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 2

Официальное название

Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy ASSIP on Neuropsychological Correlates and Psychological Process Factors (NePsyASSIP HT) - Project 2

Обзор

The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment. The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland). At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2. Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1.

Подробное описание

Purpose and aims:

The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.

After the cross-sectional study in project 1 determining the (neuro-) psychological patterns between suicide ideators (SUID) and suicide attempters, in project 2, the aim is to learn more about the (neuro-) psychological patterns and how they are modulated by a suicide-specific brief intervention ASSIP that was proven to be effective. In addition to the (neuro-) psychological assessment, longitudinal process factors are examined by comparing an ASSIP intervention group to a group of standard care plus resource interview (STAR). The STAR intervention refers to the usual and customary practices within the field, including suicide risk assessment, a non-specific resource focused intervention and if necessary, further outpatient or inpatient treatment.

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 for 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 1 aims is to identify the (neuro-) psychological patterns of suicidal attempters by comparing between the following four different groups:

1\) patients with a prior suicide attempt (SUAT) 2) patients with no prior suicide attempt, but suicidal ideation (SUID) 3) a general patient group (CLIN), and 4) a healthy control group (HLTH).

Project 2 aims to investigate how these patterns are modulated by the efficacious brief therapy ASSIP. In project 3, the feasibility, effects and cost-effectiveness of the ASSIP Home Treatment will be investigated.

Study design of project 2:

A longitudinal analysis over 12 months will only be conducted for the SUAT group. SUAT who participated in project 1 will be asked whether they also wish to participate in project 2. If they agree, they will be randomly assigned to either the intervention group ASSIP or STAR group to understand the influence of the brief ASSIP on (neuro-) psychological correlates in suicide attempters. The brief therapy ASSIP and STAR will take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland). Participants in project 2 will be assessed at 4 weeks, and 12 months after the first assessment which was conducted within project 1 and participants will be assessed on several process factors after each ASSIP or STAR session.

Вмешательства

• Поведенческое Attempted Suicide Short Intervention Program (ASSIP)
  The Attempted Suicide Short Intervention Program (ASSIP) is a specific therapy for patients with a suicide attempt in their biography. The brief therapy ASSIP consists of three to four sessions of approximately 50 minutes each. Session 1: A narrative interview is conducted, in which the patient is asked to tell her\*his personal story which led to the suicidal crisis. The narrative is video-recorded. Session 2: Using video-playback of the recorded narrative, patient and therapist explore furth
• Поведенческое Standard of care plus resource interview group (STAR)
  The standard of care plus resource interview group (STAR) will be offered a clinical interview, a risk assessment, and a non-specific resource focused intervention over three face-to-face sessions. In this resource focused intervention, the patient is asked to name her\*his resources, describe them, and give examples.

Первичные конечные точки

• Differences in Inhibitory Control [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0).]
• Differences in Inhibitory Control [Срок оценки: The assessment takes place after the completion of the 3/4 ASSIP or STAR therapy sessions (t1), i.e. approximately 4 weeks after the baseline assessment.]
• Differences in Inhibitory Control [Срок оценки: The assessment takes place 12 months after the baseline assessment (t2).]

Вторичные конечные точки (7)

• Movement analyses [Срок оценки: The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.]
• Selective Attention and Interference Control [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).]
• General Sense of Self-Efficacy [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).]
• Locus of control [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).]
• Psychological Pain [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).]
• Suicidal ideation and behavior [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).]
• Suicidal ideation [Срок оценки: The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).]

Критерии участия

Inclusion Criteria for Project 2:

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 brief therapy
• Owns a smartphone

Exclusion Criteria for Project 2:

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

• Serious cognitive impairment
• Any psychotic disorder
• Any current medication, which substantially impairs the attention span, reaction, rate or any other relevant cognitive functions
• Inability to follow the procedures of the study (e.g., insufficient mastery of the German language, previous enrolment into the current study)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital of Psychiatry and Psychotherapy, University of Bern — Bern

Публикации

• Peter, C. and A. Tuch, Suizidgedanken und Suizidversuche in der Schweizer Bevölkerung. Obsan Bulletin. Vol. 7. 2019, Nêuchatel. 2019.
• Bostwick JM, Pabbati C, Geske JR, McKean AJ. Suicide Attempt as a Risk Factor for Completed Suicide: Even More Lethal Than We Knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-1100. doi: 10.1176/appi.ajp.2016.15070854. Epub 2016 Aug 13. PMID 27523496
• Ystgaard M, Arensman E, Hawton K, Madge N, van Heeringen K, Hewitt A, de Wilde EJ, De Leo D, Fekete S. Deliberate self-harm in adolescents: comparison between those who receive help following self-harm and those who do not. J Adolesc. 2009 Aug;32(4):875-91. doi: 10.1016/j.adolescence.2008.10.010. Epub 2008 Nov 22. PMID 19028399
• Klonsky ED, May A. Rethinking impulsivity in suicide. Suicide Life Threat Behav. 2010 Dec;40(6):612-9. doi: 10.1521/suli.2010.40.6.612. PMID 21198330
• May, A.M. and E.D. Klonsky, What distinguishes suicide attempters from suicide ideators? A meta-analysis of potential factors. Clinical Psychology: Science and Practice, 2016. 23(1): p. 5.
• Lizardi D, Stanley B. Treatment engagement: a neglected aspect in the psychiatric care of suicidal patients. Psychiatr Serv. 2010 Dec;61(12):1183-91. doi: 10.1176/ps.2010.61.12.1183. PMID 21123401
• Schiepek, G., Ressourcenorientierung und Ressourcendiagnostik in der Psychotherapie. 2003.
• Gysin-Maillart, A., ASSIP - Kurztherapie nach Suizidversuch. Attempted Sucide Short Intervention Program. 2. Aufl. ed. 2021, Bern: Hogrefe.

Идентификаторы

NCT: NCT06263712 · 2021-02504 (Project 2)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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