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Receptive Music Therapy for the Treatment of Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Purpose designed music and sound listening program
Sham music for depression
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring depression, music, sound, randomized controlled trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Psychocardiology, 2. Med. Dep., Hanusch-Krankenhaus, Heinrich Collin-Str. 30

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

No Intervention

Arm Label

1

2

3

4

Arm Description

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.

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.

Control I (Group C) : Listening 30 min in the morning and 30 min in the evening to unspecific music (Mozart) over 5 weeks.

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.

Outcomes

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.

Secondary Outcome Measures

Quality of life (SF 36), Vital Exhaustion Brief Questionnaire, Primary outcome measure at 5 and 10 weeks.

Full Information

First Posted
March 20, 2008
Last Updated
November 17, 2008
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00644527
Brief Title
Receptive Music Therapy for the Treatment of Depression
Official Title
"Rezeptive Musiktherapie Bei Depression - Eine Randomisierte, Placebokontrollierte Studie" / Receptive Music Therapy in Depression: A Randomized Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, music, sound, randomized controlled trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Control I (Group C) : Listening 30 min in the morning and 30 min in the evening to unspecific music (Mozart) over 5 weeks.
Arm Title
4
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Purpose designed music and sound listening program
Other Intervention Name(s)
Receptive Sound and Music
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham music for depression
Other Intervention Name(s)
Mozart
Intervention Description
Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Quality of life (SF 36), Vital Exhaustion Brief Questionnaire, Primary outcome measure at 5 and 10 weeks.
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Brandes
Organizational Affiliation
Paracelsus Medizinische Privatunsiversität, Salzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joachim E Fischer, Prof MD MSc
Organizational Affiliation
Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
Official's Role
Study Director
Facility Information:
Facility Name
Psychocardiology, 2. Med. Dep., Hanusch-Krankenhaus, Heinrich Collin-Str. 30
City
Vienna
ZIP/Postal Code
A - 1140
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
20689350
Citation
Brandes V, Terris DD, Fischer C, Loerbroks A, Jarczok MN, Ottowitz G, Titscher G, Fischer JE, Thayer JF. Receptive music therapy for the treatment of depression: a proof-of-concept study and prospective controlled clinical trial of efficacy. Psychother Psychosom. 2010;79(5):321-2. doi: 10.1159/000319529. Epub 2010 Aug 2. No abstract available.
Results Reference
derived

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Receptive Music Therapy for the Treatment of Depression

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