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

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2023
INTERVENTION: 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, the patients will be randomized into one of the two arms. Arm 1: Control group; 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 questionnaires are performed: ‐Pittsburgh Sleep Quality Inde X(PSQI). ‐The Epworth Sleepiness Scale (ESS) ‐Insomnia Severity Inde X(ISI) ‐Generalized Anxiety Disorder 7 (GAD‐7) ‐Hamilton Scale (HAM‐D) ‐Beck Depression Inventory (BDI) ‐Maladaptive and Adaptive Coping Strategies Questionnaire (MAX‐R) ‐Comprehensive Inventory of Mindfulness Experiences (CHIME) ‐Global Assessment of Functioning (GAF) ‐Ruminating‐Reflection Questionnaire (RRQ) ‐Obsessive Compulsive Inventory‐Revised (OCI‐R) ‐Metacognitive Questionnaire (MCQ‐30) ‐Social Phobia Inventory (SPIN) ‐Quality of Life Globalitem (WHO‐QOL‐BREF) ‐Rosenberg Self‐Esteem Scale (RSES) After 17 days (+/‐ 1 day) calculated from t0, an interim test will be done at t1, using these questionnaires: ‐Pittsburgh Sleep Quality Inde X(PSQI) ‐The Epworth Sleepiness Scale (ESS) ‐Insomnia Severity Inde X(ISI) ‐Beck Depression Inventory (BDI) After 28 days (+/‐ 2 days), at t2 (post‐intervention), the baseline questionnaire diagnosis of t0 is performed. Finally, at t3, three weeks after t2, a follow‐up survey is performed using the baseline questionnaire diagnostic of t0. Daily sleep inde Xsurveys will take place using the smartwatch (FitBit). In addition, daily ques CONDITION: ; F41 ; F32 ; F33 ; F42 Depressive episode Obsessive‐compulsive disorder Other anxiety disorders Recurrent depressive disorder PRIMARY OUTCOME: 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). INCLUSION CRITERIA: Presence of ICD‐10 with F.32, F.33, F.51., F.41, F.42 diagnosis. SECONDARY OUTCOME: 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 person's overall level of functioning (t0, t2, t3). ; ; ‐Rumination‐Reflection Questionnaire (RRQ): This self‐assessment sheet measures the degree of rumination (t0, t2, t3). ; ; ‐The Expressions of Spirituality Inventory (ESI‐R): is a multidimensional measure of spirituality and has five subscales that include a wide variety of aspects of spirituality: (1) Cognitive Orientation towards Spirituality, (2) Experiential/Phenomenological Dimension, (3) Existential Well‐Being, (4) Paranormal Beliefs, and (5) Religiousness (t0, t2, t3). ; ; ‐Sleep history: The sleep history is intended to provide information about sleep patterns and the use of pharmacological substances (t0, t2, t3).
Epistemonikos ID: 7d0c872d0d7139ecc64d89c01f85057ecc876aaa
First added on: Feb 20, 2024