Clinical trial NCT02797509: Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers
Official title: Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorder
Keywords: Intensive Care Unit
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The current study has the following objectives:

1. To determine additional stroke patient (SP) and stroke caregiver (SC) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess SP and SC preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention.
2. To develop, \[using the preliminary data and information from aim 1\], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, PTSD and decreased QoL in dyads at risk.


Eligibility criteria: Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:

* Age 18 or older
* English fluency and literacy
* Hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) OR primary stroke caregiver of a stroke patient currently admitted with an acute stroke
* Stroke patient or stroke caregiver screens in for depression and/or PTSD

One or more of the following exclusion criteria will render a stroke patient (only) ineligible:

* Stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary outcomes:
measure: Measure of Current Status (MOCS-A)
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: World Health Organization QOL Questionnaire (WHOQOL-BREF)
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Modified Rankin Scale (mRS)
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Posttraumatic Stress (PCL-S)
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Current psychotropic meds and comorbid medical conditions,
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
measure: Barthel Index
timeFrame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Other outcomes:
measure: Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU
timeFrame: Baseline (week 0)
measure: Credibility Questionnaire
timeFrame: Baseline (week 0)
measure: Prior Mental Health Questionnaire
timeFrame: Baseline (week 0)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bannon S, Lester EG, Gates MV, McCurley J, Lin A, Rosand J, Vranceanu AM. Recovering together: building resiliency in dyads of stroke patients and their caregivers at risk for chronic emotional distress; a feasibility study. Pilot Feasibility Stud. 2020 May 25;6:75. doi: 10.1186/s40814-020-00615-z. eCollection 2020.