Music for the Mind: Sound stimulation to improve sleep quality in a clinical setting with psychiatric patients - a randomized controlled trial.

Music for the Mind: Sound stimulation to improve sleep quality in a clinical setting with psychiatric patients - a randomized controlled trial. - SOUND SLEEP

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031217

Enrollment

Registered

2023-04-27

Start date

2023-06-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F41 F32 F33 F42

Interventions

Group 1: Intervention Group: Music for the Mind After the patients have been informed about the study and have signed the consent form, screening is performed. In case of a PSQI inheritance of >5, th

Arm 2: Intervention group. Patients receive an MP3 player, noise-cancelling headphones, and a smartwatch (FitBit) at t0. Also, at t0, baseline questionnaire diagnostics consisting of the following q

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Presence of ICD-10 with F.32, F.33, F.51., F.41, F.42 diagnosis.

Exclusion criteria

Exclusion criteria: uncorrected hearing impairment, deafness, acute psychosis, severe neurologic disorder

Design outcomes

Primary

Measure	Time frame
Improvement in sleep quality after four weeks was recorded using following scales and device: -Pittsburgh Sleep Quality Index (PSQI): a self-rated questionnaire to assess sleep quality (t0, t1, t2). As psychiatric disorders are often associated with sleep disturbances, the PSQI was designed to evaluate overall sleep quality in these clinical populations. Each of the questionnaire’s 19 self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. -The Epworth Sleepiness Scale (ESS) is a widely used, brief self-assessment questionnaire. The questionnaire measures an individual's general daytime sleepiness, specifically sleep propensity. Sleep propensity represents a ratio of sleep urge to wakefulness urge (t0, t1, t2). -Insomnia Severity Index (ISI): Designed as a brief screening tool for insomnia, the seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale (t0, t0.1, t0.2, t0.3, t1, t2). -Subjective evaluation of MFM and semi-structured interview questions: The questionnaire allows patients to evaluate the auditory training (t1).	—

Measure

Time frame

Improvement in sleep quality after four weeks was recorded using following scales and device: -Pittsburgh Sleep Quality Index (PSQI): a self-rated questionnaire to assess sleep quality (t0, t1, t2). As psychiatric disorders are often associated with sleep disturbances, the PSQI was designed to evaluate overall sleep quality in these clinical populations. Each of the questionnaire’s 19 self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. -The Epworth Sleepiness Scale (ESS) is a widely used, brief self-assessment questionnaire. The questionnaire measures an individual's general daytime sleepiness, specifically sleep propensity. Sleep propensity represents a ratio of sleep urge to wakefulness urge (t0, t1, t2). -Insomnia Severity Index (ISI): Designed as a brief screening tool for insomnia, the seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale (t0, t0.1, t0.2, t0.3, t1, t2). -Subjective evaluation of MFM and semi-structured interview questions: The questionnaire allows patients to evaluate the auditory training (t1).

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Secondary

Measure	Time frame
The patient's psychiatric symptom burden decreases, with improvements in the following questionnaires: -Obsessive Compulsive Inventory-Revised (OCI-R): The OCI-R is a self-report instrument designed to assess the severity of obsessive-compulsive symptomatology (t0, t2, t3). -Metacognitive Questionnaire (MCQ-30): Using 30 questions, the questionnaire measures dysfunctional metacognition based on Wells' model (t0, t2, t3). -Social Phobia Inventory (SPIN): the SPIN is a self-report instrument for self-assessment of social anxiety (t0, t2, t3). -Quality of Life Globalitem (WHO-QOL-BREF): the global item of the self-assessment questionnaire measures the quality of life (t0, t2, t3). -Rosenberg Self-Esteem Scale (RSES): The RSES is a self-report instrument that measures self-esteem (t0, t2, t3). -Generalized Anxiety Disorder 7 (GAD-7): A self-rating questionnaire to assess generalized anxiety disorder and symptom severity of generalized anxiety (t0, t2, t3). -Hamilton scale ( HAM-D): a self-report questionnaire to assess the severity of the depressive disorder (t0, t2, t3). -Beck Depression Inventory (BDI): a self-rating questionnaire to determine the severity of depressive symptomatology (t0, t2, t3). -(MAX-R): This questionnaire measures maladaptive and adaptive coping strategies (t0, t2, t3). -Questionnaire on daily sleep quality and listening experience. The results are recorded daily. -FitBit Sleep Index: the FitBit smartwatch measures heart rate, the time spent awake or restless, and sleep stages. The overall sleep score is a sum of your scores using three components: sleep duration, sleep quality, and restoration, for a total score of up to 100. The scores are provided daily. -Comprehensive Inventory of Mindfulness Experiences (CHIME): the CHIME is a self-report instrument for self-assessment of different aspects of mindfulness (t0, t2, t3). -Global Assessment of Functioning (GAF): The GAF is a self-report instrument used to assess a p	—

Measure

Time frame

The patient's psychiatric symptom burden decreases, with improvements in the following questionnaires: -Obsessive Compulsive Inventory-Revised (OCI-R): The OCI-R is a self-report instrument designed to assess the severity of obsessive-compulsive symptomatology (t0, t2, t3). -Metacognitive Questionnaire (MCQ-30): Using 30 questions, the questionnaire measures dysfunctional metacognition based on Wells' model (t0, t2, t3). -Social Phobia Inventory (SPIN): the SPIN is a self-report instrument for self-assessment of social anxiety (t0, t2, t3). -Quality of Life Globalitem (WHO-QOL-BREF): the global item of the self-assessment questionnaire measures the quality of life (t0, t2, t3). -Rosenberg Self-Esteem Scale (RSES): The RSES is a self-report instrument that measures self-esteem (t0, t2, t3). -Generalized Anxiety Disorder 7 (GAD-7): A self-rating questionnaire to assess generalized anxiety disorder and symptom severity of generalized anxiety (t0, t2, t3). -Hamilton scale ( HAM-D): a self-report questionnaire to assess the severity of the depressive disorder (t0, t2, t3). -Beck Depression Inventory (BDI): a self-rating questionnaire to determine the severity of depressive symptomatology (t0, t2, t3). -(MAX-R): This questionnaire measures maladaptive and adaptive coping strategies (t0, t2, t3). -Questionnaire on daily sleep quality and listening experience. The results are recorded daily. -FitBit Sleep Index: the FitBit smartwatch measures heart rate, the time spent awake or restless, and sleep stages. The overall sleep score is a sum of your scores using three components: sleep duration, sleep quality, and restoration, for a total score of up to 100. The scores are provided daily. -Comprehensive Inventory of Mindfulness Experiences (CHIME): the CHIME is a self-report instrument for self-assessment of different aspects of mindfulness (t0, t2, t3). -Global Assessment of Functioning (GAF): The GAF is a self-report instrument used to assess a p

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Countries

Germany

Contacts

Public ContactAmir H. Yassari

Universitätsklinikum Hamburg-Eppensorf, Station für Zwangs- und Angststörungen

a.yassari@uke.de+4915222827161

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026