Receptive Music Therapy for the Treatment of Depression

NCT ID: NCT00644527

Last Updated: 2008-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-07-31

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

Conditions

Depression

Keywords

depression; music; sound; randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Purpose designed music and sound listening program

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Purpose designed music and sound listening program

Intervention Type: OTHER

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.

3

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

Group Type: SHAM_COMPARATOR

Sham music for depression

Intervention Type: OTHER

Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Receptive Sound and Music; Mozart

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Paracelsus Medizinische Privatuniversität, Forschungsprogramm MusikMedizin

Principal Investigators

Vera Brandes

Role: PRINCIPAL_INVESTIGATOR

Paracelsus Medizinische Privatunsiversität, Salzburg

Joachim E Fischer, Prof MD MSc

Role: STUDY_DIRECTOR

Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University

Locations

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

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 20689350 (View on PubMed)

Other Identifiers

MIPH-2008-MT-1

Identifier Type: -

Identifier Source: org_study_id