Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

April 25, 2023 updated by: National Institute for Medical Rehabilitation, Hungary

Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post-stroke Rehabilitation: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1121
        • National Institute for Medical Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Active Comparator: Control group
Received usual care (standard multidisciplinary stroke care) over 6 weeks.
Other: usual care
Usual care means received standard multidisciplinary stroke care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline on Beck Depression Inventory (BDI) at 6 weeks
Time Frame: Baseline and 6 weeks
Beck Depression Inventory (BDI) was used to assess severity of the depression with 21 items scored from 0 to 3 (hiv, Beck, 1961). Scores range from 0 to 63 with 0-9 representing normal value, 10-18 mild, 19-25 moderate, and ≥ 26 severe depression.
Baseline and 6 weeks
Change from 6 weeks on Beck Depression Inventory (BDI) at 3 months
Time Frame: 6 weeks and 3 months
Beck Depression Inventory (BDI) was used to assess severity of the depression with 21 items scored from 0 to 3 (hiv, Beck, 1961). Scores range from 0 to 63 with 0-9 representing normal value, 10-18 mild, 19-25 moderate, and ≥ 26 severe depression.
6 weeks and 3 months
Change from baseline on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 6 weeks
Time Frame: Baseline and 6 weeks
The Spielberger State-Trait Anxiety Inventory (STAI-X) was used to assess anxiety both as a state and trait. State anxiety was measured by STAI form X-1, requiring participants to answer questions about how they feel right now. Trait anxiety was measured by the STAI form X-2, requiring participants to answer questions about how they feel generally. Both scales (X-1, X-2) consist of 20 items scored from 1 to 4. Scores range from 20 to 80 with higher scores representing higher state or trait anxiety.
Baseline and 6 weeks
Change from 6 weeks on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 3 months
Time Frame: 6 weeks and 3 months
The Spielberger State-Trait Anxiety Inventory (STAI-X) was used to assess anxiety both as a state and trait. State anxiety was measured by STAI form X-1, requiring participants to answer questions about how they feel right now. Trait anxiety was measured by the STAI form X-2, requiring participants to answer questions about how they feel generally. Both scales (X-1, X-2) consist of 20 items scored from 1 to 4. Scores range from 20 to 80 with higher scores representing higher state or trait anxiety.
6 weeks and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 6 weeks
Time Frame: Baseline and 6 weeks
Five Facet Mindfulness Questionnaire (FFMQ) was used to assess mindfulness with 39 items scored from 1 to 5 with five subscales, including observing (8 items), describing (8), acting with awareness (8), nonjudging of inner experience (8), and nonreactivity to inner experience (7). Total scores range from 39 to 195 with higher scores representing higher mindfulness.
Baseline and 6 weeks
Change from 6 weeks on The Five Facet Mindfulness Questionnaire (FFMQ) at 3 months
Time Frame: 6 weeks and 3 months
Five Facet Mindfulness Questionnaire (FFMQ) was used to assess mindfulness with 39 items scored from 1 to 5 with five subscales, including observing (8 items), describing (8), acting with awareness (8), nonjudging of inner experience (8), and nonreactivity to inner experience (7). Total scores range from 39 to 195 with higher scores representing higher mindfulness.
6 weeks and 3 months
Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 6 weeks
Time Frame: Baseline and 6 weeks
Multidimensional Scale of Perceived Social Support (MSPSS) was used to assess perceived social support receives from 3 different sources: family, friends, and significant other. The original version of the MSPSS is a 12-item scale scored from 0 to 6. The validated Hungarian version consists of 10 items scored from 1 to 5. Scores range from 10 to 50 with higher scores representing higher perceived social support.
Baseline and 6 weeks
Change from 6 weeks on The Multidimensional Scale of Perceived Social Support Scale (MSPSS) at 3 months
Time Frame: 6 weeks and 3 months
Multidimensional Scale of Perceived Social Support (MSPSS) was used to assess perceived social support receives from 3 different sources: family, friends, and significant other. The original version of the MSPSS is a 12-item scale scored from 0 to 6. The validated Hungarian version consists of 10 items scored from 1 to 5. Scores range from 10 to 50 with higher scores representing higher perceived social support.
