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

NCT02797509 | Completed

• 1 other identifier: 2016P001190
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The current study has the following objectives:

1. 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. 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.

Conditions

Neurological Disorder

Keywords

Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (8)

• 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)

• 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)

• 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)

Other Outcomes (3)

• Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU

  Baseline (week 0)

• Credibility Questionnaire

  Baseline (week 0)

• Prior Mental Health Questionnaire

  Baseline (week 0)

Study Arms (2)

Psychosocial Skills-Based Intervention

EXPERIMENTAL

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.

Behavioral: Psychosocial Skills-Based Intervention

Minimally Enhanced Usual Care (MEUC)

NO INTERVENTION

Those in the MEUC will continue with their current care. This may include meeting with nurses, physical therapist, medical doctors, and other members of the stroke patient's medical team. Treatment as usual may also involve administration of Selective Serotonin Reuptake Inhibitors (SSRIs) to those patients with motor problems. They will also received a pamphlet with educational information on stroke and recovery

Interventions

Psychosocial Skills-Based Intervention BEHAVIORAL

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.

Psychosocial Skills-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 32509320 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 13, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)