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

Massachusetts General Hospital1 site in 1 country15 target enrollmentJuly 2016

ConditionsNeurological Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurological Disorder
Sponsor: Massachusetts General Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Feasibility of the Intervention
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The current study has the following objectives:

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.
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.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

August 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Ana-Maria Vranceanu, PhD

Clinical Psychologist

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Feasibility of the Intervention

Time Frame: 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)

Time Frame: 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 Outcomes

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))
Barthel Index(Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26))
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))
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))
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))
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))
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))
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))