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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Christian Rück, Professor
- 電話番号：+46704843392
- メール：christian.ruck@ki.se
研究場所
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-
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Stockholm、スウェーデン
- 募集
- Psykiatri Sydväst
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コンタクト：
- Christian Rück
- 電話番号：+46704843392
- メール：christian.ruck@ki.se
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment completion
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Decline rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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