 months - Unable to walk without use of assistance (e.g. walk, cane, wheelchair)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ana-Maria Vranceanu, PhD，Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Massachusetts General Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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