Italian Network for the Improvement of Compliance in Depression

Depression Clinical Trial

Official title: Italian Network for the Improvement of Compliance in Depression

Status Recruiting

Clinical Trial Summary

The RIMAT‐De study (Rete Italiana per il Miglioramento dell'Adesione al Trattamento nella Depressione) is a multicentric Randomized Controlled Clinical Trial aiming at identifying the best strategies available to reduce the poor compliance of patients with antidepressant drugs. Patients' compliance will be measured within six months of pharmacological treatment, comparing the specific contributions of brief psychotherapy and psychoeducational interventions: the psychoeducational intervention will encompass the monitoring of drugs' side effects and patients' satisfaction. In the rest of the document, for the sake of brevity the two treatments previously described will be indicated as "psychotherapy" and "psychoeducation". These treatments will be compared with the treatment usually carried on by the mental health centers involved (i.e. treatment as usual, TAU). The factorial design of the study will take into consideration the combination of the two treatments (i.e. psychotherapy and psychoeducation) as well.

Clinical Trial Description

Another important aim of the study is the investigation of whether the clinical improvement depends on the efficacy of the psychological treatments proposed per se, or whether they just contribute to increase the compliance with the pharmacological treatment, maintaining the patients on treatment longer and allowing the drugs to reach long‐lasting effects. While recognizing the general therapeutic efficacy of psychotherapy in the treatment of depressive disorders, nevertheless the present study aims at verifying whether an equal therapeutic effect may be reached via a better compliance with the pharmacological treatment, fostered for example by the psychoeducational intervention. The rationale lays on the ease of transferability of psychoeducational interventions to the general clinical practice, that usually suffers from lack of resources in implementing structured psychotherapy interventions. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT01292499
• Study type: Interventional
• Source: Ospedale Amedeo di Savoia
• Contact: Carmine Munizza
• Phone: 00390114395803
• Email: cmunizza@tin.it
• Status: Recruiting
• Phase: N/A
• Start date: March 2009
• Completion date: July 2012