Major Depressive DisorderSIPNCT06183359
Self-Identification Program
A study testing SIP in people with Major Depressive Disorder and Third Wave Cognitive Behavioral Therapy, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Third Wave Cognitive Behavioral Therapy
- What is being tested?
- SIP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years, presenting a current major depressive episode (according to DSM 571), as part of unipolar or bipolar depressive disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Véronique Brand Arpon, IDE contact
About this study
Official title: Correct Self-identification Program in the Treatment of Depression: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- SIP
- Keywords
- Depression, psychotherapy
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIPOther
compare the SIP group versus the ACT group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Other: SIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI)
Depressive symptomatology
Measured: 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)
Depressive symptomatology
Measured: 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
visual analog scale 0-10
Measured: 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)
Overall functionning
Measured: 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)
Suicidal behaviors
Measured: 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)
anxious symptomatology
Measured: 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)
Anhedonia
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start27 Aug 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The group Self-Identification Program (SIP) versus The group Acceptance and Commitment Therapy (ACT)
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183359
- Sponsor's protocol ID
- RECHMPL21_0280
- Acronym
- SIP
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2023
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correct Self-identification Program in the Treatment of Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06183359
- Acronym / sponsor ID
- SIP / RECHMPL21_0280
- Keywords
- Depression, psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The group Self-Identification Program (SIP) versus The group Acceptance and Commitment Therapy (ACT)
| Arm | Type | Receives |
|---|---|---|
| The group Self-Identification Program (SIP) | Experimental | Other: SIPThe 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 |
| The group Acceptance and Commitment Therapy (ACT) | Other | Other: SIPThe 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 70 years, presenting a current major depressive episode (according to DSM 571), as part of unipolar or bipolar depressive disorder
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIPcompare the SIP group versus the ACT group | Other | The group Acceptance and Commitment Therapy (ACT), The group Self-Identification Program (SIP) |
Primary outcome
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)
Depressive symptomatology
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Véronique Brand Arpon, IDE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIP in people with Major Depressive Disorder and Third Wave Cognitive Behavioral Therapy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Déborah Ducasse, MD (+33 4 67 33 28 29, d-ducasse@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.