Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Brief Summary: Study design was a multicenter, randomized, rater-blind clinical trial. There were two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational group intervention (PE) in subjects with Borderline Personality Disorder (BPD).


Options:
A: Inclusion Criteria:

1. Age 18-60
2. Frequent current NSSI (including cutting in which the skin is broken; self-hitting in which there is bruising; or burning in which there is evidence of a burn. Will not enroll if skin-picking or scratching is the only form of self-injury): has engaged in ≥2 episodes of NSSI in the two months prior to enrollment
3. Capacity to provide informed consent
4. If carries a diagnosis of bipolar I or II disorder, taking or willing to begin a therapeutic dose of a mood stabilizer.
5. Normal hearing.
6. Physical capacity (e.g., manual dexterity) to set-up and self-administer tDCS. -

Exclusion Criteria:

1. Unstable medical conditions based on medical history or physical examination
2. Current psychotic disorder, mania, hypomania, intellectual disability
3. Dermatologic condition resulting in non-intact skin on the scalp
4. Significant suicidal ideation with a plan and intent that cannot be managed safely as an outpatient
5. Pregnancy, currently lactating, or planning to conceive during the course of study participation.
6. A neurological disease or prior head trauma with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score ≥ 1.5 standard deviations below the mean on the Trailmaking A\&B will be excluded from study participation.
7. Current alcohol or substance use disorder that is severe according to DSM-V criteria
8. Individuals who initiated or increased the dose of concurrent psychiatric medications (including antidepressants, anxiolytics, antipsychotic medications, mood stabilizers, and benzodiazepines) within two weeks prior to enrollment
9. Individuals who initiated psychotherapy within two weeks prior to enrollment
10. Current seizure disorder.
11. Use of anticonvulsant medications that target the GABA system (e.g., gabapentin).
12. Individuals currently using benzodiazepines who are unwilling or unable to refrain from the use of benzodiazepine medications for at least 72 hours before the first tDCS session and throughout the duration of the 2-week tDCS intervention.
13. Metal implants or paramagnetic objects contained within the body (including heart pacemaker, shrapnel, or surgical prostheses) which may present a risk to the subject or interfere with the MRI scan, according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects," F.G. Shellock, Lippincott Williams and Wilkins NY 2001. Additionally transdermal patches will be removed during the MR study at the discretion of the investigator.
14. Claustrophobia significant enough to interfere with MRI scanning
15. Weight that exceeds 325 lbs or inability to fit into MRI scanner
16. Suicide attempt within the past 3 months
17. Serious self-harm resulting in hospitalization within the past 3 months.

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B: Inclusion Criteria:

* Outpatients aged 18 to 45 years;
* Diagnoses of BPD according to Diagnostic and Statistical Manual for Mental Disorders (4th version Revised) (DSM-IV-TR) criteria and evaluated by two semi-structured diagnostic interviews
* Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) and the Revised Diagnostic Interview for Borderlines (DIB-R)
* Clinical severity measured with Clinical Global Impression for BPD (CGI-BPD) higher than 4;
* Functional impairment measured with a Global Assessment Functioning (GAF) lower than 65.

Exclusion Criteria:

* No severe physical conditions, such as organic brain syndrome or neurological disease that could affect neuropsychological performance;
* Intelligence Quotient (IQ) \< 85;
* Major Depression Disorder (MDD) or substance misuse within the last 6 months;
* Schizophrenia, severe psychotic disorder or bipolar disorder;
* Previous participation in any psychoeducation or cognitive rehabilitation intervention.
C: Inclusion Criteria:

* Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
* Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.
* At screening and Day 0, participants must have a total score ≥ 12 on the Zanarini Rating Scale for BPD (ZAN-BPD) scale.
* Participants who, in the investigator's judgment, require treatment with a medication for BPD.
* Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

* Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
* Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
* Participants with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, participants with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders.
* Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
* Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:

  * Participants who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or participants with a response of "yes" on the Columbia-suicide severity rating scale (C-SSRS) Suicidal Ideation Item 5, OR
  * Participants with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
  * Participants who have had 3 suicide attempts, OR,
  * Participants who have had 3 or more hospitalizations due to suicidal behavior.
* Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
* Participants who are currently either inpatient or partially hospitalized.
* Participants who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.
D: Inclusion criteria:

* BPD diagnosis according to two semi -structured interviews: the Structured Clinical Interview for DSM-IV Axis II disorders and the Revised Diagnostic Interview for Borderlines
* Age between 18 and 50 years old
* No comorbidities with schizophrenia, drug induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
* Not being participating in any other psychotherapy at the moment of the study.

Exclusion criteria:

• Having participated of skills training in the past.

Answer: B