6 weeks and 3 months
Change from baseline on Touluose-Piéron test(TP) at 6 weeks
Time Frame: Baseline and 6 weeks
Touluose-Piéron (TP) was used to assess sustained attention. This paper-pencil test consists of small boxes that have lines oriented in different directions, distributed in columns and rows. The task of the test is to examine the boxes and to mark those matching 4 model boxes, as quickly as possible within a limited time. Noted scores: the number of correct answers (CA), errored boxes (E), and omitted boxes (O). The Global Index of Attention and Perception (GIAP) is calculated by: CA- (E + O). Higher scores represent higher sustained attention.
Baseline and 6 weeks
Change from 6 weeks on Touluose-Piéron test(TP) at 3 months
Time Frame: 6 weeks and 3 months
Touluose-Piéron (TP) was used to assess sustained attention. This paper-pencil test consists of small boxes that have lines oriented in different directions, distributed in columns and rows. The task of the test is to examine the boxes and to mark those matching 4 model boxes, as quickly as possible within a limited time. Noted scores: the number of correct answers (CA), errored boxes (E), and omitted boxes (O). The Global Index of Attention and Perception (GIAP) is calculated by: CA- (E + O). Higher scores represent higher sustained attention.
6 weeks and 3 months
Change from baseline on Fugl-Meyer Assessment (FMA) at 6 weeks
Time Frame: Baseline and 6 weeks
Fugl-Meyer Assessment (FMA) is a clinician-measured instrument used to assess sensorimotor impairment in patients with post-stroke. It assess motor functioning, sensation, balance, joint range of motion and joint pain. The current study applied only the domain of the motor function (in the upper and lower extremities), and balance. The 57 items scored on a 3-point ordinal scale from 0 to 2, with a higher score representing less impairment. The motor score (M) ranges from 0 to 100; upper extremity (UE) 33 items with scores ranging from 0 to 66, lower extremity (LE) 17 items with scores ranging from 0 to 34. Balance 7 items scores from 0 to 14.
Baseline and 6 weeks
Change from 6 weeks on Fugl-Meyer Assessment (FMA) at 3 months
Time Frame: 6 weeks and 3 months
Fugl-Meyer Assessment (FMA) is a clinician-measured instrument used to assess sensorimotor impairment in patients with post-stroke. It assess motor functioning, sensation, balance, joint range of motion and joint pain. The current study applied only the domain of the motor function (in the upper and lower extremities), and balance. The 57 items scored on a 3-point ordinal scale from 0 to 2, with a higher score representing less impairment. The motor score (M) ranges from 0 to 100; upper extremity (UE) 33 items with scores ranging from 0 to 66, lower extremity (LE) 17 items with scores ranging from 0 to 34. Balance 7 items scores from 0 to 14.
6 weeks and 3 months
Change from baseline on Functional Independence Measure (FIM) at 6 weeks
Time Frame: Baseline and 6 weeks
Functional Independence Measure (FIM) was used to assess the level of independence in basic activities of daily living. FIM is a clinician-measured instrument consisting of 13 motor and 5 cognitive items scored from 1 to 7. The higher the score, the more independent the patient. Scores from 1 to 5 indicate a need for assistance. The total score ranges from 18 and 126; the motor subscale score ranges from 13 to 91, and the cognitive subscale score ranges from 5 to 35.
Baseline and 6 weeks
Change from 6 weeks on Functional Independence Measure (FIM) at 3 months
Time Frame: 6 weeks and 3 months
Functional Independence Measure (FIM) was used to assess the level of independence in basic activities of daily living. FIM is a clinician-measured instrument consisting of 13 motor and 5 cognitive items scored from 1 to 7. The higher the score, the more independent the patient. Scores from 1 to 5 indicate a need for assistance. The total score ranges from 18 and 126; the motor subscale score ranges from 13 to 91, and the cognitive subscale score ranges from 5 to 35.
6 weeks and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute for Medical Rehabilitation, Hungary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gábor Fazekas, MD habil PhD, National Institute for Medical Rehabilitation, Hungary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60371-2/2018/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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