Music Therapy for Depression: A Randomized Controlled Trial to Evaluate Psychobiological Effects of Music Therapy on Depression in Adult Wome

Not Applicable

• Conditions: F32.0; F32.1; F32.2; F32.8; F32.9; F33.0; F33.1; F33.2; F33.8; F33.9

• Registration Number: DRKS00016616
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-21
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Participants will be included if they (a) are female, (b) are between 18 and 65 years old, (c) meet the criteria for a current depressive disorder (without psychotic symptoms) or dysthymia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), respectively, according to International Classification of Diseases (ICD) 10 codes: F32.0; F32.1; F32.3; F32.8; F32.9; F33.0; F33.1; F33.2; F33.8; F33.9; F34.1, (d) meet the criteria for at least a mild depression diagnosed with the observer-rating Hamilton Depression Rating Scale of Depression (HDRS) and (e) meet the criteria for at least a mild depression diagnosed with the self-rating Beck Depression Inventory (BDI-II). A remitted depression will not be eligible for participation.

Exclusion Criteria

Participants will be excluded if they (a) meet the DSM-IV criteria for severe mental disorders (schizophrenia, bipolar disorder, acute suicidal tendency, psychotic symptoms), (b) have a borderline personality disorder, (c) meet the criteria for substance abuse or acute addiction, or (d) participate or participated in another music therapy (currently or during the last three months).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for the proposed study is the decrease of depressive symptoms from pre to post intervention measured by the observer-rated Hamilton Depression Rating Scale.

Secondary Outcome Measures

Name	Time	Method
a) self-rated depression measured with Beck Depression Inventory II (pre, post, follow-up)<br>b) functionality of the hypothalamic-pituitary-adrenal axis indexed by diurnal cortisol pattern within days (pre, post)<br>c) changes in circadian heart rate variability measured with 48-hours-ECG (pre, post)<br>d) self-ratings of diverse psychological constructs in daily life to identify potential covariates via ecological momentary assessment (pre, post)<br><br>Measurement of b), c) and d) proceeds parallely.<br><br>e) further self-ratings of psychological constructs: stress*, emotion regulation through music, music preference, coping, quality of life, loneliness, social suport, evaluation of social systems (pre, post)<br><br>*self-rated stress will additionally be measured during the intervention phase (once a week)<br>