Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers

Neurological Disorder Clinical Trial

Official title:

Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797509
• Other study ID #: 2016P001190
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Nervous System Diseases
• Neurological Disorder

Intervention

Behavioral:
• Psychosocial 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU	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.	Baseline (week 0)
Other	Credibility Questionnaire	Measures how much the participant believes the intervention will work.	Baseline (week 0)
Other	Prior Mental Health Questionnaire	This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.	Baseline (week 0)
Primary	Feasibility of the Intervention	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.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Primary	Client Satisfaction Questionnaire (CSQ-8)	Measures how satisfied the participant is with the intervention.	Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Measure of Current Status (MOCS-A)	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.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Cognitive and Affective Mindfulness Scale (CAMS)	Measures the degree to which individuals experience their thoughts and feelings.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	World Health Organization QOL Questionnaire (WHOQOL-BREF)	Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Modified Rankin Scale (mRS)	Measures the patient's prior stroke status and stroke severity.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Hospital Anxiety and Depression Scale (HADS)	Measures symptoms of anxiety and depression.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Posttraumatic Stress (PCL-S)	Measures symptoms of posttraumatic stress disorder	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Current psychotropic meds and comorbid medical conditions,	Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Secondary	Barthel Index	Measures the patient's prior stroke status and stroke severity.	Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)