Clinical trial NCT06322199: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3
Official title: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy ASSIP on Neuropsychological Correlates and Psychological Process Factors (NePsyASSIP HT) - Project 3
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Suicide, Attempted
Suicidal Ideation
Feasibility
Cost-effectiveness
Process Factors
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a past suicide attempt will be recruited at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland) and following recruitment centers:

* Sanatorium Kilchberg Private Clinic for Psychiatry and Psychotherapy
* Psychiatric University Hospital Zurich (PUKZH)
* Vaud University Hospital (CHUV) in Lausanne
* Department of General and Liaison Psychiatry CNP in Neuchâtel

Brief summary: The present study consists of 3 projects in total. It aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the feasibility and cost-effectiveness of ASSIP flex.

The overall aim of Project 3 is to evaluate the feasibility and cost-effectiveness of ASSIP flex over a 12-month follow-up period in terms of suicide reattempts and suicide correlates in a cohort who is attending ASSIP flex after a suicide attempt.

Detailed description: Purpose and aims:

In project 3, the feasibility and cost-effectiveness of ASSIP flex setting over a 12-month follow-up period will be investigated. To investigate that, the present study examines the newly implemented ASSIP flex service developed and implemented at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).

Background:

In Switzerland, approximately three people die by suicide every day, and suicide attempts exceed this number by far. As a previous suicide attempt is one of the strongest predictors of a completed suicide, it is of utmost importance to identify the people at risk. However, research has shown that traditional risk factors (e.g., depression, psychiatric disorder, etc.) reliably predict suicide ideation but poorly predict suicidal behavior. Furthermore, while effective suicide-specific interventions exist, up to 50% of the suicide attempters reject the recommended treatment, and around 60% discontinue treatment after one session. Hence, a different approach is required. In this study, three projects will be conducted. Project 3 evaluates the feasibility and cost-effectiveness of ASSIP flex.

Study design of Project 3:

The present study examines longitudinally and observationally the newly implemented ASSIP flex at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland) and four additional recruitment centers. Patients after a suicide attempt who are immobile and/or not able to participate in the regular ASSIP due to other reasons (e.g., shame or fear of stigmatization) are asked to participate in the ASSIP flex project. Moreover, the ASSIP flex will be implemented and investigated in four additional recruitment centers in Switzerland: 1) Sanatorium Kilchberg in Zurich; 2) Psychiatric Hospital, University of Zurich (PUKZH); 3) Centre Hospitalier Universitaire Vaudois (CHUV); 4) Center Neuchâtelois de Psychiatrie (CNP).

All ASSIP flex patients who have agreed to participate in Project 3 (ASSIP flex) are asked to complete a baseline assessment (filling out questionnaires) before the first ASSIP flex session. This baseline assessment is conducted in the patient's environment (i.e., where the ASSIP flex sessions are carried out).

After the baseline assessment, the participants receive ASSIP flex in their personal environment, and after each ASSIP Flex session, process measurements (therapeutic alliance) are completed. Moreover, repeated measurements are conducted after four-six weeks and 12 months follow-up to assess long-term effects.

In project 3 of this study, no randomization took place, and all participants in this group received ASSIP flex.

To investigate the feasibility and effects of ASSIP flex, therapists will also be asked to complete some questionnaires. After the last flex session of each case, they are asked to fill out a brief questionnaire to rate their experiences with this ASSIP flex case. Finally, therapists are asked one year and two years after their ASSIP training to fill out a short questionnaire about their experiences with the ASSIP flex.

Eligibility criteria: Inclusion Criteria:

Subjects fulfilling the following inclusion criteria are eligible for the study:

* Informed consent as documented by signature
* Age ≥ 18 years
* At least one previous suicide attempt
* Willingness to attend the ASSIP Flex

Exclusion Criteria:

The presence of any one of the following exclusion criteria will lead to exclusion of the subject:

* Serious cognitive impairment
* Any psychotic disorder
* Inability to follow the procedures of the study (e.g., insufficient mastery of the German language, previous enrolment into the current study)

Primary outcomes:
measure: Suicidal ideation (Baseline, t0)
timeFrame: One week before the first ASSIP flex session.
measure: Suicidal ideation and suicidal behavior (Baseline, t0)
timeFrame: One week before the first ASSIP flex session.
measure: Suicidal ideation (Follow-up, t1)
timeFrame: After the three ASSIP flex sessions are completed, up to 4-6 weeks.
measure: Suicidal ideation and suicidal behavior (Follow-up, t1)
timeFrame: After the three ASSIP flex sessions are completed, up to 4-6 weeks.
measure: Suicidal ideation (Follow-up, t2)
timeFrame: 12 months after the baseline assessment.
measure: Suicidal ideation and suicidal behavior (Follow-up, t2)
timeFrame: 12 months after the baseline assessment.
Secondary outcomes:
measure: Treatment costs of treatments 1
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) up to 12 months after t0
Other outcomes:
measure: Sociodemographic data
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
measure: Depressive symptoms
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
measure: General sense of self-efficacy
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
measure: Self-Management
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
measure: Health Literacy
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
measure: Loneliness
timeFrame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
measure: Therapeutic Alliance
timeFrame: After the three ASSIP flex sessions are completed up to 4-6 weeks.
measure: Adherence and Competence
timeFrame: After the three ASSIP flex sessions are completed, up to 4-6 weeks.
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier universitaire vaudois (CHUV)
city: Neuchâtel
country: Switzerland
facility: Center Neuchâtelois de Psychiatrie
city: Zürich
country: Switzerland
facility: Psychiatric Hospital, University of Zurich (PUKZH)
city: Zürich
country: Switzerland
facility: Sanatorium Kilchberg
Study officials:
affiliation: Univerisity of Bern, University Hospital of Psychiatry, Translational Research Center
name: Anja C. Gysin-Maillart, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern, University Hospital of Psychiatry, Translational Research Center
name: Adriana O. Frei, MSc
role: STUDY_CHAIR
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