Borderline Personality DisorderICSNCT07199166
Effectiveness of Autobiographical Rewriting Workshops on the Socio-Professional Functioning of Patients With Borderline Personality Disorder Undergoing Third-Wave Cognitive and Behavioral Therapy: A Randomized Controlled Trial
A study testing Autobiographical Rewriting Workshops and Non-specific writing workshops in people with Borderline Personality Disorder and Borderline Personality Disorder (BPD), run by University Hospital, Montpellier.
Trial summary
This study evaluates the effectiveness of autobiographical rewriting workshops combined with third-wave Cognitive Behavioral Therapy (CBT) in improving social and professional functioning in individuals with Borderline Personality Disorder (BPD). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Borderline Personality Disorder, Borderline Personality Disorder (BPD)
- What is being tested?
- Autobiographical Rewriting Workshops and Non-specific writing workshops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with borderline personality disorder (assessed by SCID-2),
- Subjects aged between 18 and 45 years (inclusive).
Who cannot join
- Psychotic disorder (assessed by SCID),
- Subjects deprived of their liberty (by judicial or administrative decision, or involuntary hospitalization),
- Subjects under legal protection (guardianship, curatorship, or judicial protection),
- Subjects not affiliated with a social security,
- Pregnant or breastfeeding women,
- Inability to understand the nature, purpose, and methodology of the study,
- Inability to understand, speak, or write French,
- Failure to provide informed oral consent to participate in the study.
About this study
This study evaluates the effectiveness of autobiographical rewriting workshops combined with third-wave Cognitive Behavioral Therapy (CBT) in improving social and professional functioning in individuals with Borderline Personality Disorder (BPD). BPD affects approximately 2 to 6% of the general population and is frequently associated with suicidal behaviors, unstable relationships, and low self-esteem. This disorder is often linked to early traumatic experiences that impact autobiographical memory and self-perception. While Dialectical Behavioral Therapy (DBT) is a standard treatment for BPD, it does not fully address all the needs of patients.
The aim of this study is to determine whether autobiographical rewriting, which allows individuals to restructure and reinterpret their memories in a more resilient way, can improve autobiographical memory, self-esteem, and reduce emotional symptoms. Participants will be randomized into two groups: one group will undergo autobiographical rewriting workshops in addition to third-wave CBT sessions, while the other group will participate in non-specific writing sessions also in addition to third-wave CBT sessions. The study will compare the two groups to evaluate the effectiveness of autobiographical rewriting workshops in enhancing social and professional well-being.
Expected outcomes include improvements in interpersonal relationships, greater professional stability, and a reduction in emotional symptoms assessed immediately post-intervention, then 3 months and 6 months after. This study may offer a complementary therapeutic approach to existing treatments, helping patients manage their symptoms more effectively and improve their quality of life.
- Being tested
- Autobiographical Rewriting Workshops, Non-specific writing workshops
- Keywords
- borderline personality disorder, autobiographical rewriting, third wave CBT
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autobiographical Rewriting WorkshopsBehavioural
10 two-hour autobiographical rewriting workshop sessions, held weekly. This program encourages participants to explore their own history in a way that fosters narrative resilience, highlighting their ability to overcome challenges, transform failures into learning opportunities, express themselves creatively, reexamine their memories, and rebuild a more positive sense of identity that better aligns with the needs of accurate self-recognition of their potential. This program is particularly inspired by the concepts of resilience (Boris Cyrulnik), identification (Karine Gros), the Hero's Journey (Joseph Campbell), narrative therapy (David Denborough), and works on various types of story structures (Blake Snyder).
