Table 2 All items from the World Health Organization Trial Registration Data Set in relation to the Brief Admission Skåne Randomized Controlled Trial (BASRCT)
Data category | Information |
|---|---|
Primary registry and trial identifying number | Clinicaltrials.gov NCT02985047 |
Date of registration in primary registry | November 25, 2016 |
Secondary identifying numbers | N/A |
Sources(s) of monetary or material support | Mats Paulsson Stiftelse; Swedish Research Council; Sweden’s National Self-Harm Project (NSP); Regional Research Funds; Söderström-Königska Foundation; Ellen och Henrik Sjöbrings Minnesfond; OM Persson Stiftelse; Maggie Stephens Stiftelse |
Primary Sponsor | Region Skåne Clinical Psychiatric Research Center Baravägen 1 22,185 Lund Sweden |
Secondary Sponsor | None |
Contact for public queries | Sophie Liljedahl Department of Psychology Lund University Box 213 221 85, Lund Sweden Phone: +46 0708 88 5618 Email: sophie.liljedahl@psy.lu.se |
Contact for scientific queries | Sophie Liljedahl (contact information above) Sophie Westling, M. D., Ph. D. Lund University Box 213 221 85, Lund Sweden Phone:+46 0735 62 6099 Email: sophie.westling@med.lu.se |
Public Title | Brief Admission Skåne (BAS) Brukarstyrd Inläggning (BI) – Swedish |
Scientific Title | Brief Admission Skåne Randomised Controlled Trial (BASRCT) |
Countries of recruitment | Sweden |
Health condition or problem(s) studied | Individuals with three or more symptoms of borderline personality disorder; self-harming and/or suicidal individuals receiving public mental health services in the region of Skåne (South Sweden). |
Intervention(s) | Brief Admission + Treatment As Usual OR Treatment As Ususal (BA + TAU OR TAU) |
Key inclusion and exclusion criteria | Ages eligible: ≥ 18 years to 60 years. Sexes eligible: Individuals or any sex or gender Accepts healthy volunteers: no Inclusion criteria: adult patient (≥ 18 years to age 60), individuals receiving public mental health services in the region of Skåne, currently engages in self-harm and/or recurrent suicidal behavior, fulfills at least three criteria for a diagnosis of BPD, 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 6 months. Exclusion criteria: No regular contact with outpatient psychiatric services, unstable housing, somatic disorder that significantly contributes to inclusion criteria |
Study type | Interventional Allocation: randomized Masked: single blind Primary purpose: self-harm and suicide crisis and risk management |
Date of first enrolment | October 2015 |
Target sample size | 124 |
Recruitment status | Recruiting |
Primary outcome(s) | 1. Number of days with hospital admission Time frame: Change between the period from 12 months retrospectively to baseline and the period from baseline to 12 months prospectively. 2. Number of days with Brief Admission, general psychiatric admission, forced (involuntary) admission |
Secondary outcome(s) | 1. Frequency of forced acts (e.g. restraints and forced medication). Time frame: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively. 2. Individuals’ Experiences of the intervention. Time frame: Data collected at each Brief Admission during a period of 140 weeks. Outcome: Scores from the questionnaires developed for the method: Individual’s Experience Scale (IES). 3. Clinicians’ experiences of the intervention. Time frame: Data collected at each Brief Admission during a period of 140 weeks. Outcome: Scores from the questionnaires developed for the method: Clinician’s Experience Scale (CES) 4. Frequency of all self-harming behaviours including suicide attempts. Time frame: Change in frequency between baseline, 6 months and 12 months prospectively. Outcome: Scores from the Five Self-Harm Behaviour Groupings Measure (5S–HM) 5. Severity of self-harming behaviours Time frame: Change in severity between baseline, 6 months and 12 months prospectively. Outcome: Scores from the Five Self-Harm Behaviour Groupings Measure (5S–HM) 6. Level of functioning in activities of daily life. Time frame: Change in ratings between baseline, 6 months and 12 months prospectively. Outcome: Scores from the World Health Organization Disability Assessment Schedule II (WHODAS 2.0) 7. Ability to cope effectively with life stress. Time frame: Change in ratings between baseline, 6 months and 12 months prospectively. Outcome: Scores from The Brief COPE 8. Ability to regulate emotions Time frame: Change in ratings between baseline, 6 months and 12 months prospectively. Outcome: Scores on the Difficulties in Emotion Regulation Scale (DERS) 9. Global psychiatric symptoms. Time frame: Change in ratings between baseline, 6 months and 12 months prospectively. Outcome: Scores from the Clinical Global Impression Severity Scale (CGISS) 10. Satisfaction with health care Time frame: Change in ratings between baseline, 6 months and 12 months prospectively. Outcome: Scores on the Client Satisfaction Questionnaire (CSQ) |