## Protocol Section
### Identification Module
**NCT ID:** NCT06424509

**Brief Title:** Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder

**Official Title:** Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder

#### Organization Study ID Info
**ID:** 2024-00589-01
#### Organization
**Class:** OTHER
**Full Name:** Lund University
### Status Module
#### Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Linkoeping University

#### Lead Sponsor

**Class:** OTHER

**Name:** Lund University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The current study aims to evaluate the impact of long (\>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm.

The basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides.

All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).

Data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. We will compare the top quartile of participants with the bottom quartile.

### Conditions Module

**Conditions:**

- Borderline Personality Disorder

- Self-harm

- Non-suicidal Self-injury

- Suicide

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 390

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

#### Arm Group 1

**Description:** The quartile of participants using the highest degree of long (\>5 days) and/or compulsory psychiatric inpatient care.

**Intervention Names:**

- Other: High degree of long (>5 days) and/or compulsory psychiatric inpatient care

**Label:** High admission

#### Arm Group 2

**Description:** The quartile of participants using the lowest degree of long (\>5 days) and/or compulsory psychiatric inpatient care.

**Label:** Low admission

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High admission

**Description:** High degree of long (\>5 days) and/or compulsory psychiatric inpatient care

**Name:** High degree of long (>5 days) and/or compulsory psychiatric inpatient care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Number of healthcare visits due to self-harm in specialized inpatient or outpatient care, as defined in the NPR (X60-X84; Intentional self-harm) divided by the number of individuals diagnosed with BPD per clinic and calendar year.

**Measure:** Number of healthcare visits due to self-harm

**Time Frame:** 1 year

**Description:** Number of deaths by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) in individuals diagnosed with BPD divided by the number of individuals diagnosed with BPD per clinic and calendar year.

**Measure:** Number of deaths by suicide

**Time Frame:** 1 year

**Description:** Number of deaths by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) within 30 days after discharge, in individuals diagnosed with BPD divided by the number of individuals diagnosed with BPD, per clinic and calendar year

**Measure:** Number of deaths by suicide within 30 days after discharge

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Number of days between admissions to psychiatric inpatient care for people diagnosed with BPD divided by the number of individuals diagnosed with BPD per clinic and calendar year.

**Measure:** Number of days between admissions to psychiatric inpatient care

**Time Frame:** 1 year

**Description:** Number of days between death by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) and discharge in individuals diagnosed with BPD. For this variable, death by suicide during inpatient admission will be labelled 0.

**Measure:** Number of days between death by suicide and discharge

**Time Frame:** 1 year

**Description:** Number of days in somatic (non-psychiatric) inpatient care after self-harm (X60-X84; Intentional self-harm) divided by the number of individuals diagnosed with BPD per clinic and calendar year.

**Measure:** Number of days in somatic (non-psychiatric) inpatient care after self-harm

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Psychiatric clinic in Sweden authorized to administer compulsory care for adults. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).

Exclusion Criteria:

* No authorization to administer compulsory care for adults

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sofie.westling@med.lu.se

**Name:** Sofie Westling, MD, PhD

**Phone:** +46735626099

**Role:** CONTACT

**Contact 2:**

**Email:** josefin.vikstrom@liu.se

**Name:** Josefin Vikström Eckevall, MD, PhD

**Phone:** +46703320527

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Lund University

**Name:** Sofie Westling, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-03

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 265547

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-07T11:23

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13462

- Name: Personality Disorders

- Relevance: HIGH

- As Found: Personality Disorder

- ID: M5161

- Name: Borderline Personality Disorder

- Relevance: HIGH

- As Found: Borderline Personality Disorder

- ID: M16191

- Name: Suicide

- Relevance: HIGH

- As Found: Suicide

- ID: M19089

- Name: Self-Injurious Behavior

- Relevance: HIGH

- As Found: Self-harm

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013405

- Term: Suicide

- ID: D000010554

- Term: Personality Disorders

- ID: D000001883

- Term: Borderline Personality Disorder

- ID: D000016728

- Term: Self-Injurious Behavior

### Misc Info Module

- Version Holder: 2024-05-31
