Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

NCT ID: NCT05844722

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2022-09-27

Brief Summary

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The goal of this clinical trial is to investigate the efficacy of mindfulness-based cognitive therapy compared to usual care for stroke survivors undergoing inpatient rehabilitation.

Detailed Description

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It was hypothesized that group-based MBCT would lead to improving mood, mindfulness, social support, physical, and neurocognitive function; and that these improvements would be maintained over the 3-month follow-up period. Participants in the control group received only usual care, the intervention group were involved in MBCT intervention in addition to usual care. MBCT intervention was designed to consist of eight 1.5-hour group sessions over 6 consecutive weeks.

Conditions

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Stroke Rehabilitation Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBCT group

The intervention group were involved in MBCT intervention in addition to usual care. MBCT intervention was designed to consist of eight 1.5-hour group sessions over 6 consecutive weeks.

Group Type EXPERIMENTAL

Mindfulness-based intervention therapy

Intervention Type BEHAVIORAL

Mindfulness-based cognitive therapy consists of meditation techniques to stay in the present moment with acceptance (breathing exercises, body scan, gentle yoga, awareness of thoughts and feelings) and some aspects of cognitive therapy, and psycho-education.

Control group

Received usual care (standard multidisciplinary stroke care) over 6 weeks.

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Usual care means received standard multidisciplinary stroke care

Interventions

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Mindfulness-based intervention therapy

Mindfulness-based cognitive therapy consists of meditation techniques to stay in the present moment with acceptance (breathing exercises, body scan, gentle yoga, awareness of thoughts and feelings) and some aspects of cognitive therapy, and psycho-education.

Intervention Type BEHAVIORAL

usual care

Usual care means received standard multidisciplinary stroke care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* stroke patients with functional impairments
* confirmation of stroke by CT or MRI scan
* age between 18-90 years
* had adequate communication skills, cognitive and physical capacity to participate in study activities
* competence to provide informed consent

Exclusion Criteria

* severe cognitive impairment according to the Word List Learning Instrument (total score \<7)
* severe depression according to the Beck Depression Inventory (BDI) (total score\>25)
* history of severe mental illness (psychotic disorder, schizophrenia, severe depression, bipolar disorder, PTSD, suicidal tendencies)
* the current change in the antidepressant therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Medical Rehabilitation, Hungary

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gábor Fazekas, MD habil PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute for Medical Rehabilitation, Hungary

Locations

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National Institute for Medical Rehabilitation

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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60371-2/2018/EKU

Identifier Type: -

Identifier Source: org_study_id

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