Italian Network for the Improvement of Compliance in Depression

Depression Clinical Trial

Official title:

Italian Network for the Improvement of Compliance in Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01292499
• Other study ID #: RIMAT-De
• Secondary ID: RIMAT-De
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2011
• Last updated: February 8, 2011
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2010
• Source: Ospedale Amedeo di Savoia
• Contact: Carmine Munizza
• Phone: 00390114395803
• Email: cmunizza[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1264
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. New episode of depression, according to the DSM-IV (Codes F32 Major Depressive Disorder, single episode; F33 Major Depressive Disorder, recurrent; F34.1 Dysthymic Disorder; F32.9 Depressive Disorder, not otherwise specified), or new contact with the Mental Health Center for recurrent depression (same Codes) after a six-month period (or longer) without any treatment;

2. Age >= 18 years old;

3. QIDS-SR16 score >=10;

4. Necessity of a pharmacological antidepressant treatment;

5. Written informed content given by the participant before the beginning of the study.

Exclusion Criteria:

1. Comorbidity of schizophrenic disorder, according to the DSM-IV (Codes F06.3 - Organic mood disorder; F20 - Schizophrenia; F29 -Uunspecified Nonorganic Psychosis; F30-F31 - Manic Episode and Bipolar Affective Disorder; F34.0 - Cyclothymia; F10-F19 - Mental and Behavioural Disorders due to Psychoactive Substance Use).

2. Current pregnancy.

3. Probable hospitalization, for whatever reason.

4. Patient seen once and then referred to his/her GP or other specialist physician;

5. Pharmacological treatment already prescribed by a psychiatry or neurology specialist. However, if the patient is not satisfied with the current treatment and/or the psychiatrist involved in the present study considers appropriate to change the treatment, the present exclusion criterion will not be valid any longer.

6. Pharmacological treatment prescribed for more than 15 days by patient's GP. However, if the patient is not satisfied by the treatment and/or the psychiatrist involved in the present study considers appropriate to change the treatment, the present exclusion criterion will not be valid any longer.

7. The patient is currently under psychotherapy.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Psychotherapy
10 sessions (50 min)
• Psychoeducation
7 sessions + 7 phone calls
• Psychoeducation and psychotherapy
Psychoeducation + psychotherapy

Locations

Country	Name	City	State
Italy	ASL TO2 Amedeo di Savoia	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Amedeo di Savoia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients showing good compliance, as measured at six months from the beginning of the treatment.	The effect size is conceptualized as the difference between the proportion of patients in the 4 treatment arms showing good compliance at the end of the study. The effects of the two treatments (psychotherapy and psychoeducation) will be measured separately, via stratified analyses and multivariate regression models, as appropriate.	3 years	Yes