Italian Network for the Improvement of Compliance in Depression
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|ClinicalTrials.gov Identifier: NCT01292499|
Recruitment Status : Unknown
Verified December 2010 by Ospedale Amedeo di Savoia.
Recruitment status was: Recruiting
First Posted : February 9, 2011
Last Update Posted : February 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Psychotherapy Behavioral: Psychoeducation Behavioral: Psychoeducation and psychotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Italian Network for the Improvement of Compliance in Depression|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||July 2012|
No Intervention: Pharmacological treatment
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.
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.
10 sessions (50 min)
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.
7 sessions + 7 phone calls
Experimental: Psychoeducation and psychotherapy
Will receive both psychoeducation and psychotherapy sessions.
Behavioral: Psychoeducation and psychotherapy
Psychoeducation + psychotherapy
- Proportion of patients showing good compliance, as measured at six months from the beginning of the treatment. [ Time Frame: 3 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292499
|Contact: Carmine Munizzaemail@example.com|
|ASL TO2 Amedeo di Savoia||Recruiting|
|Torino, Italy, 10149|
|Contact: Carmine Munizza 00390114395803|