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Music Therapy for Major Depressive Disorder Residual Symptoms (MTMDDRS)

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ClinicalTrials.gov Identifier: NCT02925325
Recruitment Status : Unknown
Verified October 2016 by Jorge J. González Olvera, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente.
Recruitment status was:  Recruiting
First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge J. González Olvera, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Music therapy Other: Usual Treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Music Therapy for Major Depressive Disorder Residual Symptoms
Study Start Date : October 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Music Therapy
Music therapy 8 weekly sessions
Behavioral: Music therapy
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).

Active Comparator: Usual Treatment
It is the usual medical treatment.
Other: Usual Treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Other Outcome Measures:
  1. Global of Functioning Assessment Scale (GAF) [ 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 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925325


Contacts
Contact: Jorge J González Olvera, MD PHD +5215515107370 jjgonz@gmail.com
Contact: Enrique O Flores Gutierrez, MD PhD +525541605381 florese@imp.edu.mx

Locations
Mexico
Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz Recruiting
Mexico City, DF, Mexico, 14370
Contact: Jorge J Gonzalez Olvera, MD PhD    +5215515107370    jjgonz@gmail.com   
Contact: Enrique O Flores Gutierrez, MD PhD    +525541605381    florese@imp.edu.mx   
Sub-Investigator: Victor A Teran Camarena, BA         
Sponsors and Collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Investigators
Study Chair: Enrique O Flores Gutierrez, MD PhD Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Principal Investigator: Jorge Julio González Olvera, MD PHD Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Responsible Party: Jorge J. González Olvera, Dr., Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier: NCT02925325     History of Changes
Other Study ID Numbers: INPRF_MUS_THER_MDD
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Jorge J. González Olvera, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente:
Major depressive disorder
Music therapy
Residual symptoms

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms