Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers
- Conditions
- Neurological Disorder
- Interventions
- Behavioral: Psychosocial Skills-Based Intervention
- Registration Number
- NCT02797509
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychosocial Skills-Based Intervention Psychosocial Skills-Based Intervention Based on information from Phase I (semi-structured interviews), the investigators will develop a detailed psychosocial intervention manual. The intervention will be tailored consistent with American Heart Association (AHA) recommendations for stroke skills based interventions and will include 2 general and 4 specific modules (selected from 7 available). Generally, in the intervention, stroke patients and stroke caregivers will learn skills to cope and manage stroke-related stressors. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered within the NICU face to face and 4 tailored specific sessions to be delivered via live video using Vidyo. Participants in the intervention group will also receive treatment as usual.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States