Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06183359 |
| Other study ID # |
RECHMPL21_0280 / UF5036 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
February 1, 2027 |
Study information
| Verified date |
January 2024 |
| Source |
University Hospital, Montpellier |
| Contact |
Déborah Ducasse, MD |
| Phone |
+33 4 67 33 28 29 |
| Email |
d-ducasse[@]chu-montpellier.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
patients/week), coordinated by Dr Ducasse (internationally recognized in the field).
Outcomes/prospects: 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.
