Can Stroke Patients and Their Caregiver Benefit From Additive Mindfulness Training

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Mindfulness, MBSR Other
    Intervention Desc: Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B
    ARM 1: Kind: Experimental
    Label: stroke patients and caregivers
    Description: 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Wolf Motor Function Test 20min
Primary Motor Activity LOG (MAL) Time of performance: ca. 15 min
Primary Assessment of Motor and Process Skills (AMPS) 50min
Primary ASPA (Attention and Performance Self-Assessment) 5min
Primary WHOQoL-BREF (for patients and caregivers) 20 min
Primary EQ-5D 5 min
Primary Pictorial Representation of Illness and Self Measure (PRISM) (patients and caregivers) 10min
Primary Burden Scale of family caregivers BSFC (Häusliche Pflegeskala) only caregivers 10min
Secondary Semi-structured Interview (patients and caregivers) 60min

Sponsors