Major Depressive DisorderMTMDDRSNCT02925325
Music Therapy for Major Depressive Disorder Residual Symptoms
A study testing Music therapy and Usual Treatment in people with Major Depressive Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial summary
Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at the psychiatric clinic, have become a growing problem. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Music therapy and Usual Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2016to Jun 2017
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subsequent and file number at the National Institute of Psychiatry "Ramon de la Fuente" patients.
- Male or Female Patients.
- Age 20-45 years.
- Previous diagnosis of MDD according to DSM-IV.
- Presence of residual symptoms, with a score of ≤7 points in the HAM-D-21 and / or ≤9 points in BDI.
- Patients who agree to sign informed consent sheet.
- Patients without a psychotherapeutic treatment during the 8 weeks prior to baseline.
- Patients with any pharmacological antidepressant treatment in continuation phase or maintenance (Eg. SSRIs, benzodiazepines) with good adherence.
Who cannot join
- Patients with psychotic symptoms.
- Patients with suicidal risk.
- Patients with comorbid Axis I.
- Patients with comorbid Axis II as the primary diagnosis.
- Patients with any type of hearing chronic medical illness, neurological or (Eg. Hearing loss, tinnitus, etc.)
- Patients with addiction to any substance (except caffeine and nicotine).
- Patients with medical or psychological problems related to music (Eg. Amusia or musicogenic Epilepsy.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz
Mexico City, Mexico City, 14370
Jorge J Gonzalez Olvera, MD PhD, +5215515107370, jjgonz@gmail.com
Enrique O Flores Gutierrez, MD PhD, +525541605381, florese@imp.edu.mx
About this study
Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at the psychiatric clinic, have become a growing problem. Its presence is associated with a high probability of relapse / recurrence and disability, as determined by decreased performance and low quality of life. Their neglect has generated an increase in clinical and socioeconomic costs, alerting the need for research to provide treatment strategies. The application of different types of psychotherapy has been successful in abating SRD. The present study aims to evaluate the clinical changes related to the application of music therapy as a treatment of SRD, through a randomized controlled trial with two treatment arms trial. Music Therapy (MT) is a psychotherapy provided by specialized health professionals, and is defined as the clinical use of musical evidence-based interventions within a therapeutic relationship. MT treatment group will design an application schema of 8 sessions (2 hrs. Each) over a period of two months (one session per week). The control group will receive the Usual Treatment (TU) which corresponds to the usual clinical psychiatric treatment by the physician in the INPRF, with the same duration. The evaluation will be conducted with clinimetric testing at baseline, at the end of the track and after three months of treatment. This study seeks to identify the presence of SRD in a Mexican sample and explore a treatment designed for that purpose, also, show that the MT is a cost-effective implementation can become a new clinical option to extend the possibilities of assistance and deepen the investigation of this problem.
Read the detailed description
GENERAL PURPOSE:
To evaluate the clinical changes related to the application of music therapy as a treatment for Residual Symptoms of Depression.
SPECIFIC OBJECTIVES:
- Compare the pre and post treatment of residual symptoms by the HAM-D-21, BDI, SCL-90-R and CIDRS levels.
- Compare the change of pre and post treatment obtained by the instruments for quality of life (WHOQOL-BREF), functioning (GAF and PSP) and perceived stress (PSS) values.
METHOD
Design - A randomized controlled trial with two treatment arms: the experimental group Music Therapy (MT); and control group Usual (TU) treatment. MT treatment group will design and will be completed in a period of two months, with an outline of 8 sessions (one per week). The TU corresponds to the usual clinical psychiatric treatment (drug) assigned by the attending physician in the INPRF.
POPULATION - patients attending the outpatient department of the National Institute of Psychiatry "Ramon de la Fuente" between 20 and 45, considered in remission of major depressive disorder (MDD) (DSM-IV) score ≤7 be included points on the Hamilton Depression Scale of (HAM-D-21) and / or ≤9 points in the Beck Depression Inventory (BDI), which have had a positive response to drug treatment and / or remain with pharmacotherapy phase continuation or maintenance, and there report or detection of persistent residual symptoms.
In this research, both participants in the control group and the experimental group, remain drug therapy throughout the study according to the instructions of the attending physician, so the period and type of administration shall be the sole decision of the same. In any case this protocol assessments will be conducted as planned. In the case of any change in drug therapy researchers take note of it for consideration in the final results.
SAMPLE SIZE - According to calculations made, the sample size is 48 patients. With an allocation of 24 patients in each treatment (MT and UT). It is considered to recruit an approximate previous historical studies in SRD sample (Fava et al., 1996; Fava et al., 1998).
