Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers

Browse trials for

• Brain Injuries 2,113

Keywords

• Psychiatry
• Dyads
• Patients
• Caregivers
• Psychosocial

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 126 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Study arms

• 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

• 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.

Interventions

• BehavioralRecovering 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

Primary outcomes

1. Feasibility of Recruitment (Ability to Recruit Dyads)

   Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled

   Time frame: Baseline

2. 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

   Time frame: Feasibility of program delivery will be measured at 6 weeks

3. Credibility and Expectancy Questionnaire

   This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy.

   Time frame: Baseline

4. Client Satisfaction Questionnaire

   This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.

   Time frame: post intervention (6 weeks after baseline)

Secondary outcomes

1. 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.

   Time frame: baseline to posttest to 3 months follow up

2. Post Traumatic Checklist

   The PTSD CheckList - Civilian Version measures symptoms of post traumatic stress and determines diagnoses. Scores range from 17-85. Higher scores indicate more severe stress.

   Time frame: baseline to posttest to 3 months follow up

3. Measures of Coping Style Part A

   The MOCS-A measures various coping strategies such as relaxation or adaptive thinking. Scores range from 0 to 52, and higher scores indicate greater self-perceived proficiency with these skills.

   Time frame: baseline to posttest to 3 months follow up

4. 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.

   Time frame: baseline to post test to 3 months follow up

5. Dyadic Relationship Scale

   The Dyadic Relationship Scale (DRS) has 2 sub scales that assess dyadic strains and dyadic positive interaction. Scales on each sub scale range from 1 to 4, with higher scores indicating great severity of the relevant construct.

   Time frame: Baseline, post treatment, 3-month follow-up

Baseline characteristics

Publications

• 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. PubMed 34498896 ↗
• 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. PubMed 33052404 ↗

Study documents

• Protocol and statistical analysis plan · Aug 6, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No