Non-specific writing workshopsBehavioural
10 sessions of 2 hours of non-specific writing, held weekly. To increase the active role of the participants, they will be encouraged to write on the theme of the session during the time between sessions. The writing themes are non-specific, unlike the intervention group, and include topics such as poetry, historical events, nature reports, imaginary interviews, children's stories, etc.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | Sessions of maintenance in third-wave CBT as part of the usual treatment plan (10 weekly sessions of 45 minutes over 10 weeks) + Autobiographical Rewriting Workshops (10 autobiographical rewriting sessions over 10 weeks, one session per week) Receives: Behavioral: Autobiographical Rewriting Workshops |
| CONTROL GROUP | Placebo comparator | Third-wave CBT maintenance sessions as part of the usual treatment plan (10 weekly sessions of 45 minutes over 10 weeks) + Non-specific Writing Workshops (10 autobiographical non-specific writing sessions over 10 weeks, one session per week) Receives: Behavioral: Non-specific writing workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Social Functioning
The change in the score on the Social Functioning Questionnaire (SFQ) will be assessed between pre-intervention and post-intervention immediately, and compared between the two groups. The SFQ measures social functioning over the past two weeks, with 16 items divided into 8 domains: professional activities, daily life tasks, leisure, family and couple relationships, extrafamily relationships, financial and administrative management, general health, and community life and information. For each domain, participants assess the frequency and satisfaction of their activities
Measured: immediate post-intervention
Secondary outcomes (26)
Autobiographical Memory
The Thinking About Life Experiences (TALE) scale will be used to assess the frequency of autobiographical memory recall and its functions. Autobiographical memory is defined as a collection of information and memories unique to an individual, accumulated from early life, and enabling the construction of a sense of identity and continuity. The TALE consists of 15 items, divided into 3 dimensions (5 items per dimension), which measure different functions of autobiographical memories: Self-related function, social function, and directive function
Measured: immediate post-intervention
Autobiographical Memory
The Thinking About Life Experiences (TALE) scale will be used to assess the frequency of autobiographical memory recall and its functions. Autobiographical memory is defined as a collection of information and memories unique to an individual, accumulated from early life, and enabling the construction of a sense of identity and continuity. The TALE consists of 15 items, divided into 3 dimensions (5 items per dimension), which measure different functions of autobiographical memories: Self-related function, social function, and directive function
Measured: 3 months post-intervention
Improvement in Social Functioning
The change in the score on the Social Functioning Questionnaire (SFQ) will be assessed between pre-intervention and post-intervention immediately, and compared between the two groups. The SFQ measures social functioning over the past two weeks, with 16 items divided into 8 domains: professional activities, daily life tasks, leisure, family and couple relationships, extrafamily relationships, financial and administrative management, general health, and community life and information. For each domain, participants assess the frequency and satisfaction of their activities
Measured: 3 months post-intervention
Improvement in Social Functioning
The change in the score on the Social Functioning Questionnaire (SFQ) will be assessed between pre-intervention and post-intervention immediately, and compared between the two groups. The SFQ measures social functioning over the past two weeks, with 16 items divided into 8 domains: professional activities, daily life tasks, leisure, family and couple relationships, extrafamily relationships, financial and administrative management, general health, and community life and information. For each domain, participants assess the frequency and satisfaction of their activities
Measured: 6 months post-intervention
Autobiographical Memory
The Thinking About Life Experiences (TALE) scale will be used to assess the frequency of autobiographical memory recall and its functions. Autobiographical memory is defined as a collection of information and memories unique to an individual, accumulated from early life, and enabling the construction of a sense of identity and continuity. The TALE consists of 15 items, divided into 3 dimensions (5 items per dimension), which measure different functions of autobiographical memories: Self-related function, social function, and directive function
Measured: 6 months post-intervention
Borderline Symptom Severity
The Borderline Symptom List (BSL23) will be used to evaluate the intensity of borderline symptoms. The scale includes 23 items designed to assess the severity of symptoms associated with borderline personality disorder. A higher score indicates more severe symptoms.
Measured: immediate post-intervention
Borderline Symptom Severity
The Borderline Symptom List (BSL23) will be used to evaluate the intensity of borderline symptoms. The scale includes 23 items designed to assess the severity of symptoms associated with borderline personality disorder. A higher score indicates more severe symptoms.
Measured: 3 months post-intervention
Borderline Symptom Severity
The Borderline Symptom List (BSL23) will be used to evaluate the intensity of borderline symptoms. The scale includes 23 items designed to assess the severity of symptoms associated with borderline personality disorder. A higher score indicates more severe symptoms.
