An interventional study of Mindfulness-based intervention therapy and usual care in Stroke, Rehabilitation and Mindfulness, sponsored by National Institute for Medical Rehabilitation, Hungary. Completed at 1 site in Hungary. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by National Institute for Medical Rehabilitation, Hungary · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 93 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →National Institute for Medical Rehabilitation, Hungary is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Received usual care (standard multidisciplinary stroke care) over 6 weeks.
Other: usual care
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 care means received standard multidisciplinary stroke care
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks and 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks and 3 months
Plan to share: No
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National Institute for Medical Rehabilitation, Hungary