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Completed

NCT Number: NCT02797509

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

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.

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Key information

Conditions

Neurological Disorder Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2016
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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