Clinical trial NCT02985047: Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide
Official title: Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Injurious Behavior
Suicidal Ideation
Suicide, Attempted
Borderline Personality Disorder
Emergency Services, Psychiatric
Keywords: Brief admission
admission
deliberate self-harm
self-harm
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Radboud University Medical Center
First posted: 2016-12-07
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU.

Detailed description: When individuals with recurrent self-harm and suicidal behaviour seek acute admission to hospital due to a crisis and associated increased suicidal ideation, recommendations for clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are considerable, and long hospital admissions without a clear treatment structure may predict decompensation in functioning. This has resulted in a clinical practice of avoiding admission for individuals diagnosed with Borderline Personality Disorder (BPD).

Brief admission (BA) as an intervention has a longstanding history in the delivery of mental health services in the Netherlands. The core elements of brief admission were determined through consultation with Dutch researchers, interviews with individuals with experience, Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar with implementing this crisis management intervention. Core elements of the intervention were standardized into a protocol, and an educational manual was developed to train clinicians involved in the trial. An objectively rated fidelity measure was developed in order to ensure adherence.

Eligibility criteria: Inclusion Criteria:

* Current episodes of self-harm and/or recurrent suicidality.
* Fulfilling at least three criteria for borderline personality disorder.
* Admitted to psychiatric hospital for acute care for at least 7 days or presenting to the psychiatric emergency department at least 3 times during the last six months.

Exclusion Criteria:

* No regular contact with outpatient psychiatric services.
* Homelessness. Housing crises are outside the scope of this RCT.
* Medical disorder from other organs that significantly contributes to inclusion criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic patient).

Primary outcomes:
measure: Number of days with hospital admission
timeFrame: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Secondary outcomes:
measure: Frequency of forced acts (e.g. restraints and forced medication)
timeFrame: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
measure: Individuals' Experiences of the intervention
timeFrame: Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
measure: Clinicians' Experiences of the intervention
timeFrame: Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.
measure: Frequency of all self-harming behaviours including suicide attempts
timeFrame: Change in frequency between baseline, 6 months and 12 months prospectively.
measure: Severity of self-harming behaviours
timeFrame: Change in severity between baseline, 6 months and 12 months prospectively.
measure: Level of functioning in activities of daily life
timeFrame: Change in ratings between baseline, 6 months and 12 months prospectively.
measure: Ability to cope effectively with life stress
timeFrame: Change in ratings between baseline, 6 months and 12 months prospectively.
measure: Ability to regulate emotions
timeFrame: Change in ratings between baseline, 6 months and 12 months prospectively.
measure: Global psychiatric symptoms
timeFrame: Change in ratings between baseline, 6 months and 12 months prospectively.
measure: Satisfaction with health care
timeFrame: Change in ratings between baseline, 6 months and 12 months prospectively.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Division of Psychiatry, Region Skåne
state: Skåne
Study officials:
affiliation: Region Skåne
name: Sofie Westling, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Westling S, Daukantaite D, Liljedahl SI, Oh Y, Westrin A, Flyckt L, Helleman M. Effect of Brief Admission to Hospital by Self-referral for Individuals Who Self-harm and Are at Risk of Suicide: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e195463. doi: 10.1001/jamanetworkopen.2019.5463.
citation: Helleman M, Lundh LG, Liljedahl SI, Daukantaite D, Westling S. Individuals' experiences with brief admission during the implementation of the brief admission skane RCT, a qualitative study. Nord J Psychiatry. 2018 Jul;72(5):380-386. doi: 10.1080/08039488.2018.1467966. Epub 2018 Apr 27.
citation: Liljedahl SI, Helleman M, Daukantaite D, Westrin A, Westling S. A standardized crisis management model for self-harming and suicidal individuals with three or more diagnostic criteria of borderline personality disorder: The Brief Admission Skane randomized controlled trial protocol (BASRCT). BMC Psychiatry. 2017 Jun 15;17(1):220. doi: 10.1186/s12888-017-1371-6.