Neurological Disorder
Conditions
Keywords
Intensive Care Unit
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.
Interventions
BEHAVIORALPsychosocial Skills-Based Intervention
Subjects will attend group skills-based sessions once weekly (either in-person or via Vidyo) for 6 weeks and learn skills to cope and manage stroke-related stressors.
Sponsors
American Heart Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Demonstration of feasibility will be assessed by the number of individuals who drop out of the study prior to completing the post- intervention assessment and the rate of missed sessions. If drop-out rate or missed-session rate exceeds 25%, revisions to the intervention may be needed. |
| Client Satisfaction Questionnaire (CSQ-8) | Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures how satisfied the participant is with the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive and Affective Mindfulness Scale (CAMS) | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures the degree to which individuals experience their thoughts and feelings. |
| World Health Organization QOL Questionnaire (WHOQOL-BREF) | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns. |
| Modified Rankin Scale (mRS) | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures the patient's prior stroke status and stroke severity. |
| Measure of Current Status (MOCS-A) | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. |
| Posttraumatic Stress (PCL-S) | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures symptoms of posttraumatic stress disorder |
| Current psychotropic meds and comorbid medical conditions, | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study. |
| Barthel Index | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures the patient's prior stroke status and stroke severity. |
| Hospital Anxiety and Depression Scale (HADS) | Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26) | Measures symptoms of anxiety and depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Credibility Questionnaire | Baseline (week 0) | Measures how much the participant believes the intervention will work. |
| Prior Mental Health Questionnaire | Baseline (week 0) | This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past. |
| Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU | Baseline (week 0) | This questionnaire asks ICU patients/caregivers to report their age, gender, race, ethnicity, marital status, highest level of education, and primary employment status over the last 12 months. |
Countries
United States
Outcome results
None listed