To calculate the sample size formula for "comparison of two proportions" (Fernández, 2001), which was used as follows:
Where:
n = subjects required in each of the samples
Za = Z value corresponding to the desired risk
Zb = Z value corresponding to the desired risk
p1 = Value of the proportion in the control group, placebo control or usual treatment.
p2 = Value of the proportion in the group of the new treatment, intervention or technique.
p = average of the two proportions p1 and p2
The following data were considered:
- a confidence level of 95% or safety was established.
- A power of 80%.
- the effectiveness of standard treatment in preventing relapse (Fava et al was set at 32%., 1996; Paykel et al., 1999; Fava et al., 1998; Teasdale et al., 2000; Ma \& Teasdale, 2004).
- was set at 70% of the desired effectiveness for MT in preventing relapse, considering the performance of psychotherapies reported (Fava et al., 1996; Paykel et al., 1999; Fava et al., 1998; Teasdale et al, 2000; Ma. \& Teasdale, 2004).
This accounted for 15% of subjects the possible loss of the sample according to the following formula:
Losses set to n = (1/1-R) shows
n = number of subjects lossless
R = expected loss ratio
- Conditions
- Major Depressive Disorder
- Being tested
- Music therapy, Usual Treatment
- Keywords
- Major depressive disorder, Music therapy, Residual symptoms
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Music therapy (MT) treatment focuses on the use of 2 techniques of intervention: receptive MT and active MT. The work of receptive application is described as the use of prerecorded music or executed by the music therapist with effect on the patient, without the latter's active involvement in the psychotherapeutic process of musical creation. While the active application, both the music therapist and patient are involved in musical creation, for example, the use of voice, body and musical instruments (Muñoz, 2008). Contemplate their psychotherapeutic possibilities in 3 different dimensions of patient: body, emotional and social work, as explained above. Treatment with MT, as in cognitive behavioral therapy, includes breathing exercises, stress-relaxation techniques, psychoeducation, and exercises for the management of irrational thoughts and erratic behavior patterns (Dobson and Dozois, 2010).
Usual TreatmentOther
It is the usual medical treatment that patients with major depressive disorder in remission but with residual symptom receives at the sponsor institution in a monthly basis.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Music therapy 8 weekly sessions Receives: Behavioral: Music therapy |
| Usual Treatment | Active comparator | It is the usual medical treatment. Receives: Other: Usual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Clinical Interview for Depression and Related Syndromes
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Secondary outcomes (5)
Symptom Checklist 90 Revised (SCL-90-R)
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Beck Depression Inventory
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
WHO Quality of Life-BREF (WHOQOL-BREF)
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Personal and social performance scale (PSP)
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Perceived stress scale (PSS)
Measured: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge J. González Olvera, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Investigators
- Enrique O Flores Gutierrez, MD PhD, Study chair, Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteJorge Julio González Olvera, MD PHD, Principal investigator, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925325
- Sponsor's protocol ID
- INPRF_MUS_THER_MDD
- Acronym
- MTMDDRS
- Status last verified
- Oct 2016
- First submitted
- 16 Apr 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy for Major Depressive Disorder Residual Symptoms
- ClinicalTrials.gov ID
- NCT02925325
- Acronym / sponsor ID
- MTMDDRS / INPRF_MUS_THER_MDD
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Music therapy, Residual symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Oct 2016 (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.
Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at the psychiatric clinic, have become a growing problem. Its presence is associated with a high probability of relapse / recurrence and disability, as determined by decreased performance and low quality of life. Their neglect has generated an increase in clinical and socioeconomic costs, alerting the need for research to provide treatment strategies. The application of different types of psychotherapy has been successful in abating SRD. The present study aims to evaluate the clinical changes related to the application of music therapy as a treatment of SRD, through a randomized controlled trial with two treatment arms trial. Music Therapy (MT) is a psychotherapy provided by specialized health professionals, and is defined as the clinical use of musical evidence-based interventions within a therapeutic relationship. MT treatment group will design an application schema of 8 sessions (2 hrs. Each) over a period of two months (one session per week). The control group will receive the Usual Treatment (TU) which corresponds to the usual clinical psychiatric treatment by the physician in the INPRF, with the same duration. The evaluation will be conducted with clinimetric testing at baseline, at the end of the track and after three months of treatment. This study seeks to identify the presence of SRD in a Mexican sample and explore a treatment designed for that purpose, also, show that the MT is a cost-effective implementation can become a new clinical option to extend the possibilities of assistance and deepen the investigation of this problem.
Detailed description
GENERAL PURPOSE:
To evaluate the clinical changes related to the application of music therapy as a treatment for Residual Symptoms of Depression.
SPECIFIC OBJECTIVES:
- Compare the pre and post treatment of residual symptoms by the HAM-D-21, BDI, SCL-90-R and CIDRS levels.
- Compare the change of pre and post treatment obtained by the instruments for quality of life (WHOQOL-BREF), functioning (GAF and PSP) and perceived stress (PSS) values.
