Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-13
Brief Title:
Self-Identification Program
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Correct Self-identification Program in the Treatment of Depression a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
SIP
Brief Summary:
Conduct a pilot single-center randomized controlled 2-arm study aimed to evaluate the impact of an in-depth 3rd wave CBT program targeting correct self-identification 3rd level of 3rd wave CBT compared to a control group receiving an acceptance and commitment therapy ACT 1st level of 3rd wave CBT a well-known psychotherapy Main judgment criteria Therapeutic response reduction 50 between pre and immediate post-treatment and rate of relapse at 6 months post-therapy Secondary objectives Evaluate psychological processes involved in the reduction of moral pain diligence ruminations suicidal ideas self-concept and alterations in functioning mental and social psychological skills
Detailed Description:
According to the World Health Organization WHO depression is one of the health problems most prevalent mental health issues of the 21st century Currently available treatments are insufficient to treat effectively combat depression prevent relapse and provide a care offer accessible to all people requiring Self-identification is at the heart of the dimensional understanding of this disorder including moral pain inherent is associated with excess suicide mortality From altered relationships to negative affectivity and affectivity positive are central psychological processes that maintain depression and promote relapse Cognitive and behavioral psychotherapies CBT are the reference in addition to medications The paramedical team nurses and psychologists of the Therapies Center CHU Montpellier has created a program targeting correct Self-Identification SIP 3rd level of 3rd wave CBT allowing the reestablishment of functional relationships This notable innovation was welcomed by the World Health Organisation which requested its presentation during the meeting of the United Nations in Geneva in June 2021 international exhibition on resilience
Main objectives Conduct a pilot single-center randomized controlled 2-arm study aimed to evaluate the impact of an in-depth 3rd wave CBT program targeting correct self-identification 3rd level of 3rd wave CBT compared to a control group receiving an acceptance and commitment therapy ACT 1st level of 3rd wave CBT a well-known psychotherapy Main judgment criteria Therapeutic response reduction 50 between pre and immediate post-treatment and rate of relapse at 6 months post-therapy Secondary objectives Evaluate psychological processes involved in the reduction of moral pain diligence ruminations suicidal ideas self-concept and alterations in functioning mental and social psychological skills
Statistical analysis A descriptive analysis of the initial characteristics of the patients will be carried out in each of the groups to check initial comparability The analyzes of the judgment criteria will be carried out with an intention-to-treat analysis
Feasibility Paramedical team nurses and psychologists specialized in 3rd wave CBT 200 patientsweek coordinated by Dr Ducasse internationally recognized in the field
Outcomesprospects This program should 1 reduce the frequency and intensity of mental illnesses symptoms and the associated mental pain 2 prevent the negative consequences of mental illnesses poor quality of life isolation self-damaging behavior 3 reduce the mental illness stigma
3rd wave CBTs constitute programs that can be delivered in group sessions by both nurses and psychologists with appropriate training This ensures its potential for wide distribution where France faces a shortage of psychotherapeutic offerings
Such a program will undeniably constitute an important contribution on the dimensional understanding of mental illnesses and the implementation of innovative transnosographic psychotherapeutic care
Main objectives Conduct a pilot single-center randomized controlled 2-arm study aimed to evaluate the impact of an in-depth 3rd wave CBT program targeting correct self-identification 3rd level of 3rd wave CBT compared to a control group receiving an acceptance and commitment therapy ACT 1st level of 3rd wave CBT a well-known psychotherapy Main judgment criteria Therapeutic response reduction 50 between pre and immediate post-treatment and rate of relapse at 6 months post-therapy Secondary objectives Evaluate psychological processes involved in the reduction of moral pain diligence ruminations suicidal ideas self-concept and alterations in functioning mental and social psychological skills
Statistical analysis A descriptive analysis of the initial characteristics of the patients will be carried out in each of the groups to check initial comparability The analyzes of the judgment criteria will be carried out with an intention-to-treat analysis
Feasibility Paramedical team nurses and psychologists specialized in 3rd wave CBT 200 patientsweek coordinated by Dr Ducasse internationally recognized in the field
Outcomesprospects This program should 1 reduce the frequency and intensity of mental illnesses symptoms and the associated mental pain 2 prevent the negative consequences of mental illnesses poor quality of life isolation self-damaging behavior 3 reduce the mental illness stigma
3rd wave CBTs constitute programs that can be delivered in group sessions by both nurses and psychologists with appropriate training This ensures its potential for wide distribution where France faces a shortage of psychotherapeutic offerings
Such a program will undeniably constitute an important contribution on the dimensional understanding of mental illnesses and the implementation of innovative transnosographic psychotherapeutic care
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