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Completed

NCT Number: NCT05844722

Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Medical Rehabilitation

Budapest, 1121, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-based intervention therapy

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.

Usual Care

Other

Usual care means received standard multidisciplinary stroke care

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

National Institute for Medical Rehabilitation, Hungary

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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