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Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

Primary Purpose

Stroke, Rehabilitation, Mindfulness

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Mindfulness-based intervention therapy
usual care
Sponsored by
National Institute for Medical Rehabilitation, Hungary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute for Medical Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MBCT group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline on Beck Depression Inventory (BDI) at 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.
Change from 6 weeks on Beck Depression Inventory (BDI) at 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.
Change from baseline on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 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.
Change from 6 weeks on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 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.

Secondary Outcome Measures

Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 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.
Change from 6 weeks on The Five Facet Mindfulness Questionnaire (FFMQ) at 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.
Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 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.
Change from 6 weeks on The Multidimensional Scale of Perceived Social Support Scale (MSPSS) at 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.
Change from baseline on Touluose-Piéron test(TP) at 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.
Change from 6 weeks on Touluose-Piéron test(TP) at 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.
Change from baseline on Fugl-Meyer Assessment (FMA) at 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.
Change from 6 weeks on Fugl-Meyer Assessment (FMA) at 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.
Change from baseline on Functional Independence Measure (FIM) at 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.
Change from 6 weeks on Functional Independence Measure (FIM) at 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.

Full Information

First Posted
April 3, 2023
Last Updated
April 25, 2023
Sponsor
National Institute for Medical Rehabilitation, Hungary
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1. Study Identification

Unique Protocol Identification Number
NCT05844722
Brief Title
Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation
Official Title
Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post-stroke Rehabilitation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute for Medical Rehabilitation, Hungary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Received usual care (standard multidisciplinary stroke care) over 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention therapy
Intervention Description
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
Other
Intervention Name(s)
usual care
Intervention Description
Usual care means received standard multidisciplinary stroke care
Primary Outcome Measure Information:
Title
Change from baseline on Beck Depression Inventory (BDI) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on Beck Depression Inventory (BDI) at 3 months
Description
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.
Time Frame
6 weeks and 3 months
Title
Change from baseline on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 3 months
Description
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.
Time Frame
6 weeks and 3 months
Secondary Outcome Measure Information:
Title
Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on The Five Facet Mindfulness Questionnaire (FFMQ) at 3 months
Description
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.
Time Frame
6 weeks and 3 months
Title
Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on The Multidimensional Scale of Perceived Social Support Scale (MSPSS) at 3 months
Description
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.
Time Frame
6 weeks and 3 months
Title
Change from baseline on Touluose-Piéron test(TP) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on Touluose-Piéron test(TP) at 3 months
Description
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.
Time Frame
6 weeks and 3 months
Title
Change from baseline on Fugl-Meyer Assessment (FMA) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on Fugl-Meyer Assessment (FMA) at 3 months
Description
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.
Time Frame
6 weeks and 3 months
Title
Change from baseline on Functional Independence Measure (FIM) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from 6 weeks on Functional Independence Measure (FIM) at 3 months
Description
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.
Time Frame
6 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gábor Fazekas, MD habil PhD
Organizational Affiliation
National Institute for Medical Rehabilitation, Hungary
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Medical Rehabilitation
City
Budapest
ZIP/Postal Code
1121
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

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