StrokeNCT05844722
Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation
A study testing Mindfulness-based intervention therapy in people with Stroke and Rehabilitation, run by National Institute for Medical Rehabilitation, Hungary at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Rehabilitation, Mindfulness
- What is being tested?
- Mindfulness-based intervention therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteHungary
- Study dates
- 4 Feb 2019to 27 Sep 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Rehabilitation, Mindfulness
- Being tested
- Mindfulness-based intervention therapy, usual care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based intervention therapyBehavioural
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.
usual careOther
Usual care means received standard multidisciplinary stroke care
| Study group | Role | What they receive |
|---|---|---|
| MBCT group | Experimental | 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. Receives: Behavioral: Mindfulness-based intervention therapy |
| Control group | Active comparator | Received usual care (standard multidisciplinary stroke care) over 6 weeks. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
Secondary outcomes (10)
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start4 Feb 2019
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Medical Rehabilitation, Hungary
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gábor Fazekas, MD habil PhD, Principal investigator, National Institute for Medical Rehabilitation, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844722
- Sponsor's protocol ID
- 60371-2/2018/EKU
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post-stroke Rehabilitation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05844722
- Acronym / sponsor ID
- 60371-2/2018/EKU
- Conditions
- Stroke, Rehabilitation, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National Institute for Medical Rehabilitation, HungaryOther government
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT group | Experimental | Behavioral: Mindfulness-based intervention therapyThe 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. |
| Control group | Active comparator | Other: usual careReceived usual care (standard multidisciplinary stroke care) over 6 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based intervention therapyMindfulness-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. | Behavioural | MBCT group |
| usual careUsual care means received standard multidisciplinary stroke care | Other | Control group |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 6 weeks
Time frame: 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
Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 6 weeks
Time frame: 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
Change from baseline on Touluose-Piéron test(TP) at 6 weeks
Time frame: Baseline and 6 weeks
Change from 6 weeks on Touluose-Piéron test(TP) at 3 months
Time frame: 6 weeks and 3 months
Change from baseline on Fugl-Meyer Assessment (FMA) at 6 weeks
Time frame: Baseline and 6 weeks
Change from 6 weeks on Fugl-Meyer Assessment (FMA) at 3 months
Time frame: 6 weeks and 3 months
Change from baseline on Functional Independence Measure (FIM) at 6 weeks
Time frame: Baseline and 6 weeks
Change from 6 weeks on Functional Independence Measure (FIM) at 3 months
Time frame: 6 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gábor Fazekas, MD habil PhD principal investigator
National Institute for Medical Rehabilitation, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention therapy in people with Stroke and Rehabilitation, run by National Institute for Medical Rehabilitation, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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 6 May 2023. 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 Hungary. 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?
Change from baseline on Beck Depression Inventory (BDI) at 6 weeks (time frame: Baseline and 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.