Measured: 6 months post-intervention
Self-Concept Clarity
The Self-Concept Clarity Scale (SCC) will be used to measure the degree to which beliefs about the self are perceived as clearly defined, consistent, and stable over time. The scale includes 12 items and is unidimensional. A higher score indicates greater clarity and stability of self-beliefs, while a lower score reflects more confusion and instability in self-concept
Measured: immediate post-intervention
Self-Concept Clarity
The Self-Concept Clarity Scale (SCC) will be used to measure the degree to which beliefs about the self are perceived as clearly defined, consistent, and stable over time. The scale includes 12 items and is unidimensional. A higher score indicates greater clarity and stability of self-beliefs, while a lower score reflects more confusion and instability in self-concept
Measured: 3 months post-intervention
Self-Concept Clarity
The Self-Concept Clarity Scale (SCC) will be used to measure the degree to which beliefs about the self are perceived as clearly defined, consistent, and stable over time. The scale includes 12 items and is unidimensional. A higher score indicates greater clarity and stability of self-beliefs, while a lower score reflects more confusion and instability in self-concept
Measured: 6 months post-intervention
Self-Defining Future Projections
The Self-Defining Future Projections Scale (SDFP) will assess participants' future projections related to their self-concept. Participants are asked to write down three future projections defining the self and rate each projection on three dimensions: emotional valence (positive or negative), emotional intensity, and personal significance. The projections must meet six specific criteria (e.g., occurring within the next year, being plausible, and personally important).
Measured: immediate post-intervention
Self-Defining Future Projections
The Self-Defining Future Projections Scale (SDFP) will assess participants' future projections related to their self-concept. Participants are asked to write down three future projections defining the self and rate each projection on three dimensions: emotional valence (positive or negative), emotional intensity, and personal significance. The projections must meet six specific criteria (e.g., occurring within the next year, being plausible, and personally important).
Measured: 3 months post-intervention
Self-Defining Future Projections
The Self-Defining Future Projections Scale (SDFP) will assess participants' future projections related to their self-concept. Participants are asked to write down three future projections defining the self and rate each projection on three dimensions: emotional valence (positive or negative), emotional intensity, and personal significance. The projections must meet six specific criteria (e.g., occurring within the next year, being plausible, and personally important).
Measured: 6 months post-intervention
Self-Esteem
The Rosenberg Self-Esteem Scale (RSES) will be used to measure self-esteem or self-confidence. This 10-item scale is unidimensional and assesses the overall positive or negative evaluation of the self. A higher score indicates higher self-esteem, while a lower score reflects lower self-esteem
Measured: immediate post-intervention
Self-Esteem
The Rosenberg Self-Esteem Scale (RSES) will be used to measure self-esteem or self-confidence. This 10-item scale is unidimensional and assesses the overall positive or negative evaluation of the self. A higher score indicates higher self-esteem, while a lower score reflects lower self-esteem
Measured: 3 months post-intervention
Self-Esteem
The Rosenberg Self-Esteem Scale (RSES) will be used to measure self-esteem or self-confidence. This 10-item scale is unidimensional and assesses the overall positive or negative evaluation of the self. A higher score indicates higher self-esteem, while a lower score reflects lower self-esteem
Measured: 6 months post-intervention
Reflective Emotions (Shame)
The TOSCA-3 (Test of Self-Conscious Affect) will assess the propensity to experience shame. This self-report scale consists of 16 relational scenarios, each followed by different potential emotional reactions. Participants are asked to imagine themselves in the situation described in each scenario and rate how much each proposed reaction aligns with their own emotional response on a Visual Analogue Scale (VAS) from 1 ("Not at all in agreement with my reaction") to 5 ("Completely in agreement with my reaction").
Measured: immediate post-intervention
Reflective Emotions (Shame)
The TOSCA-3 (Test of Self-Conscious Affect) will assess the propensity to experience shame. This self-report scale consists of 16 relational scenarios, each followed by different potential emotional reactions. Participants are asked to imagine themselves in the situation described in each scenario and rate how much each proposed reaction aligns with their own emotional response on a Visual Analogue Scale (VAS) from 1 ("Not at all in agreement with my reaction") to 5 ("Completely in agreement with my reaction").
Measured: 3 months post-intervention
Reflective Emotions (Shame)
The TOSCA-3 (Test of Self-Conscious Affect) will assess the propensity to experience shame. This self-report scale consists of 16 relational scenarios, each followed by different potential emotional reactions. Participants are asked to imagine themselves in the situation described in each scenario and rate how much each proposed reaction aligns with their own emotional response on a Visual Analogue Scale (VAS) from 1 ("Not at all in agreement with my reaction") to 5 ("Completely in agreement with my reaction").
