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
|Condition or disease||Intervention/treatment||Phase|
|Acute Brain Injuries||Behavioral: Recovering Together||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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
- 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
- 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.
- 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.
- Post Traumatic Checklist [ Time Frame: baseline to posttest to 3 months follow up ]Measures symptoms of post traumatic stress and determines diagnoses
- 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
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|