Brief Cognitive Behaviour Therapy to Prevent Suicide Reattempts: A Feasibility Study in Swedish Psychiatric Inpatient Care (BCBT)
The goal of this study is to determine whether Brief Cognitive Behaviour Therapy (BCBT), a four-session psychological treatment aimed at reducing suicide attempts, is acceptable and feasible to deliver during psychiatric inpatient care for adults who have been hospitalised following a suicide attempt or who are at high risk of suicide. The main questions it aims to answer are:
- Is BCBT acceptable among suicidal psychiatric inpatients, and in what ways can the treatment and its delivery be improved to enhance patient engagement and adherence?
- Is BCBT feasible from the perspectives of treating clinicians, clinic managers, and other relevant personnel, and what are the key facilitators and barriers to its implementation within routine inpatient psychiatric care in Sweden?
Participants will:
- Receive four structured BCBT therapy sessions delivered during hospitalisation, in addition to usual care
- Be contacted for follow-up assessments at 1 and 3 months after completing treatment
- Take part in an interview about the participants' experience with the treatment 1 month after completing it
Clinical staff, treating psychologists, and managers will also be interviewed to explore the participants' experiences, as well as barriers and facilitators to implementation. Overall, the findings from this study will inform the design of a future randomised trial to test the effectiveness of BCBT in reducing suicide attempts after discharge from inpatient psychiatric care.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Suicide attempts and self-harm represent major public health concerns, with approximately 11,000 individuals in Sweden requiring emergency or inpatient care each year following suicidal behaviour. The period immediately following discharge from psychiatric inpatient care is associated with an extremely elevated risk of suicide, with studies indicating up to a 200-fold increase compared to the general population. Despite this high-risk period, there is currently a lack of structured, evidence-based psychological interventions specifically designed for inpatient psychiatric settings, where care primarily focuses on pharmacological treatment and acute stabilisation.
Brief Cognitive Behaviour Therapy (BCBT) is a structured, four-session psychological intervention based on cognitive behavioural principles and specifically adapted to target suicidal behaviour. BCBT is grounded in the Fluid Vulnerability Theory of suicide, which conceptualises suicide risk as a dynamic process influenced by both enduring vulnerabilities and acute stressors. The intervention aims to reduce suicide risk by targeting modifiable cognitive, emotional, and behavioural processes, enhancing coping skills, and preventing the activation or escalation of suicidal crises.
This study is a single-arm feasibility study designed to evaluate the acceptability and feasibility of BCBT among adult psychiatric inpatients in Sweden. A total of 20 participants aged 18 years or older will be recruited from inpatient psychiatric units at Psykiatri Sydväst and Psykosvård Stockholm.
Participants will receive four individual BCBT sessions delivered by trained clinical psychologists during the participants' inpatient stay. Each session lasts approximately 60-90 minutes and focuses on specific therapeutic components. The first session includes psychoeducation, a narrative of the suicide attempt, and development of an individualised case conceptualisation and safety plan. The second session focuses on cognitive flexibility and identifying reasons for living, including the creation of a "hope box". The third session addresses restriction of access to lethal means and development of coping strategies, including coping cards. The fourth session focuses on consolidation of skills and relapse prevention, including guided imagery exercises to prepare for future crises. If discharge occurs before completion, sessions may be continued after discharge. All participants will continue to receive treatment as usual in accordance with standard inpatient care.
In addition, semi-structured qualitative interviews will be conducted with patients, focusing on the acceptability, perceived effects, and satisfaction with the treatment. The investigators will also conduct semi-structured qualitative interviews with treating psychologists, clinical staff, and managers (approximately 8-12 participants). These interviews aim to explore feasibility, and barriers and facilitators to implementation of BCBT in routine inpatient psychiatric care.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Christian Rück, Professor
- Telefonní číslo: +46704843392
- E-mail: christian.ruck@ki.se
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- admitted following a suicide attempt within one week of admission or presenting with suicidal ideation with a plan and a prior suicide attempt within the last two years
- 18 years or older
Exclusion Criteria:
- current mania, current acute psychosis, or cognitive impairment
- expected inpatient stay shorter than four working days
- ongoing or planned electroconvulsive therapy
- psychiatric or somatic conditions leading to inability to provide informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: BCBT
Participants will receive four individual BCBT sessions delivered by trained clinical psychologists during their inpatient stay.
Each session lasts approximately 60-90 minutes and focuses on specific therapeutic components.
The first session includes psychoeducation, a narrative of the suicide attempt, and development of an individualised case conceptualisation and safety plan.
The second session focuses on cognitive flexibility and identifying reasons for living, including the creation of a "hope box".
The third session addresses restriction of access to lethal means and development of coping strategies, including coping cards.
The fourth session focuses on consolidation of skills and relapse prevention, including guided imagery exercises to prepare for future crises.
If discharge occurs before completion, sessions may be continued after discharge.
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Brief Cognitive Behaviour Therapy to prevent suicide reattempts
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Treatment completion
Časové okno: Posttreatment assessment performed within two working days after the final treatment session.
