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

15 août 2018 mis à jour par: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Preventing Chronic Depression and PTSD in Patients With Stroke Admitted to the Neuroscience ICU 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

15

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Massachusetts General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Aucune 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of the Intervention
Délai: 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.
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)
Délai: 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.
Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Measure of Current Status (MOCS-A)
Délai: 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.
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)
Délai: 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.
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)
Délai: 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.
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)
Délai: 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.
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)
Délai: 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.
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)
Délai: 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
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,
Délai: 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.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Barthel Index
Délai: 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.
Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Âge, sexe, race, origine ethnique, état matrimonial, niveau d'instruction et statut professionnel des patients/aidants à l'USI
Délai: Base de référence (semaine 0)
Ce questionnaire demande aux patients/soignants des soins intensifs de déclarer leur âge, leur sexe, leur race, leur origine ethnique, leur état civil, leur niveau d'éducation le plus élevé et leur statut d'emploi principal au cours des 12 derniers mois.
Base de référence (semaine 0)
Questionnaire de crédibilité
Délai: Base de référence (semaine 0)
Mesure dans quelle mesure le participant pense que l'intervention fonctionnera.
Base de référence (semaine 0)
Prior Mental Health Questionnaire
Délai: 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.
Baseline (week 0)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Collaborateurs

American Heart Association

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2016

Achèvement primaire (Réel)

1 juin 2018

Achèvement de l'étude (Réel)

1 août 2018

Dates d'inscription aux études

Première soumission

2 juin 2016

Première soumission répondant aux critères de contrôle qualité

7 juin 2016

Première publication (Estimation)

13 juin 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2016P001190

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Indécis

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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