Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02925325
Status:
UNKNOWN
Last Update Posted:
2016-10-05
First Post:
2015-04-16
Brief Title:
Music Therapy for Major Depressive Disorder Residual Symptoms
Sponsor:
Instituto Nacional de Psiquiatría Dr Ramón de la Fuente
Organization:
Instituto Nacional de Psiquiatría Dr Ramón de la Fuente
Study Overview
Official Title:
Music Therapy for Major Depressive Disorder Residual Symptoms
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTMDDRS
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
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
1 Compare the pre and post treatment of residual symptoms by the HAM-D-21 BDI SCL-90-R and CIDRS levels
2 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 11-R shows
n number of subjects lossless
R expected loss ratio
To evaluate the clinical changes related to the application of music therapy as a treatment for Residual Symptoms of Depression
SPECIFIC OBJECTIVES
1 Compare the pre and post treatment of residual symptoms by the HAM-D-21 BDI SCL-90-R and CIDRS levels
2 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 11-R shows
n number of subjects lossless
R expected loss ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None