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

Primary Purpose

Acute Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovering Together
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Brain Injuries focused on measuring Psychiatry, Dyads, Patients, Caregivers, Psychosocial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recovering Together

Health Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of recruitment (ability to recruit dyads)
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)
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Credibility and expectancy questionnaire
This measure will assess participants' belief that the intervention (or control) will be helpful.
Client Satisfaction Questionnaire
This measure will assess participants' satisfaction with participation in the study.

Secondary Outcome Measures

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.
Post Traumatic Checklist
Measures symptoms of post traumatic stress and determines diagnoses
Measures of Coping Style part A
measures various coping strategies such as relaxation or adaptive thinking
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.
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.
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

Full Information

First Posted
September 28, 2018
Last Updated
September 7, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03694678
Brief Title
Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
Official Title
Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injuries
Keywords
Psychiatry, Dyads, Patients, Caregivers, Psychosocial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovering Together
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovering Together
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of recruitment (ability to recruit dyads)
Description
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Time Frame
Baseline
Title
Feasibility of intervention delivery (ability to deliver intervention to dyads)
Description
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Time Frame
Feasibility of program delivery will be measured at 6 weeks
Title
Credibility and expectancy questionnaire
Description
This measure will assess participants' belief that the intervention (or control) will be helpful.
Time Frame
Baseline
Title
Client Satisfaction Questionnaire
Description
This measure will assess participants' satisfaction with participation in the study.
Time Frame
post intervention (6 weeks after baseline)
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
baseline to posttest to 3 months follow up
Title
Post Traumatic Checklist
Description
Measures symptoms of post traumatic stress and determines diagnoses
Time Frame
baseline to posttest to 3 months follow up
Title
Measures of Coping Style part A
Description
measures various coping strategies such as relaxation or adaptive thinking
Time Frame
baseline to posttest to 3 months follow up
Title
Cognitive and Affective Mindfulness Scale revised
Description
Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.
Time Frame
baseline to post test to 3 months follow up
Title
Self-efficacy scale
Description
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.
Time Frame
baseline to post test to 3 months follow up
Title
Intimade bond measure
Description
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
Time Frame
baseline to post test to 3 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34498896
Citation
Bannon SM, Cornelius T, Gates MV, Lester E, Mace RA, Popok P, Macklin EA, Rosand J, Vranceanu AM. Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial. Health Psychol. 2022 Apr;41(4):268-277. doi: 10.1037/hea0001102. Epub 2021 Sep 9.
Results Reference
derived
PubMed Identifier
33052404
Citation
Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807.
Results Reference
derived

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

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