Clinical trial NCT00519051: A Randomized Clinical Trial for Depressed Mothers at Primary Care Level
Official title: Efectividad de la Farmacoterapia Monitorizada en Pacientes Deprimidas de la atención Primaria de Salud y su repercusión Sobre la Salud Mental de Sus Hijos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
primary care
pharmacotherapy
Lead sponsor: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Sponsor class: OTHER_GOV
First posted: 2007-08-21
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial was carried out at primary care level in Santiago, Chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.

Hypothesis: pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers.

Detailed description: Aim:to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.

Material and methods: A RCT wasw carried out at primary care clinics in Santiago.Sample:three hundred and forty five depressed women . One children of each mother was randomly selected. Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease, for 6 months. Women were blindly evaluated at 3, 6 and 12 months with the Hamilton depression rating score (HDRS) and the SF-36 to assess depressive symptoms and quality of life, respectively; the Dyadic Adjustment Scale to assess marital adjustment.

Child psychopathology was assessed with the Child Behavior Checklist (CBCL), the Brief Psychiatric Rating Scale for Children (BPRS-C), Screen for Child Anxiety Related Emotional Disorders(SCARED)and the Children's Depression Inventory.

Eligibility criteria: Inclusion Criteria:

* depressed mothers with al least one child aged 6-16

Exclusion Criteria:

* currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.

Primary outcomes:
measure: depressive symptoms measured with the HDRS
timeFrame: at 3,6 and 12 months after randomization
Secondary outcomes:
measure: quality of life measured with the SF-36
timeFrame: at 3,6 and 12 months after randomization
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CORESAM Conchali
state: Region Metropolitana
Study officials:
affiliation: University of Chile
name: rosemarie fritsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fritsch R, Araya R, Solis J, Montt E, Pilowsky D, Rojas G. [A randomized trial of pharmacotherapy with telephone monitoring to improve treatment of depression in primary care in Santiago, Chile]. Rev Med Chil. 2007 May;135(5):587-95. Epub 2007 Jul 9. Spanish.