Italian Network for the Improvement of Compliance in Depression

NCT01292499 | Unknown DMC

• 1 other identifier: RIMAT-De
• Study Type: interventional
• Target: 1,264
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

psychotherapy; psychoeducation; depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Pharmacological treatment

NO INTERVENTION

Pharmacological treatment consists of the administration of a single antidepressant drug. The treatment will be administered as currently done by the mental health center, taking into due account patient's age, general health, previous response to antidepressant drugs, comorbidity, and potential side effects of drugs.

Psychotherapy

EXPERIMENTAL

Will receive psychotherapy as well (10 sessions). Psychoterapy will consist of 10 weekly sessions, lasting about 50 minutes each. Psychotherapy will begin after 4-6 weeks from the beginning of the pharmacological treatment, to allow drugs to be effective. The overall list of visits scheduled for the patients is defined during the second psychiatric visit, to allow a reasonable planning of all of the appointments required for that particular patient. Psychotherapists will be free to follow the approach they were trained.

Behavioral: Psychotherapy

Psychoeducation

EXPERIMENTAL

Will receive psychoeducation as well, with phone monitoring and regular follow-ups. Psychoeducation does not simply mean making the patient aware of depression etiology and drugs effect. In fact, patients should receive additional counselling about how to integrate the pharmacological treatment in their daily routine and to solve possible problems, in order to allow them to be actively and constantly involved in the treatment they are going to receive. Patients will receive 7 sessions of psychoeducation and 7 phone calls during the first 5 months. In addition, all of the patients will receive a brochure explaining the most important aspects of their disorder.

Behavioral: Psychoeducation

Psychoeducation and psychotherapy

EXPERIMENTAL

Will receive both psychoeducation and psychotherapy sessions.

Behavioral: Psychoeducation and psychotherapy

Interventions

Psychotherapy BEHAVIORAL

10 sessions (50 min)

Psychotherapy

Psychoeducation BEHAVIORAL

7 sessions + 7 phone calls

Psychoeducation

Psychoeducation and psychotherapy BEHAVIORAL

Psychoeducation + psychotherapy

Psychoeducation and psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age \>= 18 years old;
• QIDS-SR16 score \>=10;
• Necessity of a pharmacological antidepressant treatment;
• Written informed content given by the participant before the beginning of the study.

You may not qualify if:

• 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).
• Current pregnancy.
• Probable hospitalization, for whatever reason.
• Patient seen once and then referred to his/her GP or other specialist physician;
• The patient is currently under psychotherapy.

Sponsors & Collaborators

• Ospedale Amedeo di Savoia: lead

Study Sites (1)

ASL TO2 Amedeo di Savoia

Torino, Torino, 10149, Italy

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Carmine Munizza

CONTACT

00390114395803; cmunizza@tin.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 9, 2011
• Study Start: March 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 9, 2011

Record last verified: 2010-12

Locations

IT (1)