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Neurological DisorderNCT02797509

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

A study testing Psychosocial Skills-Based Intervention in people with Neurological Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neurological Disorder
What is being tested?
Psychosocial Skills-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Jul 2016to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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.
Being tested
Psychosocial Skills-Based Intervention
Keywords
Intensive Care Unit
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychosocial Skills-Based InterventionBehavioural

    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.

Study groups in NCT02797509
Study groupRoleWhat they receive
Psychosocial Skills-Based InterventionExperimentalBased 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.
Receives: Behavioral: Psychosocial Skills-Based Intervention
Minimally Enhanced Usual Care (MEUC)No interventionThose 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  2. Client Satisfaction Questionnaire (CSQ-8)

    Measures how satisfied the participant is with the intervention.

    Measured: Change between post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

Secondary outcomes (8)

  1. 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.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  2. Cognitive and Affective Mindfulness Scale (CAMS)

    Measures the degree to which individuals experience their thoughts and feelings.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  3. 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.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  4. Modified Rankin Scale (mRS)

    Measures the patient's prior stroke status and stroke severity.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  5. Hospital Anxiety and Depression Scale (HADS)

    Measures symptoms of anxiety and depression.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  6. Posttraumatic Stress (PCL-S)

    Measures symptoms of posttraumatic stress disorder

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  7. 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.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

  8. Barthel Index

    Measures the patient's prior stroke status and stroke severity.

    Measured: Change between Baseline (week 0), post-intervention (week 8), 3-month Follow Up (week 13), and 6-month Follow Up (week 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJun 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02797509
Sponsor's protocol ID
2016P001190
Status last verified
Aug 2018
First submitted
2 Jun 2016
Last updated
17 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Bannon S, Lester EG, Gates MV, McCurley J, Lin A, Rosand J, Vranceanu AM. Recovering together: building resiliency in dyads of stroke patients and their caregivers at risk for chronic emotional distress; a feasibility study. Pilot Feasibility Stud. 2020 May 25;6:75. doi: 10.1186/s40814-020-00615-z. eCollection 2020.

    PubMed 32509320

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial Skills-Based Intervention in people with Neurological Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02797509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.

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