Impact of Mindfulness on Psychological Well-being of Stroke Survivors and Their Caregivers

NCT03910855 | Completed DMC

• 1 other identifier: 201711-00071
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study will employ a randomized control design. Stroke survivors and family caregivers will be recruited for the study, and randomized either to receive mindfulness-based intervention or health education. Both programs consist of 4 2-hour sessions. Participants of the mindfulness-based intervention (MBI) will be taught and guided in practice of psychosocial interventions that are focused on (1) stress management and coping skills, (2), body awareness and movement, (3) feelings of empathy and compassion and (4) motivation for rehabilitation. Participants of the health education program (HEP) will learn and discuss topics related to self-care and post-stroke management. Measures will be administered prior to and on completion of the intervention, and at 3-month follow-up. They will be used to assess symptoms associated with depression, anxiety, stress, perceived quality of life and participant characteristics such as personality variables.

Conditions

Stroke; Stress; Anxiety; Depression

Keywords

Mindfulness; Stroke Survivors; Caregivers

Outcome Measures

Primary Outcomes (6)

• Cohen Perceived Stress Scale, PSS

  A 10-item measure evaluating the perception of stress.

  An average of 1 Month

• Centre for Epidemiologic Studies Depression Scale (CES-D)

  A 20-item measure for epidemiological research on depression.

  An average of 1 Week

• Stroke Specific Quality of Life Scale (SS-QOL)

  A 49-item self-report questionnaire designed to measure the heath related quality of life specific to stroke survivors across 12 domains.

  An average of 1 month

• Stroke Impact Scale (SIS)

  A 64-item questionnaire that assesses across 8 domains

  An average of 1 week

• Short-Form-36 (SF-36)

  A 36-item self-report survey of health, including physical and mental health. Higher scaled scores reflect better quality of health.

  A range from 4 to 52 weeks

• The State-Trait Anxiety Inventory, STAI

  The STAI is a commonly used measure of trait and state anxiety.

  State: Current state, Trait: An average of 1 month

Secondary Outcomes (3)

• Zarit Burden Inventory (ZBI)

  An average of 1 month

• The Big Five Personality Inventory, BFI

  An average of 1 month

• Five Facet Mindfulness Questionnaire, FFMQ

  An average of 1 month

Study Arms (2)

Mindfulness Based Intervention

EXPERIMENTAL

The mindfulness-based intervention consists of four 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to stroke survivors and their family caregivers. Participants will be provided handouts for the information covered during these talks and discussions.

Behavioral: Mindfulness Based Intervention

Health Education Program

ACTIVE COMPARATOR

The health education program consists of four 2-hour sessions covering various health topics (e.g. diet, nutrition and exercise) that pertain to stroke survivors. Participants will be provided handouts for the information covered during these talks and discussions.

Other: Health Education Program

Interventions

Mindfulness Based Intervention BEHAVIORAL

The mindfulness-based intervention consists of four 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to stroke survivors and their family caregivers. Participants will be provided handouts for the information covered during these talks and discussions.

Mindfulness Based Intervention

Health Education Program OTHER

The health education program consists of four 2-hour sessions covering various health topics (e.g. diet, nutrition and exercise) that pertain to stroke survivors. Participants will be provided handouts for the information covered during these talks and discussions.

Health Education Program

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors and/ or their
• Family Caregivers
• Comprehends and provides consent independently

You may not qualify if:

• Cognitively impaired individuals with a MMSE score of less than 20, and a MoCA score of less than 23.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Stroke; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kinjal Doshi, PhD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will be randomized to receive either a Mindfulness-based Intervention (MBI) or a Health Education Program (HEP). The intervention is for 4 weeks. Measures will be administered prior to and on completion of the intervention, and at 3-month follow-up.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: April 10, 2019
• Study Start: September 1, 2018
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

SG (1)