DepressionNCT00644527
Receptive Music Therapy for the Treatment of Depression
A study testing Purpose designed music and sound listening program in people with Depression, run by Heidelberg University at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Purpose designed music and sound listening program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2008to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years with a Goldberg Depression Test Score of 15 to 65
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Psychocardiology, 2. Med. Dep., Hanusch-Krankenhaus, Heinrich Collin-Str. 30
Vienna, A - 1140
About this study
Official title: "Rezeptive Musiktherapie Bei Depression - Eine Randomisierte, Placebokontrollierte Studie" / Receptive Music Therapy in Depression: A Randomized Placebo-Controlled Trial
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.
Read the 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
- Being tested
- Purpose designed music and sound listening program, Sham music for depression
- Keywords
- depression, music, sound, randomized controlled trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purpose designed music and sound listening programOther
Also called Receptive Sound and Music
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.
Sham music for depressionOther
Also called Mozart
Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Other: Purpose designed music and sound listening program |
| 2 | Experimental | 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. Receives: Other: Purpose designed music and sound listening program |
| 3 | Sham comparator | Control I (Group C) : Listening 30 min in the morning and 30 min in the evening to unspecific music (Mozart) over 5 weeks. Receives: Other: Sham music for depression |
| 4 | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks
Secondary outcomes (1)
Quality of life (SF 36), Vital Exhaustion Brief Questionnaire, Primary outcome measure at 5 and 10 weeks.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Vera Brandes, Principal investigator, Paracelsus Medizinische Privatunsiversität, SalzburgJoachim E Fischer, Prof MD MSc, Study director, Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644527
- Sponsor's protocol ID
- MIPH-2008-MT-1
- Status last verified
- Nov 2008
- First submitted
- 20 Mar 2008
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20689350
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Rezeptive Musiktherapie Bei Depression - Eine Randomisierte, Placebokontrollierte Studie" / Receptive Music Therapy in Depression: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00644527
- Acronym / sponsor ID
- MIPH-2008-MT-1
- Conditions
- Depression
- Keywords
- depression, music, sound, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Purpose designed music and sound listening programListening 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. |
| 2 | Experimental | Other: Purpose designed music and sound listening programListening 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. |
| 3 | Sham comparator | Other: Sham music for depressionControl I (Group C) : Listening 30 min in the morning and 30 min in the evening to unspecific music (Mozart) over 5 weeks. |
| 4 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 70 years with a Goldberg Depression Test Score of 15 to 65
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purpose designed music and sound listening programAlso: Receptive Sound and MusicListening 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 | 1, 2 |
| Sham music for depressionAlso: MozartListening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks. | Other | 3 |
Primary outcome
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
1 secondary outcome
Quality of life (SF 36), Vital Exhaustion Brief Questionnaire, Primary outcome measure at 5 and 10 weeks.
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2008.
- Derived from this study: PubMed 20689350Brandes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Brandes principal investigator
Paracelsus Medizinische Privatunsiversität, Salzburg
Joachim E Fischer, Prof MD MSc study director
Mannheim Insitute of Public Health, Mannheim Medical Faculty, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purpose designed music and sound listening program in people with Depression, run by Heidelberg University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00644527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2008.