An interventional study of Psychosocial Skills-Based Intervention in Neurological Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The current study has the following objectives:
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Eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria:
One or more of the following exclusion criteria will render a stroke patient (only) ineligible:
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
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
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.
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.
Time frame: 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.
Time frame: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Measure of Current Status (MOCS-A)
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.
Time frame: 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)
Measures the degree to which individuals experience their thoughts and feelings.
Time frame: 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)
Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
Time frame: 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)
Measures the patient's prior stroke status and stroke severity.
Time frame: 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)
Measures symptoms of anxiety and depression.
Time frame: 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)
Measures symptoms of posttraumatic stress disorder
Time frame: 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,
Study staff will collect information on patient's medical history and current medications to measure their mental health throughout the study.
Time frame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Barthel Index
Measures the patient's prior stroke status and stroke severity.
Time frame: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)
Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU
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.
Time frame: Baseline (week 0)
Credibility Questionnaire
Measures how much the participant believes the intervention will work.
Time frame: Baseline (week 0)
Prior Mental Health Questionnaire
This questionnaire asks ICU patients/caregivers to report any previous or current mental health conditions that they have been diagnosed with in the past.
Time frame: Baseline (week 0)
Plan to share: Undecided
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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