search
Back to results

Italian Network for the Improvement of Compliance in Depression

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Psychotherapy
Psychoeducation
Psychoeducation and psychotherapy
Sponsored by
Ospedale Amedeo di Savoia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring psychotherapy, psychoeducation, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ASL TO2 Amedeo di SavoiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Pharmacological treatment

Psychotherapy

Psychoeducation

Psychoeducation and psychotherapy

Arm Description

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.

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.

Will receive both psychoeducation and psychotherapy sessions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2011
Last Updated
February 8, 2011
Sponsor
Ospedale Amedeo di Savoia
search

1. Study Identification

Unique Protocol Identification Number
NCT01292499
Brief Title
Italian Network for the Improvement of Compliance in Depression
Official Title
Italian Network for the Improvement of Compliance in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ospedale Amedeo di Savoia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
psychotherapy, psychoeducation, depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacological treatment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation and psychotherapy
Arm Type
Experimental
Arm Description
Will receive both psychoeducation and psychotherapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
10 sessions (50 min)
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
7 sessions + 7 phone calls
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation and psychotherapy
Intervention Description
Psychoeducation + psychotherapy
Primary Outcome Measure Information:
Title
Proportion of patients showing good compliance, as measured at six months from the beginning of the treatment.
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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. 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. The patient is currently under psychotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmine Munizza
Phone
00390114395803
Email
cmunizza@tin.it
Facility Information:
Facility Name
ASL TO2 Amedeo di Savoia
City
Torino
ZIP/Postal Code
10149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmine Munizza
Phone
00390114395803

12. IPD Sharing Statement

Learn more about this trial

Italian Network for the Improvement of Compliance in Depression

We'll reach out to this number within 24 hrs