Mindfulness-based Music Therapy in Blind Elderly Women

Study Overview
=================
Brief Summary
-----------------
This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.

Official Title
-----------------
Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women

Conditions
-----------------
Mindfulness, Music Therapy, Blind, Elderly, Mood

Intervention / Treatment
-----------------
* Behavioral: mindfulness-based music therapy
* Behavioral: mindfulness-based therapy
* Behavioral: routine care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female blind with visual acuity (the best eye) of 20/400 or below aged 65 years or above cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12 able to speak Cantonese Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mindfulness-based music therapy<br> | Behavioral: mindfulness-based music therapy<br>* eight weekly sessions with a combination of both mindfulness and music therapy<br>|
| Experimental: mindfulness-based therapy<br> | Behavioral: mindfulness-based therapy<br>* eight weekly sessions of mindfulness<br>|
| Active Comparator: routine care<br> | Behavioral: routine care<br>* eight weekly sessions of routine care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties in Emotion Regulation Scale (DERS) | Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions. | at baseline | 
| Difficulties in Emotion Regulation Scale (DERS) | Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions. | In the 8th week from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Anxiety Stress Scales-21 (DASS-21) | Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms. | at baseline | 
| Depression Anxiety Stress Scales-21 (DASS-21) | Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms. | In the 8th week from baseline | 
| Geriatric Depression Scale (GDS) | Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms. | at baseline | 
| Geriatric Depression Scale (GDS) | Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms. | In the 8th week from baseline |