Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being

NCT ID: NCT03659409

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-12
• Study Completion Date: 2018-12-31

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).

Detailed Description

Stroke survivors face many concerns, including the physical, psychological, cognitive and psychosocial consequences of stroke, as well as impaired function and quality of life. Also important for stroke survivors is the possibility of recurrence that may result in death and further disability. Survivors depend on their caregivers to provide assistance for daily living tasks, emotional support and taking on new roles and responsibilities with changing social dynamics, often causing long-term strain.

Mindfulness-based interventions (MBIs) are psychotherapeutic interventions which have been shown to improve psychological, physiological and psychosocial outcomes such as anxiety, depression, mental fatigue, blood pressure and overall quality of life. However, data is limited for stroke survivors and their caregivers, especially in Asians. This study will evaluate the impact of MBIs on the psychological well-being and perceived quality of life among stroke survivors and their family caregivers in Singapore.

This study employs a randomized treatment-waitlist crossover design with outcome measures administered before and after the intervention as well as at 3 months follow-up for the treatment group.

The intervention consists of 4 weekly 2-hour mindfulness 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 movement, (4) feelings of empathy and compassion. Pre- and post-intervention questionnaires will be conducted to assess symptoms associated with depression, anxiety, stress and perceived quality of life. Blood pressure and heart rate variability recordings before and after intervention will also be noted.

Conditions

Stroke; Stress; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness Based Intervention

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Intervention

Intervention Type: 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.

Treatment Waitlist Group

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.

Group Type: OTHER

Waitlist - Mindfulness-Based Intervention

Intervention Type: 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.

Interventions

Mindfulness-Based Intervention

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.

Intervention Type: BEHAVIORAL

Waitlist - Mindfulness-Based Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kinjal Doshi, PhD

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2016/2361

Identifier Type: -

Identifier Source: org_study_id