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Not yet recruiting NCT07567885

Brief Cognitive Behaviour Therapy to Prevent Suicide Reattempts: A Feasibility Study in Swedish Psychiatric Inpatient Care

No phase Interventional Suicide Attempt

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Cognitive Behaviour Therapy.
Who it may be relevant to
Registry conditions: Suicide Attempt. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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: 1. 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? 2. 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.

Detailed description

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.

Interventions

  • Behavioral Brief Cognitive Behaviour Therapy
    Brief Cognitive Behaviour Therapy to prevent suicide reattempts

Primary outcome measures

  • Treatment completion [Time frame: Posttreatment assessment performed within two working days after the final treatment session.]
  • Treatment satisfaction [Time frame: Posttreatment assessment performed within two working days after the final treatment session.]
  • Retention [Time frame: 1- and 3-month follow-up after the final treatment session]
Secondary outcome measures (9)
  • Decline rate [Time frame: From first potentially eligible participant approached until recruitment of 20 patients is completed (anticipated duration: 6 months)]
  • Recruitment pace [Time frame: From first potentially eligible participant approached until recruitment of 20 patients is completed (anticipated duration: 6 months)]
  • Likelihood of treatment component use [Time frame: During the 4-session treatment period (planned for 4 consecutive days), assessed at each session]
  • Use and perceived helpfulness of treatment components [Time frame: 1- and 3-month follow-up after the final treatment session]
  • Adverse events and negative effects of treatment [Time frame: 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]
  • Semi-structured interviews with personnel [Time frame: Interviews will be conducted within 1 month after recruitment of the final patient (n=20) is completed (anticipated recruitment duration: approximately 6 months)]
  • Semi-structured interviews with patients [Time frame: 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).]
  • Suicidal ideation [Time frame: 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.]
  • Suicide attempts [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07567885 · 2025-08835-01. · 2025-00188

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