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Proportion of participants completing 3 or more BCBT sessions
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Posttreatment assessment performed within two working days after the final treatment session.
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Treatment satisfaction
Časové okno: Posttreatment assessment performed within two working days after the final treatment session.
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Patient-reported treatment satisfaction assessed using the Client Satisfaction Questionnaire (CSQ-8).
The CSQ-8 is an 8-item scale, with each item rated on a four-point Likert scale (1-4), giving a total score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction.
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Posttreatment assessment performed within two working days after the final treatment session.
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Retention
Časové okno: 1- and 3-month follow-up after the final treatment session
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Proportion of participants completing follow-up assessments at 1 and 3 months
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1- and 3-month follow-up after the final treatment session
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Decline rate
Časové okno: From first potentially eligible participant approached until recruitment of 20 patients is completed (anticipated duration: 6 months)
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Proportion of potentially eligible participants who are approached but decline study participation
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From first potentially eligible participant approached until recruitment of 20 patients is completed (anticipated duration: 6 months)
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Recruitment pace
Časové okno: From first potentially eligible participant approached until recruitment of 20 patients is completed (anticipated duration: 6 months)
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Average monthly recruitment rate
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From first potentially eligible participant approached until recruitment of 20 patients is completed (anticipated duration: 6 months)
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Likelihood of treatment component use
Časové okno: During the 4-session treatment period (planned for 4 consecutive days), assessed at each session
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Patient-reported likelihood of using each treatment component (safety plan, reasons for living list, hope box, restriction of lethal means, coping cards), rated from 0-10 for each treatment component, with higher scores indicating a higher likelihood of using the component.
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During the 4-session treatment period (planned for 4 consecutive days), assessed at each session
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Use and perceived helpfulness of treatment components
Časové okno: 1- and 3-month follow-up after the final treatment session
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Patient-reported extent of use and perceived helpfulness of treatment components (safety plan, reasons for living list, hope box, restriction of lethal means, coping cards) rated with 6 items on a 0-10 scale, with higher scores indicating a higher extent of use and perceived helpfulness of the component.
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1- and 3-month follow-up after the final treatment session
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Adverse events and negative effects of treatment
Časové okno: During the 4-session treatment period (planned for 4 consecutive days), assessed at each session; posttreatment assessment (performed within 2 working days after the final treatment session); and 1- and 3-month follow-up after the final treatment session
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Negative effects of treatment are assessed at each treatment session, as well as at posttreatment and follow-up
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During the 4-session treatment period (planned for 4 consecutive days), assessed at each session; posttreatment assessment (performed within 2 working days after the final treatment session); and 1- and 3-month follow-up after the final treatment session
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Semi-structured interviews with personnel
Časové okno: Interviews will be conducted within 1 month after recruitment of the final patient (n=20) is completed (anticipated recruitment duration: approximately 6 months)
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Semi-structured interviews with treating psychologists, clinical personnel at the wards and managers focusing on perceived feasibility, barriers and facilitators to implementation
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Interviews will be conducted within 1 month after recruitment of the final patient (n=20) is completed (anticipated recruitment duration: approximately 6 months)
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Semi-structured interviews with patients
Časové okno: Interviews will be conducted on the same day, directly following the 1-month follow-up assessment (i.e., one month after the final treatment session).
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Semi-structured interviews with patients to explore perceived effects, acceptability and satisfaction with the treatment
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Interviews will be conducted on the same day, directly following the 1-month follow-up assessment (i.e., one month after the final treatment session).
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Suicidal ideation
Časové okno: Assessed at screening (baseline), posttreatment (within 2 working days after the final treatment session), and at 1-month and 3-month follow-up after the final treatment session. Primary endpoint: 3-month follow-up after the final treatment session.
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Suicidal ideation will be measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) intensity subscale covering 5 items rated from 0/1 to 5, and summed for a total score of 2-25, with higher scores representing a higher intensity of suicidal ideation.
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Assessed at screening (baseline), posttreatment (within 2 working days after the final treatment session), and at 1-month and 3-month follow-up after the final treatment session. Primary endpoint: 3-month follow-up after the final treatment session.
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Suicide attempts
Časové okno: Assessed at screening (baseline), posttreatment (within 2 working days after the final treatment session), and at 1-month and 3-month follow-up after the final treatment session. Primary endpoint: 3-month follow-up after the final treatment session.
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The total number of suicide attempts between discharge and the 3-month follow-up.
A suicide attempt is defined here using the Columbia-Suicide Severity Rating Scale (C-SSRS) definition of "Actual attempt" or "Interrupted attempt".
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Assessed at screening (baseline), posttreatment (within 2 working days after the final treatment session), and at 1-month and 3-month follow-up after the final treatment session. Primary endpoint: 3-month follow-up after the final treatment session.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-08835-01.
- 2025-00188 (Jiné číslo grantu/financování: The Swedish Research Council for Health, Working Life and Welfare (FORTE))
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