Measured: 6 months post-intervention
Sense of Coherence
The Sense of Coherence Scale (SOC-8) is an 8-item scale used to evaluate identity disturbance. It measures how well individuals perceive their life experiences as comprehensible, manageable, and meaningful, reflecting their sense of coherence and overall well-being. Higher score indicates greater coherence.
Measured: immediate post-intervention
Sense of Coherence
The Sense of Coherence Scale (SOC-8) is an 8-item scale used to evaluate identity disturbance. It measures how well individuals perceive their life experiences as comprehensible, manageable, and meaningful, reflecting their sense of coherence and overall well-being. Higher score indicates greater coherence.
Measured: 3 months post-intervention
Sense of Coherence
The Sense of Coherence Scale (SOC-8) is an 8-item scale used to evaluate identity disturbance. It measures how well individuals perceive their life experiences as comprehensible, manageable, and meaningful, reflecting their sense of coherence and overall well-being. Higher score indicates greater coherence.
Measured: 6 months post-intervention
Self-Representation (Ontological Addiction Scale)
The Ontological Addiction Scale (OAS) is a 12-item scale designed to measure the excessive preoccupation with self (i.e., the concern to satisfy the incorrect idea we usually have of ourselves). A higher score indicates a greater preoccupation with one's self-representation, suggesting a stronger tendency to engage in self-referential thinking.
Measured: immediate post-intervention
Self-Representation (Ontological Addiction Scale)
The Ontological Addiction Scale (OAS) is a 12-item scale designed to measure the excessive preoccupation with self (i.e., the concern to satisfy the incorrect idea we usually have of ourselves). A higher score indicates a greater preoccupation with one's self-representation, suggesting a stronger tendency to engage in self-referential thinking.
Measured: 3 months post-intervention
Self-Representation (Ontological Addiction Scale)
The Ontological Addiction Scale (OAS) is a 12-item scale designed to measure the excessive preoccupation with self (i.e., the concern to satisfy the incorrect idea we usually have of ourselves). A higher score indicates a greater preoccupation with one's self-representation, suggesting a stronger tendency to engage in self-referential thinking.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 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
- NCT07199166
- Sponsor's protocol ID
- RECHMPL24_0016
- Acronym
- ICS
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Effectiveness of Autobiographical Rewriting Workshops on the Socio-Professional Functioning of Patients With Borderline Personality Disorder Undergoing Third-Wave Cognitive and Behavioral Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07199166
- Acronym / sponsor ID
- ICS / RECHMPL24_0016
- Keywords
- borderline personality disorder, autobiographical rewriting, third wave CBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 30 Sep 2025 (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.
This study evaluates the effectiveness of autobiographical rewriting workshops combined with third-wave Cognitive Behavioral Therapy (CBT) in improving social and professional functioning in individuals with Borderline Personality Disorder (BPD). BPD affects approximately 2 to 6% of the general population and is frequently associated with suicidal behaviors, unstable relationships, and low self-esteem. This disorder is often linked to early traumatic experiences that impact autobiographical memory and self-perception. While Dialectical Behavioral Therapy (DBT) is a standard treatment for BPD, it does not fully address all the needs of patients.
The aim of this study is to determine whether autobiographical rewriting, which allows individuals to restructure and reinterpret their memories in a more resilient way, can improve autobiographical memory, self-esteem, and reduce emotional symptoms. Participants will be randomized into two groups: one group will undergo autobiographical rewriting workshops in addition to third-wave CBT sessions, while the other group will participate in non-specific writing sessions also in addition to third-wave CBT sessions. The study will compare the two groups to evaluate the effectiveness of autobiographical rewriting workshops in enhancing social and professional well-being.
Expected outcomes include improvements in interpersonal relationships, greater professional stability, and a reduction in emotional symptoms assessed immediately post-intervention, then 3 months and 6 months after. This study may offer a complementary therapeutic approach to existing treatments, helping patients manage their symptoms more effectively and improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Behavioral: Autobiographical Rewriting WorkshopsSessions of maintenance in third-wave CBT as part of the usual treatment plan (10 weekly sessions of 45 minutes over 10 weeks) + Autobiographical Rewriting Workshops (10 autobiographical rewriting sessions over 10 weeks, one session per week) |
| CONTROL GROUP | Placebo comparator | Behavioral: Non-specific writing workshopsThird-wave CBT maintenance sessions as part of the usual treatment plan (10 weekly sessions of 45 minutes over 10 weeks) + Non-specific Writing Workshops (10 autobiographical non-specific writing sessions over 10 weeks, one session per week) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects with borderline personality disorder (assessed by SCID-2),
- Subjects aged between 18 and 45 years (inclusive).
