A Randomized Clinical Trial for Depressed Mothers at Primary Care Level (DMH)

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Status: Completed

Conditions: Depression

Treatments: Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00519051

1040432

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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345 participants in 1 patient group

control group

Active Comparator group

Description:

patients can receive pharmacotherapy and psychotherapy and specialized treatment

Treatment:

Other: monitorized pharmacotherapy with antidepressants drugs (Fluoxetine)