Self-Identification Program to restore healthier self-identity in adults with depression
Correct Self-identification Program in the Treatment of Depression: a Randomized Controlled Trial
This program tests whether an in-depth third-wave CBT approach focused on correcting self-identification works better than ACT to reduce depressive symptoms and lower relapse risk in adults with a current major depressive episode.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06183359 on ClinicalTrials.gov |
What this trial studies
This is a pilot, single-center, randomized two-arm interventional trial comparing a novel Self-Identification Program (SIP; a third-level third-wave CBT intervention) to an active control using Acceptance and Commitment Therapy (ACT). Adults aged 18–70 with a current major depressive episode (unipolar or bipolar) are randomized to receive SIP or ACT, with outcomes measured immediately after treatment and at six months. The primary endpoints are therapeutic response (≥50% symptom reduction from baseline to immediate post-treatment) and relapse rate at six months; secondary measures capture changes in moral pain, rumination, suicidal thoughts, self-concept, functioning, diligence, and psychological skills. The protocol excludes patients with psychotic disorders, active intent to carry out suicide, inability to consent, pregnancy or breastfeeding, and those not covered by French social security.
Who should consider this trial
Good fit: Adults 18–70 years old with a current major depressive episode (part of unipolar or bipolar depression), able to give informed consent and attend in-person sessions at CHU Montpellier, are the intended participants.
Not a fit: Patients with psychotic disorders, active suicidal intent, inability to consent, those not covered by French social security, pregnant or breastfeeding individuals, or those under legal guardianship are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could produce larger short-term symptom reductions and lower relapse rates by restoring healthier self-identification and improving related psychological processes.
How similar studies have performed: Related third-wave CBT approaches such as ACT and mindfulness-based therapies have shown benefit for depression, but the specific SIP targeting 'correct self-identification' is a novel, minimally tested intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- CHU Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Déborah Ducasse, MD
- Email: d-ducasse@chu-montpellier.fr
- Phone: +33 4 67 33 28 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.