Menu
Recruiting NCT06183359

Self-Identification Program

No phase Interventional Major Depressive Disorder Third Wave Cognitive Behavioral Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIP.
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Third Wave Cognitive Behavioral Therapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Correct Self-identification Program in the Treatment of Depression: a Randomized Controlled Trial

Overview

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 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.

Interventions

  • Other SIP
    compare the SIP group versus the ACT group

Primary outcome measures

  • Beck Depression Inventory (BDI) [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]
Secondary outcome measures (6)
  • montgomery asberg depression scale (MADRS) [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]
  • Variation in moral pain [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]
  • Functioning Assessment Short Test (FAST) [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]
  • anxious symptomatology (STAI-State) [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]
  • Snaith-Hamilton Pleasure Scale (SHAPS) [Time frame: Between pre- and immediate post-therapy, 3 months post-intervention and 6 months after the intervention (in the intervention group compared to the control group)]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 to 70 years, presenting a current major depressive episode (according to DSM 571), as part of unipolar or bipolar depressive disorder

Exclusion criteria

  • Patients with a psychotic disorder
  • Patients with active thoughts of suicide with intention to carry out the act (C-SSRS "ideation suicidal" in the last week ≥ 4)
  • Inability to receive informed information about the study
  • Exclusion period determined by a previous study
  • Adult protected by law or patient under guardianship or curatorship
  • Not be affiliated to a French social security scheme or beneficiary of such a scheme
  • Not being able to give informed written consent
  • Pregnant or breastfeeding women
  • Patients under judicial protection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Montpellier — Montpellier

Identifiers

NCT: NCT06183359 · RECHMPL21_0280

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