Clinical trial NCT05844722: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Mindfulness
Lead sponsor: National Institute for Medical Rehabilitation, Hungary
Sponsor class: OTHER_GOV
First posted: 2023-05-06
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline on Beck Depression Inventory (BDI) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on Beck Depression Inventory (BDI) at 3 months
timeFrame: 6 weeks and 3 months
measure: Change from baseline on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on The Spielberger State-Trait Anxiety Inventory (STAI-X) at 3 months
timeFrame: 6 weeks and 3 months
Secondary outcomes:
measure: Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on The Five Facet Mindfulness Questionnaire (FFMQ) at 3 months
timeFrame: 6 weeks and 3 months
measure: Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on The Multidimensional Scale of Perceived Social Support Scale (MSPSS) at 3 months
timeFrame: 6 weeks and 3 months
measure: Change from baseline on Touluose-Piéron test(TP) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on Touluose-Piéron test(TP) at 3 months
timeFrame: 6 weeks and 3 months
measure: Change from baseline on Fugl-Meyer Assessment (FMA) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on Fugl-Meyer Assessment (FMA) at 3 months
timeFrame: 6 weeks and 3 months
measure: Change from baseline on Functional Independence Measure (FIM) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from 6 weeks on Functional Independence Measure (FIM) at 3 months
timeFrame: 6 weeks and 3 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute for Medical Rehabilitation
Study officials:
affiliation: National Institute for Medical Rehabilitation, Hungary
name: Gábor Fazekas, MD habil PhD
role: PRINCIPAL_INVESTIGATOR
References: