Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being

NCT03659409 | Completed DMC

• 1 other identifier: 2016/2361
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of mindfulness-based interventions on psycho-social and physiological well-being among stroke survivors and their family caregivers. This study will employ a treatment wait-list cross-over design, with half the participants randomized to receive the intervention first (treatment group), while the other half receives the interventions 2 months following the end of the treatment phase (wait-list group).

Conditions

Stroke; Stress; Anxiety; Depression

Keywords

Mindfulness; Stroke Survivors; Caregivers

Outcome Measures

Primary Outcomes (5)

• Cohen Perceived Stress Scale

  A 10-item measure evaluating the perception of stress.

  Past 1 Month

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

  A 20-item measure for epidemiological research on depression.

  Past 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.

  Past 1 Month

• Stroke Impact Scale (SIS)

  A 64-item questionnaire that assesses across 8 domains

  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 the past 4 to 52 weeks

Secondary Outcomes (3)

• Zarit Burden Interview

  Past 1 Month

• Five Facet Mindfulness Questionnaire

  Past 1 Month

• Big Five Personality Inventory

  Past 1 Month

Other Outcomes (1)

• Mental Fatigue Scale (MFS)

  1 Month

Study Arms (2)

Mindfulness Based Intervention

EXPERIMENTAL

4 weekly 2-hour sessions. Participants will be introduced, taught and guided in practice of mindfulness-based interventions that are focused on their (1) breath, (2) senses, (3) body and bodily movements, (4) feelings of empathy and compassion.

Behavioral: Mindfulness-Based Intervention

Treatment Waitlist Group

OTHER

Participants will receive no intervention, except for a baseline follow-up at the start and again at the end of the first phase. 2 months after the end of the first intervention phase, participants in this group will receive the same mindfulness-based intervention for 4 weeks.

Behavioral: Waitlist - Mindfulness-Based Intervention

Interventions

Mindfulness-Based Intervention BEHAVIORAL

4 weekly 2-hour sessions. Participants will be introduced, taught and guided in practice of mindfulness-based interventions that are focused on their (1) breath, (2) senses, (3) body and bodily movements, (4) feelings of empathy and compassion.

Mindfulness Based Intervention

Waitlist - Mindfulness-Based Intervention BEHAVIORAL

Participants in this group will only receive the Mindfulness-Based Intervention 3-months after they have started the study and baseline measurements. While participants in the Intervention Arm are receiving the treatment, this group will receive No intervention for the first four weeks and will continue as treatment as usual until it is their turn to receive the Intervention.

Treatment Waitlist Group

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
• Family Caregivers
• Able to speak and understand English Fluently
• Comprehends and provides consent independently

You may not qualify if:

• Cognitively impaired individuals with a MMSE Score of less than 20, MoCA score of less than 23
• Depression and Anxiety Stress Scale Scores, DASS, Depression \>7, Anxiety \>8, and Stress \>13

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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to receive either the intervention or treatment as usual. The intervention is for 4 weeks, and 3 months from the start of the intervention, participants who were assigned to the treatment as usual group will receive the same intervention.

Study Record Dates

• First Submitted: May 13, 2018
• First Posted: September 6, 2018
• Study Start: May 12, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

SG (1)