Mindfulness-based Music Therapy in Blind Elderly Women

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05583695
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mindfulness; Music Therapy; Blind; Elderly; Mood	Behavioral: mindfulness-based music therapy; Behavioral: mindfulness-based therapy; Behavioral: routine care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mindfulness-based music therapy	Behavioral: mindfulness-based music therapy; eight weekly sessions with a combination of both mindfulness and music therapy
Experimental: mindfulness-based therapy	Behavioral: mindfulness-based therapy; eight weekly sessions of mindfulness
Active Comparator: routine care	Behavioral: routine care; eight weekly sessions of routine care

Outcome Measures

Primary Outcome Measures

1. Difficulties in Emotion Regulation Scale (DERS) [at baseline]

   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.

2. Difficulties in Emotion Regulation Scale (DERS) [In the 8th week from baseline]

   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.

Secondary Outcome Measures

1. Depression Anxiety Stress Scales-21 (DASS-21) [at baseline]

   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.

2. Depression Anxiety Stress Scales-21 (DASS-21) [In the 8th week from baseline]

   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.

3. Geriatric Depression Scale (GDS) [at baseline]

   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.

4. Geriatric Depression Scale (GDS) [In the 8th week from baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hong Kong Society for the Blind	Kowloon		Hong Kong

Sponsors and Collaborators

• The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT05583695
• Other Study ID Numbers: RS-KHAB-2020-003
• First Posted: Oct 18, 2022
• Last Update Posted: Oct 24, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 24, 2022