DepressionNCT01292499
Italian Network for the Improvement of Compliance in Depression
A study testing Psychotherapy, Psychoeducation and Psychoeducation and psychotherapy in people with Depression, run by Ospedale Amedeo di Savoia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Psychotherapy, Psychoeducation and Psychoeducation and psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,264 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASL TO2 Amedeo di Savoia
Torino, Torino, 10149
Carmine Munizza, 00390114395803
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Psychotherapy, Psychoeducation, Psychoeducation and psychotherapy
- Keywords
- psychotherapy, psychoeducation, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
10 sessions (50 min)
PsychoeducationBehavioural
7 sessions + 7 phone calls
Psychoeducation and psychotherapyBehavioural
Psychoeducation + psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation |
| Psychoeducation and psychotherapy | Experimental | Will receive both psychoeducation and psychotherapy sessions. Receives: Behavioral: Psychoeducation and psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startMar 2009
- Primary completionJan 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Amedeo di Savoia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292499
- Sponsor's protocol ID
- RIMAT-De
- Other IDs
- RIMAT-De
- Status last verified
- Dec 2010
- First submitted
- 26 Jan 2011
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Network for the Improvement of Compliance in Depression
- ClinicalTrials.gov ID
- NCT01292499
- Acronym / sponsor ID
- RIMAT-De
- Conditions
- Depression
- Keywords
- psychotherapy, psychoeducation, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,264 participants (estimated)
- Lead sponsor
- Ospedale Amedeo di SavoiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: PsychotherapyWill 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. |
| Psychoeducation | Experimental | Behavioral: PsychoeducationWill 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. |
| Psychoeducation and psychotherapy | Experimental | Behavioral: Psychoeducation and psychotherapyWill receive both psychoeducation and psychotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy10 sessions (50 min) | Behavioural | Psychotherapy |
| Psychoeducation7 sessions + 7 phone calls | Behavioural | Psychoeducation |
| Psychoeducation and psychotherapyPsychoeducation + psychotherapy | Behavioural | Psychoeducation and psychotherapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy, Psychoeducation and Psychoeducation and psychotherapy in people with Depression, run by Ospedale Amedeo di Savoia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmine Munizza (00390114395803, cmunizza@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients showing good compliance, as measured at six months from the beginning of the treatment. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.