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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03694678

Collaborator

(none)

122

Enrollment

Location

Arms

21.3

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Brain Injuries	Behavioral: Recovering Together	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Oct 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	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
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.

Arm

Intervention/Treatment

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.

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

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.

Outcome Measures

Primary Outcome Measures

Feasibility of recruitment (ability to recruit dyads) [Baseline]
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Feasibility of intervention delivery (ability to deliver intervention to dyads) [Feasibility of program delivery will be measured at 6 weeks]
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Credibility and expectancy questionnaire [Baseline]
This measure will assess participants' belief that the intervention (or control) will be helpful.
Client Satisfaction Questionnaire [post intervention (6 weeks after baseline)]
This measure will assess participants' satisfaction with participation in the study.

Secondary Outcome Measures

Hospital Anxiety and Depression Scale [baseline to posttest to 3 months follow up]
Measures symptoms of emotional distress 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 [baseline to posttest to 3 months follow up]
Measures symptoms of post traumatic stress and determines diagnoses
Measures of Coping Style part A [baseline to posttest to 3 months follow up]
measures various coping strategies such as relaxation or adaptive thinking
Cognitive and Affective Mindfulness Scale revised [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients, 18 years or older
English fluency and literacy
Access to high speed internet for video sessions
Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate
Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury
Either patient or caregiver within the dyads screens in for depression, anxiety, and/or PTSD

Exclusion Criteria:

Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE).
Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.