Self-Identification Program

NCT06183359 | Recruiting

• 1 other identifier: RECHMPL21_0280
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Third Wave Cognitive Behavioral Therapy

Keywords

Depression; psychotherapy

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory (BDI)

  Depressive symptomatology

  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 Outcomes (6)

• 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)

• 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)

• 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)

Study Arms (2)

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

Other: SIP

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).

Other: SIP

Interventions

SIP OTHER

compare the SIP group versus the ACT group

The group Acceptance and Commitment Therapy (ACT); The group Self-Identification Program (SIP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Déborah Ducasse, MD

CONTACT

+33 4 67 33 28 29; d-ducasse@chu-montpellier.fr

Véronique Brand Arpon, IDE

CONTACT

v-arpon@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The group Self-Identification Program (SIP) versus The group Acceptance and Commitment Therapy (ACT)

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: August 27, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)