Clinical trial NCT06263712: 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
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 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inhibitory Control
Self Efficacy
Suicide Ideation
Suicide, Attempted
Locus of Control
Process Factors
Movement Synchrony
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Differences in Inhibitory Control
timeFrame: The assessment takes place 1 day to 1 week after informed consent (t0).
measure: Differences in Inhibitory Control
timeFrame: 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.
measure: Differences in Inhibitory Control
timeFrame: The assessment takes place 12 months after the baseline assessment (t2).
Secondary outcomes:
measure: Movement analyses
timeFrame: The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
measure: Selective Attention and Interference Control
timeFrame: 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).
measure: General Sense of Self-Efficacy
timeFrame: 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).
measure: Locus of control
timeFrame: 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).
measure: Psychological Pain
timeFrame: 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).
measure: Suicidal ideation and behavior
timeFrame: 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).
measure: Suicidal ideation
timeFrame: 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).
Other outcomes:
measure: Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility
timeFrame: 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).
measure: Sociodemographic data
timeFrame: 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).
measure: Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders
timeFrame: The assessment takes place 1 day to 1 week after informed consent (t0).
measure: Depressive symptoms
timeFrame: 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).
measure: Loneliness
timeFrame: 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).
measure: Therapeutic Alliance
timeFrame: The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
measure: Therapeutic change
timeFrame: The assessment takes place after the third session of ASSIP or STAR (week 3).
measure: Therapeutic outcomes
timeFrame: The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
measure: Adherence and Competence
timeFrame: The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
measure: Physiologically Experienced Emotional Distress and Arousal
timeFrame: 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).
measure: Ecological Momentary Assesment
timeFrame: Always three days before and three days after each ASSIP/STAR therapy session. Starts approximately 1 week after the informed consent and finishes approximately 4 weeks after the informed consent.
measure: Attention and Concentration Abilities
timeFrame: 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).
measure: Dissociative Experience
timeFrame: 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).
measure: Motivational Incongruence
timeFrame: 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).
measure: Motivational Goals
timeFrame: The assessment takes place 1 day to 1 week after informed consent (t0).
measure: Suicide-Related Coping
timeFrame: 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).
measure: Alcohol Use Screening
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Psychiatry and Psychotherapy, University of Bern
Study officials:
affiliation: University of Bern, University Hospital of Psychiatry, Translational Research Center
name: Anja C. Gysin-Maillart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peter, C. and A. Tuch, Suizidgedanken und Suizidversuche in der Schweizer Bevölkerung. Obsan Bulletin. Vol. 7. 2019, Nêuchatel. 2019.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Schiepek, G., Ressourcenorientierung und Ressourcendiagnostik in der Psychotherapie. 2003.
citation: Gysin-Maillart, A., ASSIP - Kurztherapie nach Suizidversuch. Attempted Sucide Short Intervention Program. 2. Aufl. ed. 2021, Bern: Hogrefe.
citation: Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24.
citation: Nock MK, Hwang I, Sampson NA, Kessler RC. Mental disorders, comorbidity and suicidal behavior: results from the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Aug;15(8):868-76. doi: 10.1038/mp.2009.29. Epub 2009 Mar 31.
citation: Rath D, Hallensleben N, Glaesmer H, Spangenberg L, Strauss M, Kersting A, Teismann T, Forkmann T. [Implicit Associations with Death: First Validation of the German Version of the Suicide Implicit Association Test (Suicide IAT)]. Psychother Psychosom Med Psychol. 2018 Mar;68(3-4):109-117. doi: 10.1055/s-0043-105070. Epub 2017 Jun 29. German.
citation: Ramseyer F, Tschacher W. Nonverbal synchrony in psychotherapy: coordinated body movement reflects relationship quality and outcome. J Consult Clin Psychol. 2011 Jun;79(3):284-95. doi: 10.1037/a0023419.
citation: MacLeod CM, MacDonald PA. Interdimensional interference in the Stroop effect: uncovering the cognitive and neural anatomy of attention. Trends Cogn Sci. 2000 Oct 1;4(10):383-391. doi: 10.1016/s1364-6613(00)01530-8.
citation: Reitan, R.M. and D. Wolfson, Category Test and Trail Making Test as measures of frontal lobe functions. The Clinical Neuropsychologist, 1995. 9(1): p. 50-56.
citation: Schwarzer, R. and M. Jerusalem, Skala zur allgemeinen Selbstwirksamkeitserwartung. 1999, Berlin: Freie Universität Berlin. 2013.
citation: Kovaleva, A., et al., Eine Kurzskala zur Messung von Kontrollüberzeugung: Die Skala Internale-Externale-Kontrollüberzeugung-4 (IE-4). 2012.
citation: Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
citation: Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.
citation: Mee S, Bunney BG, Bunney WE, Hetrick W, Potkin SG, Reist C. Assessment of psychological pain in major depressive episodes. J Psychiatr Res. 2011 Nov;45(11):1504-10. doi: 10.1016/j.jpsychires.2011.06.011. Epub 2011 Aug 9.
citation: Hautzinger, M., et al., Beck-depressions-inventar (BDI). Bearbeitung der deutschen Ausgabe. Testhandbuch. Bern: Huber, 1994.
citation: Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
citation: Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.
citation: Willutzki, U., et al., Direkte Veränderungsmessung in der Psychotherapie. Zeitschrift für Klinische Psychologie und Psychotherapie, 2013.
citation: Hasler G, Klaghofer R, Buddeberg C. [The University of Rhode Island Change Assessment Scale (URICA)]. Psychother Psychosom Med Psychol. 2003 Sep-Oct;53(9-10):406-11. doi: 10.1055/s-2003-42172. German.
citation: Gysin-Maillart, Michel, Conner, Westrin and Ehnvall (in progress).
citation: Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.
citation: Klonsky, E.D. and A.M. May, The three-step theory (3ST): A new theory of suicide rooted in the
citation: Teismann T, et al., Skala Suizidales Erleben und Verhalten (SSEV). Diagnostica. 2021; 67(3): 115-125.
citation: Lutz W, Böhnke JR. Der