Key exclusion criteria (8 listed)
- Psychotic disorder (assessed by SCID),
- Subjects deprived of their liberty (by judicial or administrative decision, or involuntary hospitalization),
- Subjects under legal protection (guardianship, curatorship, or judicial protection),
- Subjects not affiliated with a social security,
- Pregnant or breastfeeding women,
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 |
|---|---|---|
| Autobiographical Rewriting Workshops10 two-hour autobiographical rewriting workshop sessions, held weekly. This program encourages participants to explore their own history in a way that fosters narrative resilience, highlighting their ability to overcome challenges, transform failures into learning opportunities, express themselves creatively, reexamine their memories, and rebuild a more positive sense of identity that better aligns with the needs of accurate self-recognition of their potential. This program is particularly inspired by the concepts of resilience (Boris Cyrulnik), identification (Karine Gros), the Hero's Journey (Joseph Campbell), narrative therapy (David Denborough), and works on various types of story structures (Blake Snyder). | Behavioural | INTERVENTION GROUP |
| Non-specific writing workshops10 sessions of 2 hours of non-specific writing, held weekly. To increase the active role of the participants, they will be encouraged to write on the theme of the session during the time between sessions. The writing themes are non-specific, unlike the intervention group, and include topics such as poetry, historical events, nature reports, imaginary interviews, children's stories, etc. | Behavioural | CONTROL GROUP |
Primary outcome
Improvement in Social Functioning
Time frame: immediate post-intervention
The change in the score on the Social Functioning Questionnaire (SFQ) will be assessed between pre-intervention and post-intervention immediately, and compared between the two groups. The SFQ measures social functioning over the past two weeks, with 16 items divided into 8 domains: professional activities, daily life tasks, leisure, family and couple relationships, extrafamily relationships, financial and administrative management, general health, and community life and information. For each domain, participants assess the frequency and satisfaction of their activities
26 secondary outcomes
Autobiographical Memory
Time frame: immediate post-intervention
Autobiographical Memory
Time frame: 3 months post-intervention
Improvement in Social Functioning
Time frame: 3 months post-intervention
Improvement in Social Functioning
Time frame: 6 months post-intervention
Autobiographical Memory
Time frame: 6 months post-intervention
Borderline Symptom Severity
Time frame: immediate post-intervention
Borderline Symptom Severity
Time frame: 3 months post-intervention
Borderline Symptom Severity
Time frame: 6 months post-intervention
Self-Concept Clarity
Time frame: immediate post-intervention
Self-Concept Clarity
Time frame: 3 months post-intervention
Self-Concept Clarity
Time frame: 6 months post-intervention
Self-Defining Future Projections
Time frame: immediate post-intervention
Self-Defining Future Projections
Time frame: 3 months post-intervention
Self-Defining Future Projections
Time frame: 6 months post-intervention
Self-Esteem
Time frame: immediate post-intervention
Self-Esteem
Time frame: 3 months post-intervention
Self-Esteem
Time frame: 6 months post-intervention
Reflective Emotions (Shame)
Time frame: immediate post-intervention
Reflective Emotions (Shame)
Time frame: 3 months post-intervention
Reflective Emotions (Shame)
Time frame: 6 months post-intervention
Sense of Coherence
Time frame: immediate post-intervention
Sense of Coherence
Time frame: 3 months post-intervention
Sense of Coherence
Time frame: 6 months post-intervention
Self-Representation (Ontological Addiction Scale)
Time frame: immediate post-intervention
Self-Representation (Ontological Addiction Scale)
Time frame: 3 months post-intervention
Self-Representation (Ontological Addiction Scale)
Time frame: 6 months post-intervention
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Autobiographical Rewriting Workshops and Non-specific writing workshops in people with Borderline Personality Disorder and Borderline Personality Disorder (BPD), run by University Hospital, Montpellier.
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 2 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: opening soon, 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Social Functioning (time frame: immediate post-intervention). 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.