Music Therapy for Major Depressive Disorder Residual Symptoms

NCT02925325 | Unknown

• 1 other identifier: INPRF_MUS_THER_MDD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Music therapy; Residual symptoms

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale

  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

  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)

  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

  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)

  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)

  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)

  3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up

Other Outcomes (1)

• Global of Functioning Assessment Scale (GAF)

  3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up

Study Arms (2)

Music Therapy

EXPERIMENTAL

Music therapy 8 weekly sessions

Behavioral: Music therapy

Usual Treatment

ACTIVE COMPARATOR

It is the usual medical treatment.

Other: Usual Treatment

Interventions

Music therapy BEHAVIORAL

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).

Music Therapy

Usual Treatment OTHER

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.

Usual Treatment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead

Study Sites (1)

Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz

Mexico City, Mexico City, 14370, Mexico

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Enrique O Flores Gutierrez, MD PhD

  Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

  STUDY CHAIR

• Jorge Julio González Olvera, MD PHD

  Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge J González Olvera, MD PHD

CONTACT

+5215515107370; jjgonz@gmail.com

Enrique O Flores Gutierrez, MD PhD

CONTACT

+525541605381; florese@imp.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: October 5, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

ME (1)