METHOD
Design - A randomized controlled trial with two treatment arms: the experimental group Music Therapy (MT); and control group Usual (TU) treatment. MT treatment group will design and will be completed in a period of two months, with an outline of 8 sessions (one per week). The TU corresponds to the usual clinical psychiatric treatment (drug) assigned by the attending physician in the INPRF.
POPULATION - patients attending the outpatient department of the National Institute of Psychiatry "Ramon de la Fuente" between 20 and 45, considered in remission of major depressive disorder (MDD) (DSM-IV) score ≤7 be included points on the Hamilton Depression Scale of (HAM-D-21) and / or ≤9 points in the Beck Depression Inventory (BDI), which have had a positive response to drug treatment and / or remain with pharmacotherapy phase continuation or maintenance, and there report or detection of persistent residual symptoms.
In this research, both participants in the control group and the experimental group, remain drug therapy throughout the study according to the instructions of the attending physician, so the period and type of administration shall be the sole decision of the same. In any case this protocol assessments will be conducted as planned. In the case of any change in drug therapy researchers take note of it for consideration in the final results.
SAMPLE SIZE - According to calculations made, the sample size is 48 patients. With an allocation of 24 patients in each treatment (MT and UT). It is considered to recruit an approximate previous historical studies in SRD sample (Fava et al., 1996; Fava et al., 1998).
To calculate the sample size formula for "comparison of two proportions" (Fernández, 2001), which was used as follows:
Where:
n = subjects required in each of the samples
Za = Z value corresponding to the desired risk
Zb = Z value corresponding to the desired risk
p1 = Value of the proportion in the control group, placebo control or usual treatment.
p2 = Value of the proportion in the group of the new treatment, intervention or technique.
p = average of the two proportions p1 and p2
The following data were considered:
- a confidence level of 95% or safety was established.
- A power of 80%.
- the effectiveness of standard treatment in preventing relapse (Fava et al was set at 32%., 1996; Paykel et al., 1999; Fava et al., 1998; Teasdale et al., 2000; Ma \& Teasdale, 2004).
- was set at 70% of the desired effectiveness for MT in preventing relapse, considering the performance of psychotherapies reported (Fava et al., 1996; Paykel et al., 1999; Fava et al., 1998; Teasdale et al, 2000; Ma. \& Teasdale, 2004).
This accounted for 15% of subjects the possible loss of the sample according to the following formula:
Losses set to n = (1/1-R) shows
n = number of subjects lossless
R = expected loss ratio
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music therapyMusic therapy 8 weekly sessions |
| Usual Treatment | Active comparator | Other: Usual TreatmentIt is the usual medical treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subsequent and file number at the National Institute of Psychiatry "Ramon de la Fuente" patients.
- Male or Female Patients.
- Age 20-45 years.
- Previous diagnosis of MDD according to DSM-IV.
- Presence of residual symptoms, with a score of ≤7 points in the HAM-D-21 and / or ≤9 points in BDI.
Key exclusion criteria (8 listed)
- Patients with psychotic symptoms.
- Patients with suicidal risk.
- Patients with comorbid Axis I.
- Patients with comorbid Axis II as the primary diagnosis.
- Patients with any type of hearing chronic medical illness, neurological or (Eg. Hearing loss, tinnitus, etc.)
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 |
|---|---|---|
| Music therapyMusic therapy (MT) treatment focuses on the use of 2 techniques of intervention: receptive MT and active MT. The work of receptive application is described as the use of prerecorded music or executed by the music therapist with effect on the patient, without the latter's active involvement in the psychotherapeutic process of musical creation. While the active application, both the music therapist and patient are involved in musical creation, for example, the use of voice, body and musical instruments (Muñoz, 2008). Contemplate their psychotherapeutic possibilities in 3 different dimensions of patient: body, emotional and social work, as explained above. Treatment with MT, as in cognitive behavioral therapy, includes breathing exercises, stress-relaxation techniques, psychoeducation, and exercises for the management of irrational thoughts and erratic behavior patterns (Dobson and Dozois, 2010). | Behavioural | Music Therapy |
| Usual TreatmentIt is the usual medical treatment that patients with major depressive disorder in remission but with residual symptom receives at the sponsor institution in a monthly basis. | Other | Usual Treatment |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Clinical Interview for Depression and Related Syndromes
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
5 secondary outcomes
Symptom Checklist 90 Revised (SCL-90-R)
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Beck Depression Inventory
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Personal and social performance scale (PSP)
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Perceived stress scale (PSS)
Time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
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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.
Enrique O Flores Gutierrez, MD PhD study chair
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Jorge Julio González Olvera, MD PHD principal investigator
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and Usual Treatment in people with Major Depressive Disorder, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2016. 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 Mexico. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge J González Olvera, MD PHD (+5215515107370, jjgonz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2016.