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

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ClinicalTrials.gov Identifier: NCT02797509
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, 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.

Condition or disease Intervention/treatment Phase
Neurological Disorder Behavioral: Psychosocial Skills-Based Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU and Their Family Caregivers
Actual Study Start Date : July 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Minimally Enhanced Usual Care (MEUC)
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



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Measure of Current Status (MOCS-A) [ Time Frame: 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.

  2. Cognitive and Affective Mindfulness Scale (CAMS) [ Time Frame: 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.

  3. World Health Organization QOL Questionnaire (WHOQOL-BREF) [ Time Frame: 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.

  4. Modified Rankin Scale (mRS) [ Time Frame: 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.

  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.

  6. Posttraumatic Stress (PCL-S) [ Time Frame: 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

  7. Current psychotropic meds and comorbid medical conditions, [ Time Frame: 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.

  8. Barthel Index [ Time Frame: 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.


Other Outcome Measures:
  1. Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU [ Time Frame: 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.

  2. Credibility Questionnaire [ Time Frame: Baseline (week 0) ]
    Measures how much the participant believes the intervention will work.

  3. Prior Mental Health Questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797509


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Heart Association
Investigators
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Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital

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Responsible Party: Ana-Maria Vranceanu, PhD, Clinical Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02797509     History of Changes
Other Study ID Numbers: 2016P001190
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Intensive Care Unit

Additional relevant MeSH terms:
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Depression
Nervous System Diseases
Behavioral Symptoms