跳至主要内容
临床试验/NCT06183359
NCT06183359招募中不适用

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

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
86
试验地点
1
主要终点
Beck Depression Inventory (BDI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

The group Self-Identification Program (SIP)

Experimental

The Self-Identification Program (SIP) is a third level of third wave CBT.

It targets a correct self-identification through the of the following skills :

  • understand the nature and functioning of one's own mind (=conscious power, what allows the appearance of experiences);
  • learn to identify with the characteristics of the mind : to provide soothing (session 1), reassuring power (session 2), benevolent power (session 3), discerning power (session 4), prioritizing power (session 5), acting power (session 6), creative power (session 7), liberating power (session 8)
  • live better with your emotions and moods (and their dysregulation);
  • develop more respectful communication for oneself and others

干预措施: SIP (Other)

The group Acceptance and Commitment Therapy (ACT)

Other

The Acceptance and Commitment Therapy (ACT) is a first level of third wave CBT.

It targets the development of the following skills, consistent with the content of programs validated in the domain :

  • decision-making tool (matrix (session 1));
  • flexibility skills: defusion (session 2), Self as context (session 4), acceptance (session 4), contact with the present moment (session 5), values (session 6), valued actions (session 7), toolkit skills (session 8).

干预措施: SIP (Other)

结局指标

主要结局

Beck Depression Inventory (BDI)

时间窗: 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)

Depressive symptomatology

次要结局

  • montgomery asberg depression scale (MADRS)(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)(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(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)(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)(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)(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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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