Trial document




drksid header

  DRKS00016616

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MUSED

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Background:
Depression is one of the most prevalent mental disorders worldwide with women being more affected than men. Depressive disorders are often accompanied by increased stress levels which can be monitored with specific biomarkers e.g. heart rate variability or the stress hormone cortisol.

Aim:
With the MUSED-study, we aim to investigate the effectiveness of music therapy in depressed women. The music therapy intervention focuses to the reduction of depressive symptoms and psychobiological stress.

Participants:
Adult women between 18 and 65 years with current depression are eligible for participation in this study. The number of participants amounts to a minimum of 74 women. Initially we have planned with a sample size of 66 participants. We have increased this number in order to strengthen the statistical meaningfulness of the results.

Study procedure:
Participants will be randomly assigned to either the intervention group (i.e. music therapy) or a waitlist control group (receiving the intervention after completion of all assessments). Participants will be asked to fill out questionnaires and to take part in psychobiological assessments to determine stress levels within their daily life (48-hours-pulse and saliva samples).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Introduction: People suffering from depression commonly show impaired emotion regulation and altered regulation of psychobiological stress systems. Initial studies indicate that music therapy can impact depressive symptoms and psychobiological mechanisms and may therefore contribute to an effective treatment of depression.

Objectives: We aim to investigate the effects of music therapy on observer-rated depression (Hamilton Depression Rating Scale). Furthermore, self-ratings (e.g. emotion regulation through music and stress perception) will be assessed. Moreover, we will examine the impact of the intervention on circadian biological rhythms in daily life. In particular, we will monitor the circadian rhythm of vagal tone indexed by heart rate variability (HRV) and of the hypothalamus-pituitary-adrenal (HPA) axis indexed by diurnal cortisol profile. Psychobiological assessments will be accompanied by an ecological momentary assessment (EMA).

Methods: 74 adult women between 18 and 65 years with a current depressive disorder will be eligible for participation. Participants will be randomly assigned to either the intervention group (music therapy + treatment as usual, TAU) or the control group (solely TAU).

Outcome measures: Self-report data will be collected before (pre), after (post) and 10 weeks after the end of intervention (follow-up). The observer-rated data and psychobiological data (48h HRV, 6 saliva samples each on two consecutive days) and the EMA will be measured before and after the intervention period. Additionally, all participants will complete a short inquiry weekly between the pre and post assessment. Both the psychological and the psychobiological data will be analyzed to detect interaction effects between the two study conditions over time.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

All non-personal data will be stored in the heiDATA Dataverse Network for an unlimited period of time and in pseudonymized form after regular completion of the research project.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016616
  •   2019/02/21
  •   [---]*
  •   yes
  •   Approved
  •   S-545/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F32.8 -  Other depressive episodes
  •   F32.9 -  Depressive episode, unspecified
  •   F33.0 -  Recurrent depressive disorder, current episode mild
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
  •   F33.8 -  Other recurrent depressive disorders
  •   F33.9 -  Recurrent depressive disorder, unspecified
  •   F34.1 -  Dysthymia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Treatment as usual + Music therapy (anamnestic interview + 10 weeks, weekly 120 minutes, group setting)
  •   Waitlist control group (10 weeks treatment as usual). The participants are offered to participate in music therapy after having finished all measurements.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

a) self-rated depression measured with Beck Depression Inventory II (pre, post, follow-up)
b) functionality of the hypothalamic-pituitary-adrenal axis indexed by diurnal cortisol pattern within days (pre, post)
c) changes in circadian heart rate variability measured with 48-hours-ECG (pre, post)
d) self-ratings of diverse psychological constructs in daily life to identify potential covariates via ecological momentary assessment (pre, post)

Measurement of b), c) and d) proceeds parallely.

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)

*self-rated stress will additionally be measured during the intervention phase (once a week)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/07/29
  •   74
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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).

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Psychosomatik
    • Mr.  Dr.  Marc  Jarczok 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Medizinische Psychologie
    • Ms.  M.A.  Christine  Gäbel 
    • Bergheimer Straße 20
    • 69115  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Medizinische Psychologie
    • Ms.  M.A.  Christine  Gäbel 
    • Bergheimer Straße 20
    • 69115  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Institut für Medizinische Psychologie am Zentrum für Psychosoziale Medizin, Universitätsklinikum Heidelberg
    • Bergheimer Straße 20
    • 69115  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Landesgraduiertenförderung
    • Seminarstr. 2
    • 69117  Heidelberg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Steffen Lohrer Stiftung
    • Mr. 
    • Albert-Ueberle-Straße 34
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.