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Trial record 1 of 1 for:    NCT03694678
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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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ClinicalTrials.gov Identifier: NCT03694678
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2019
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.



Primary Outcome Measures :
  1. Feasibility of recruitment (ability to recruit dyads) [ Time Frame: Baseline ]
    Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled

  2. Feasibility of intervention delivery (ability to deliver intervention to dyads) [ Time Frame: 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

  3. Credibility and expectancy questionnaire [ Time Frame: Baseline ]
    This measure will assess participants' belief that the intervention (or control) will be helpful.

  4. Client Satisfaction Questionnaire [ Time Frame: post intervention (6 weeks after baseline) ]
    This measure will assess participants' satisfaction with participation in the study.


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: 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.

  2. Post Traumatic Checklist [ Time Frame: baseline to posttest to 3 months follow up ]
    Measures symptoms of post traumatic stress and determines diagnoses

  3. Measures of Coping Style part A [ Time Frame: baseline to posttest to 3 months follow up ]
    measures various coping strategies such as relaxation or adaptive thinking

  4. 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.

  5. 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.

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694678


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ana-Maria Vranceanu, PhD, Director of Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03694678    
Other Study ID Numbers: 2018P002187
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Psychiatry
Dyads
Patients
Caregivers
Psychosocial
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries