Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398561
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-01
Brief Title:
Peer-led Intervention for Individuals With Major Depression
Sponsor:
University of the Balearic Islands
Organization:
University of the Balearic Islands
Study Overview
Official Title:
Peer-led Intervention for Individuals With Major Depression
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPEERmood
Brief Summary:
Objective To evaluate the efficacy of an adjuvant intervention based on a peer support program in the reduction of depressive symptomatology versus an online intervention in people with major depression in Primary Care Mental Health Units in Mallorca
Design Randomized clinical trial of two branches in a Mental Health Unit of Mallorca where one branch will receive an adjuvant intervention based on a peer support program Active Patient Program and another branch control will receive information and exercises aimed at improving their mental health through the COGITO App designed and validated for this purpose
Scope and study subjects The scope of the study will be the consultations of the Mental Health Unit MHU of Primary Care in Mallorca The study subjects will be patients of these units who meet the criteria for Major Depression The mental health professionals of the MHU will be in charge of recruiting participants who meet the inclusion and exclusion criteria The required sample will be 70 subjects 35 in each branch
Variables The main dependent variable is depressive symptomatology measured through the Beck Depression Inventory BDI-II As secondary variables quality of life and adherence to treatment will be included
Data analysis All analyses will be carried out using the SPSS statistical program An intention-to-treat ITT analysis will be performed The efficacy of the intervention reduction of depressive symptoms BDI-II will be assessed by a general linear model ANOVA at 6 weeks 6 and 12 months adjusted for baseline values
Design Randomized clinical trial of two branches in a Mental Health Unit of Mallorca where one branch will receive an adjuvant intervention based on a peer support program Active Patient Program and another branch control will receive information and exercises aimed at improving their mental health through the COGITO App designed and validated for this purpose
Scope and study subjects The scope of the study will be the consultations of the Mental Health Unit MHU of Primary Care in Mallorca The study subjects will be patients of these units who meet the criteria for Major Depression The mental health professionals of the MHU will be in charge of recruiting participants who meet the inclusion and exclusion criteria The required sample will be 70 subjects 35 in each branch
Variables The main dependent variable is depressive symptomatology measured through the Beck Depression Inventory BDI-II As secondary variables quality of life and adherence to treatment will be included
Data analysis All analyses will be carried out using the SPSS statistical program An intention-to-treat ITT analysis will be performed The efficacy of the intervention reduction of depressive symptoms BDI-II will be assessed by a general linear model ANOVA at 6 weeks 6 and 12 months adjusted for baseline values
Detailed Description:
Material and methods Type of study A two-branch randomized clinical trial will be conducted in which one branch will receive the intervention based on a peer support program Active Patient Program and another branch will receive information and exercises aimed at improving their mental health through a validated App free and in its Spanish version called COGITO which consists of planning exercises based on cognitive-behavioral therapy The App to be used can be found for free by accessing the following link httpsappsapplecomusappcogito-mctid1557322291 for Apple devices httpsplaygooglecomstoreappsdetailsiddeukecogitoapphlen_USpli1 for Android devices
Scope of the study The consultations of the Mental Health Unit MHU will be the site from which the subjects will be recruited The MHU are outpatient and community facilities of the mental health network of the Balearic Islands where people with mental health problems are followed up They consist of a multidisciplinary team of psychiatry psychology mental health nursing and social work professionals In addition to the administrative staff of these units
Definition of study subjects The study subjects will be those persons suffering from Major Depressive Disorder and who are currently under follow-up with one of the professionals of the MHU
Recruitment of participants Recruitment will be done through the medical records of each nurse psychiatrist psychologist or social worker of the USM with current follow-up andor active diagnostic label of Major Depressive Disorder according to ICD or DSM criteria in the Primary Care Information System e-SIAP
An initial interview will be carried out by the research staff in collaboration with the health care staff of the reference MHU to verify compliance with the inclusion criteria for the study
Justification of sample size Accepting an alpha risk of 005 and a beta risk of 02 in a bilateral contrast 35 subjects in the intervention group Active Patient and 35 in the control group are required to detect a difference equal to or greater than 6 units in the Beck Depression Inventory BDI-II The common standard deviation is assumed to be 8 A loss-to-follow-up rate of 20 has been estimated Castro LS et al Psychiatry Res 20132103906-12 Therefore a total of 70 participants will be needed
Primary and secondary variables The primary dependent variable is depressive symptomatology measured by validated BDI-II
The secondary dependent variables are quality of life and adherence to prescribed treatment The main independent variable is the assigned group
Other independent or control variables taken into account in this study are sociodemographic variables age gender marital status diagnostic label year of diagnosis educational level pharmacological treatment psychotherapy treatment USM of reference profession comorbidities current employment situation
Description of the intervention
1 Recruitment and training of active patient trainers
Recruitment will be carried out by MHU professionals through any device of the mental health network or through patients associations andor citizens associations
The trainer patients must meet the following requirements according to the current protocol of the Active Patient Program evaluated through the interview the scales and questionnaires that the program stipulates in its action guide All the information regarding this aspect can be found in detail at the following link httpsdocusalutcomhandle205001300318170
2 Recruitment of participants The recruitment of the study subjects will be carried out by the multidisciplinary team of the MHU psychiatrists psychologists nurses andor social workers of each center Once the sample has been recruited an initial interview will be conducted by the staff of the Active Patient Program team to explain the procedure and assess whether the selected persons accept their participation and meet the inclusion criteria described above
3 Randomization Once the necessary sample has been obtained the participants will be randomized in a 11 ratioPseudo-anonymity of the data is guaranteed since each participant will be identified with a numerical code that will not include any personal data
4 Development of the intervention- Intervention group for patients benefiting from the Active Patient Program training
The training will consist of a workshop of 6 sessions of 2 hours each following the model described in the protocol of the Active Patient Program but adapted to Major Depressive Disorder
The adaptation of this guide will be carried out by a group of professionals from different disciplines experts in mental health Once the guide has been produced it will be sent to people of reference in the field of depressive disorders at a national level so that they can proceed to its revision
The sessions that will guide us in the preparation of the Major Depressive Disorder workshop are detailed in Annex I- Control group through the COGITO AppThe control group will receive a guideline of exercises guided through the COGITO App based on cognitive-behavioral therapy CBT The duration of the use of this App will be the same as the intervention of the Active Patient program 6 weeks having to comply with a pattern of use of the App of 20 minutes daily in order to match the time dedicated to the intervention Thanks to the design of the App its use can be counted through the history of the exercises as well as the appearance of warnings when the use is lowDaily reminders can also be activated to incentivize it
5 Evaluation
A pre-intervention evaluation will be carried out at the beginning of the intervention in both groups another one at the end of the program sessions 6 weeks and two post- evaluations at 6 and 12 months after completion
The degree of depressive symptomatology the quality of life and the degree of adherence to the prescribed treatment will be measured by means of valid instruments
Scope of the study The consultations of the Mental Health Unit MHU will be the site from which the subjects will be recruited The MHU are outpatient and community facilities of the mental health network of the Balearic Islands where people with mental health problems are followed up They consist of a multidisciplinary team of psychiatry psychology mental health nursing and social work professionals In addition to the administrative staff of these units
Definition of study subjects The study subjects will be those persons suffering from Major Depressive Disorder and who are currently under follow-up with one of the professionals of the MHU
Recruitment of participants Recruitment will be done through the medical records of each nurse psychiatrist psychologist or social worker of the USM with current follow-up andor active diagnostic label of Major Depressive Disorder according to ICD or DSM criteria in the Primary Care Information System e-SIAP
An initial interview will be carried out by the research staff in collaboration with the health care staff of the reference MHU to verify compliance with the inclusion criteria for the study
Justification of sample size Accepting an alpha risk of 005 and a beta risk of 02 in a bilateral contrast 35 subjects in the intervention group Active Patient and 35 in the control group are required to detect a difference equal to or greater than 6 units in the Beck Depression Inventory BDI-II The common standard deviation is assumed to be 8 A loss-to-follow-up rate of 20 has been estimated Castro LS et al Psychiatry Res 20132103906-12 Therefore a total of 70 participants will be needed
Primary and secondary variables The primary dependent variable is depressive symptomatology measured by validated BDI-II
The secondary dependent variables are quality of life and adherence to prescribed treatment The main independent variable is the assigned group
Other independent or control variables taken into account in this study are sociodemographic variables age gender marital status diagnostic label year of diagnosis educational level pharmacological treatment psychotherapy treatment USM of reference profession comorbidities current employment situation
Description of the intervention
1 Recruitment and training of active patient trainers
Recruitment will be carried out by MHU professionals through any device of the mental health network or through patients associations andor citizens associations
The trainer patients must meet the following requirements according to the current protocol of the Active Patient Program evaluated through the interview the scales and questionnaires that the program stipulates in its action guide All the information regarding this aspect can be found in detail at the following link httpsdocusalutcomhandle205001300318170
2 Recruitment of participants The recruitment of the study subjects will be carried out by the multidisciplinary team of the MHU psychiatrists psychologists nurses andor social workers of each center Once the sample has been recruited an initial interview will be conducted by the staff of the Active Patient Program team to explain the procedure and assess whether the selected persons accept their participation and meet the inclusion criteria described above
3 Randomization Once the necessary sample has been obtained the participants will be randomized in a 11 ratioPseudo-anonymity of the data is guaranteed since each participant will be identified with a numerical code that will not include any personal data
4 Development of the intervention- Intervention group for patients benefiting from the Active Patient Program training
The training will consist of a workshop of 6 sessions of 2 hours each following the model described in the protocol of the Active Patient Program but adapted to Major Depressive Disorder
The adaptation of this guide will be carried out by a group of professionals from different disciplines experts in mental health Once the guide has been produced it will be sent to people of reference in the field of depressive disorders at a national level so that they can proceed to its revision
The sessions that will guide us in the preparation of the Major Depressive Disorder workshop are detailed in Annex I- Control group through the COGITO AppThe control group will receive a guideline of exercises guided through the COGITO App based on cognitive-behavioral therapy CBT The duration of the use of this App will be the same as the intervention of the Active Patient program 6 weeks having to comply with a pattern of use of the App of 20 minutes daily in order to match the time dedicated to the intervention Thanks to the design of the App its use can be counted through the history of the exercises as well as the appearance of warnings when the use is lowDaily reminders can also be activated to incentivize it
5 Evaluation
A pre-intervention evaluation will be carried out at the beginning of the intervention in both groups another one at the end of the program sessions 6 weeks and two post- evaluations at 6 and 12 months after completion
The degree of depressive symptomatology the quality of life and the degree of adherence to the prescribed treatment will be measured by means of valid instruments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None