Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Jorge J González Olvera, MD PHD
CONTACT
Enrique O Flores Gutierrez, MD PhD
CONTACT
Lead
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
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 = (1/1-R) shows n = number of subjects lossless R = expected loss ratio
Age
20–45
Sex
ALL
Healthy volunteers
Not accepted
