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

Acute Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694678
• Other study ID #: 2018P002187
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 11, 2020

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 11, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Brain Injuries
• Brain Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment (ability to recruit dyads)	Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled	Baseline
Primary	Feasibility of intervention delivery (ability to deliver intervention to dyads)	We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery	Feasibility of program delivery will be measured at 6 weeks
Primary	Credibility and expectancy questionnaire	This measure will assess participants' belief that the intervention (or control) will be helpful.	Baseline
Primary	Client Satisfaction Questionnaire	This measure will assess participants' satisfaction with participation in the study.	post intervention (6 weeks after baseline)
Secondary	Hospital Anxiety and Depression Scale	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.	baseline to posttest to 3 months follow up
Secondary	Post Traumatic Checklist	Measures symptoms of post traumatic stress and determines diagnoses	baseline to posttest to 3 months follow up
Secondary	Measures of Coping Style part A	measures various coping strategies such as relaxation or adaptive thinking	baseline to posttest to 3 months follow up
Secondary	Cognitive and Affective Mindfulness Scale revised	Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.	baseline to post test to 3 months follow up
Secondary	Self-efficacy scale	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.	baseline to post test to 3 months follow up
Secondary	Intimade bond measure	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	baseline to post test to 3 months follow up