Receptive Music Therapy for the Treatment of Depression

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00644527
First received: March 20, 2008
Last updated: November 17, 2008
Last verified: November 2008
  Purpose

Depressive symptoms are highly prevalent in the population. According to data from a Zurich longitudinal study, the lifetime incidence rate for severe depressive symptoms is 95%. Not all persons with depressive symptoms, however, need psychotherapeutic, psychiatric or pharmaceutical treatment. Many people specifically or unspecifically use music to influence their mood and clinical evidence demonstrates that active involvement in music supports an individual's treatment success during psychiatric therapy. The gray area of depressive symptoms that do not require medical treatment, but which contribute to a considerable disturbance of an individual's quality of life and ability to work, is the focus of the proposed study.

The study investigates whether listening to specific music programs arranged to influence depressive symptoms for 30 minutes in the morning and 30 minutes in the evenings can result in improvement of an individual's symptoms, as compared to listening to no prescribed music or no music treatment at all. Of specific interest is the use of music in the evening, which may contribute to the achievement of restive sleep.

The study's objective is to determine if the utilization of two specific music therapies to treat depressive symptoms, compared to a waiting list control intervention and an intervention listening to Mozart over a 5 week period, leads to an improvement of the depressive pathology among patients with moderate depressive disorders or patients with dysthymia. The study is designed as a simple blinded placebo-controlled study.


Condition Intervention
Depression
Other: Purpose designed music and sound listening program
Other: Sham music for depression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: "Rezeptive Musiktherapie Bei Depression - Eine Randomisierte, Placebokontrollierte Studie" / Receptive Music Therapy in Depression: A Randomized Placebo-Controlled Trial

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Change of a composite measure including the Hamilton Depression Scale (double weighted), the Beck Depression Inventory (single weighted) and the HADS-D-scale (single weighted) between study entry and 5 / 10 and 15-week-follow-up. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (SF 36), Vital Exhaustion Brief Questionnaire, Primary outcome measure at 5 and 10 weeks. [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Listening to one of two different specific music programs (Group A), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.
Other: Purpose designed music and sound listening program
Listening to one of two different specific music programs (Group A and B), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.
Other Name: Receptive Sound and Music
Experimental: 2
Listening to one of two different specific music programs (Group B), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.
Other: Purpose designed music and sound listening program
Listening to one of two different specific music programs (Group A and B), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.
Other Name: Receptive Sound and Music
Sham Comparator: 3
Control I (Group C) : Listening 30 min in the morning and 30 min in the evening to unspecific music (Mozart) over 5 weeks.
Other: Sham music for depression
Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.
Other Name: Mozart
No Intervention: 4
Control II (Group D): Waiting list. - Each 50% of the subjects will be assigned randomly to either Group A (arm 1) and B (arm 2) after 5 weeks of waiting time.

Detailed Description:

Participants of this study will be recruited through radio and television programs on the topic of depressive symptomatology. The investigators assume that those who are undergoing a cycle of change between a stronger depressive mood and brightened spirits will be more likely to volunteer for study participation than those who are experiencing a period of stronger depressive mood. Consequently, we anticipate an improvement in depressive mood over the study period, even without therapy, for all participants as compared to study entry. To account for this effect, two control groups are included in the study design.

Although the anticipated effect size attributable to the specific music is relatively small, depressive symptoms are highly prevalent in the population. Therefore, from a public health perspective, even a small effect on depressive symptomology could make an important contribution to this problem as interventions could be easily designed to be applied in broad circles of the population. Furthermore, the use of specific music may be found to play a role in the future primary prevention of depressive symptoms in the population.

Sample size calculation based on on Cohen's d = 0.45. Total target for recruitment = 200 participants.

Potential participants will be targeted through advertisements on the radio and television. An internet website will be given during the radio or television advertisement. The website will only contain information about the study and an invitation to participate. Potential participants will be asked to apply by e-mail. The first 500 respondents will be sent a questionnaire in written form. Based on the estimated response rate and inclusion criteria, it is anticipated that 300 invitations for diagnostic interviews will be sent out in response to the received, completed questionnaires after the data has been imported and analyzed. From these 300 invitations, it is estimated that 200 individuals will agree to participation and will be further assessed as meeting the inclusion criteria. These 200 participants will be randomized to the intervention groups (n =100) and both control groups (n = 50 each).

Once enrolled in the study, participants will complete an advanced psychometric classification through the use of:

  • BDI Beck Depression Inventory (Version II),
  • HADS-D Hospital Anxiety and Depression Scale
  • SCL-90-R Symptom-Checklist by L.R. Derogatis
  • STAXI State-Trait Anger Expression Inventory
  • STAI-G X1 abd X2 State-Trait Anxiety Inventory
  • TAS-20 Toronto-Alexithymia-Scale
  • PSQI Pittsburgh Sleep Quality Index
  • ME Morningness/Eveningness Questionnaire (Horne and Ostberg)
  • Physiological measurements: heart rate variability measurements
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 18 to 70 years with a Goldberg Depression Test Score of 15 to 65

Exclusion Criteria:

  • Patients, who abuse alcohol
  • Patients, with diseases as a consequence of alcohol abuse
  • Patients under psychiatric treatment because of psychoses
  • Patients with a Goldberg Depression Test Score of < 15 or > 65.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644527

Locations
Austria
Psychocardiology, 2. Med. Dep., Hanusch-Krankenhaus, Heinrich Collin-Str. 30
Vienna, Austria, A - 1140
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Vera Brandes Paracelsus Medizinische Privatunsiversität, Salzburg
Study Director: Joachim E Fischer, Prof MD MSc Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vera Brandes, Paracelsus Medizinische Privatuniversität, Forschungsprogramm MusikMedizin
ClinicalTrials.gov Identifier: NCT00644527     History of Changes
Other Study ID Numbers: MIPH-2008-MT-1
Study First Received: March 20, 2008
Last Updated: November 17, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Heidelberg University:
depression
music
sound
randomized controlled trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014