Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation

NCT05844722 | Completed

• 1 other identifier: 60371-2/2018/EKU
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation; Mindfulness

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 weeks and 3 months

Secondary Outcomes (10)

• Change from baseline on The Five Facet Mindfulness Questionnaire (FFMQ) at 6 weeks

  Baseline and 6 weeks

• Change from 6 weeks on The Five Facet Mindfulness Questionnaire (FFMQ) at 3 months

  6 weeks and 3 months

• Change from baseline on The Multidimensional Scale of Perceived Social Support Scale(MSPSS) at 6 weeks

  Baseline and 6 weeks

• Change from 6 weeks on The Multidimensional Scale of Perceived Social Support Scale (MSPSS) at 3 months

  6 weeks and 3 months

• Change from baseline on Touluose-Piéron test(TP) at 6 weeks

  Baseline and 6 weeks

Study Arms (2)

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.

Behavioral: Mindfulness-based intervention therapy

Control group

ACTIVE COMPARATOR

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

Other: usual care

Interventions

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.

MBCT group

usual care OTHER

Usual care means received standard multidisciplinary stroke care

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute for Medical Rehabilitation, Hungary: lead

Study Sites (1)

National Institute for Medical Rehabilitation

Budapest, 1121, Hungary

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gábor Fazekas, MD habil PhD

  National Institute for Medical Rehabilitation, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 6, 2023
• Study Start: February 4, 2019
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)