Please select the eligibility criteria that correspond to the clinical trial below.
Title: The BEACON Study: Protocol for Cluster RCT of a Service to Deliver Smartphone-Assisted Problem-Solving Therapy Compared to Usual Care in Men Who Present With Intentional Self-Harm to the ED in Ontario (Protocol A)
Brief Summary: This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST) service across Emergency Departments in Ontario. A total of 25 Emergency Departments have been randomized to either usual care or the smartphone-assisted PST service intervention. The main cluster randomized controlled trial will use data collected from the Institute of Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and re-presentations to hospital for self-harm as well as other health service use one-year post study launch.


Options:
A: Inclusion Criteria:

1. Veteran service member
2. Recently admitted to an inpatient psychiatry unit at the VAMC site following a suicide attempt
3. 18 or more years of age
4. Consents to participate in baseline and follow-up interviews and gives permission to review records for previous year and subsequent year.
5. Consents to randomization and participation in TMBI + follow-up or Care as Usual
6. Consents to audio recording in order for PI to conduct adherence rating

Exclusion Criteria:

1. Significant psychosis, cognitive, or other problems that prevent participant from understanding the study procedures or renders them unable to provide informed consent (suggesting that psychosocial therapeutic care is contra-indicated)
2. Judicially-ordered to treatment (e.g., subsequent to domestic violence) such that participation in study procedures could not be considered voluntary and participant is not free to drop out without significant negative consequences.
B: Inclusion Criteria:

* Patients meeting diagnostic criteria of borderline personality disorder (BoPD) per Diagnostic and Statistical Manual of Mental Disorders(DSM-5) at screening visit, confirmed by Structured Interview for DSM-5 Personality Disorder (SCID-5-PD).
* Zanarini rating scale for Borderline personality disorder (ZAN-BPD) of ≥ 9 at screening (Visit 1) and randomization (Visit 2), with question #2 Affective Instability score of ≥2.
* Male or female patients, 18-65 years of age at the time of consent
* Women of childbearing potential (WOCBP) able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1%, plus one barrier method.

  --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal occlusion/ ligation is NOT a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Signed and dated written informed consent in accordance with International Council on Harmonization (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
* further inclusion criteria apply.

Exclusion Criteria:

* Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality disorders, as confirmed by SCID-5-PD at screening visit.
* Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the screening visit.
* Any other mental disorder that is the primary focus of treatment in the last 6 months prior to randomization, as per the clinical judgement of the investigator.
* Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to randomization.
* Initiation or change in any type or frequency of psychotherapy for BoPD within the last 3 months prior to screening.
* Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study.
* Any suicidal behavior in the past 1 year.
* Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months.
* further exclusion criteria apply.
C: Inclusion Criteria:

* In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
* DES-(Dissociative Experience Scale)-score: \> or equal 18 according to amendment4 (former value according to amendment 2 was \> or equal 25).
* Urinary test of opiates negative
* No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
* No Lithium for two months

Exclusion Criteria:

* Lifetime diagnosis of psychotic disorder
* Current major depressive disorder (MDD)
* Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
* Comedication with opioid analgetics
* Known naltrexone intolerance
* Liver disease
* Pregnancy and lactation period
* Other severe medical or neurological diseases
* Simultaneous participation in another study
D: Inclusion Criteria:

* Patient has presented with an index episode of intentional self-harm at an eligible Emergency Department in Ontario, Canada.
* Patient is biologically male.
* Patient is 18 years of age or older.
* Patient has a valid OHIP number.

Exclusion Criteria:

* Patient has presented to the Emergency Department for a reason other than intentional self-harm at an eligible Emergency Department in Ontario, Canada.
* Patient is biologically female.
* Patient is under 18 years of age.
* Patient does not have a valid OHIP number.

Answer: D