Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

NCT ID: NCT03271788

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-31

Brief Summary

The main purpose of the study is to find out if MBSR (Mindfulness) in addition to occupational therapy, can improve the therapeutic results in stroke-patients and help relatives of stroke patients to improve their quality of life.

Detailed Description

The study seeks primarily to determine the effect of Mindfulness (conducted additionally to occupational therapy) on physical and mental capabilities of life of stroke patients.

Furthermore, we want to find out if Mindfulness has a positive impact towards the quality of life and the daily burden of stroke patients and their caregivers.

The overall purpose of this study is to evaluate the feasibility of the process-basis, resources-basis, management-basis, and scientific basis for a further larger study. We want to conduct an exploratory case study as an A-B Design in which the A-Phase is "only regular occupational therapy" (no additive intervention) and the B-Phase contains the "regular occupational therapy" and "MBSR" (Mindfulness-Course; intervention).

Four stroke patients and their closest relative will be included in the study (n=8).

The study is non-blinded and no randomised allocation will take place. We will compare the outcomes of Phase B with the outcomes of Phase A of every person.

The purpose of the exploratory case study is to analyse the feasibility of the study design that will be used in a subsequent research study.

The study will last 16 weeks; split into two parts of eight weeks (A Phase and B-Phase).

1. Baseline Measurement

If the patient and the caregivers are included into the study they perform several measurements and questionnaires:

• Measurements to assess physical capabilities (Patient)
• Measurement to assess attention (Patient)
• Measurements to assess Quality of life daily burden of illness and caregiving (Patient and Caregiver
• Semi structured Interviews (Patient and Caregiver)

2. A-Phase The stroke patient continues his/her regular occupational treatment for eight weeks.

The caregivers get no study-related treatment.

3. 2nd (Midterm)-Measurement Same procedure as the baseline measurement.

4. B-Phase (Intervention Phase) Within the B-Phase of the study, the participant gets Mindfulness Training (intervention) in addition to the regular occupational therapy.

Before Patients and Caregivers start the MBSR Course (Mindfulness) the get information from an experienced Mindfulness trainer about e.g. duration, contents of the course, etc. They have the opportunity to ask questions.

The course lasts eight weeks. The MBSR group meet every week for 2.5h. The participants will get "homework" that they to perform at home (1h per day). If the duration of practice is to burdensome for the participants, then they can talk to the MBSR-trainer about time reduction.

5. 3rd (Final) Measurement Same procedure as the baseline and second (Midterm-) measurement.

Conditions

Stroke; Relatives; Motor Disorder; Attention Deficit; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stroke patients and caregivers

Stroke patients will conduct two phases ( A-Phase: regular occupational therapy; B-Phase occupational therapy with additional mindfulness) Caregivers of the patients will conduct the MBSR Course (Mindfulness) together with their relatives (Phase B). In Phase A they will not receive any treatment.

Group Type: EXPERIMENTAL

Mindfulness, MBSR

Intervention Type: OTHER

Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B

Interventions

Mindfulness, MBSR

Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Adult stroke patients (outpatients) who gets regular occupational therapy
• Time after stroke at least 6 months
• Modified Rankin Scale ≥1≤ 4
• Mini Mental State ≥ 24

• Close relative who is primary in charge and bear the largest burden of the caregiving of the stroke patient

Exclusion Criteria

• Co-Morbidity (e.g. severe psychological, neurological disorders)
• Severe cognitive disorders
• Severe speech comprehension disorders
• Known or suspected drug, medication or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zurich University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Silke Neumann

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silke Neumann, MSC

Role: PRINCIPAL_INVESTIGATOR

Zurich University of Applied Sciences

Central Contacts

Silke Neumann, MSc

Role: CONTACT

neus@zhaw.ch

0041 58 934 49 76

Heidrun Becker, Prof

Role: CONTACT

heidrun.becker@zhaw.ch

0041 58 934 64 77

Other Identifiers

97106125033101

Identifier Type: -

Identifier Source: org_study_id