Preventing Chronic Depression and PTSD in Stroke Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Family Caregivers
15 agosto 2018 aggiornato da: 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:
- 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.
- 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
15
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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Nessun intervento: 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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibility of the Intervention
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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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.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Client Satisfaction Questionnaire (CSQ-8)
Lasso di tempo: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures how satisfied the participant is with the intervention.
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Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Measure of Current Status (MOCS-A)
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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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.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Cognitive and Affective Mindfulness Scale (CAMS)
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the degree to which individuals experience their thoughts and feelings.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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World Health Organization QOL Questionnaire (WHOQOL-BREF)
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Modified Rankin Scale (mRS)
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the patient's prior stroke status and stroke severity.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures symptoms of anxiety and depression.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Posttraumatic Stress (PCL-S)
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures symptoms of posttraumatic stress disorder
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Current psychotropic meds and comorbid medical conditions,
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Barthel Index
Lasso di tempo: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Measures the patient's prior stroke status and stroke severity.
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Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Età, sesso, razza, etnia, stato civile, stato di istruzione e stato lavorativo dei pazienti/caregiver in terapia intensiva
Lasso di tempo: Basale (settimana 0)
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Questo questionario chiede ai pazienti/caregiver in terapia intensiva di riferire la loro età, sesso, razza, etnia, stato civile, livello di istruzione più alto e stato occupazionale primario negli ultimi 12 mesi.
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Basale (settimana 0)
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Questionario di credibilità
Lasso di tempo: Basale (settimana 0)
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Misura quanto il partecipante crede che l'intervento funzionerà.
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Basale (settimana 0)
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Prior Mental Health Questionnaire
Lasso di tempo: Baseline (week 0)
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This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.
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Baseline (week 0)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 luglio 2016
Completamento primario (Effettivo)
1 giugno 2018
Completamento dello studio (Effettivo)
1 agosto 2018
Date di iscrizione allo studio
Primo inviato
2 giugno 2016
Primo inviato che soddisfa i criteri di controllo qualità
7 giugno 2016
Primo Inserito (Stima)
13 giugno 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 agosto 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 agosto 2018
Ultimo verificato
1 agosto 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2016P001190
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Indeciso
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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