Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being (SOM)

Singapore Health Services (SingHealth)

Status: Completed

Conditions: Stroke; Depression; Anxiety; Stress

Treatments: Behavioral: Waitlist - Mindfulness-Based Intervention; Behavioral: Mindfulness-Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03659409

2016/2361

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Mindfulness Based Intervention

Experimental group

Description:

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:

Behavioral: Mindfulness-Based Intervention

Treatment Waitlist Group

Other group

Description:

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.

Treatment:

Behavioral: Waitlist - Mindfulness-Based Intervention