Clinical trial NCT05655390: Safety Intervention for Improving Functioning in Suicidal Attempters
Official title: Safety Intervention for Improving Functioning in Suicidal Attempters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide, Attempted
Functioning, Psychosocial
Keywords: suicide
cognition
neuroimaging
psychosocial functioning
quality of life
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental randomized clinical study. Rater-blinded. Sample: Suicidal attempters.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effectiveness of a safety planning intervention in suicidal attempters by improving their psychosocial functional outcome and therefore enhancing their ability to perform the activities of daily living. As secondary objectives, assessment of the effectiveness of a safety planning intervention in suicidal attempters will be performed by determining cognitive performance (particularly decision-making, inhibition and attention), quality of life, clinical state and relating all these data with neuroimaging correlates. Target neuroimaging areas will be the orbitofrontal cortex and dorsal prefrontal cortex.

Detailed description: Design: STRONG is a single-centre experimental randomized clinical trial for suicidal attempters involving a safety planning intervention and 3- to 6-months follow-ups. This study will be carried out in the Bipolar and Depressive Disorders Unit, at Hospital Clínic de Barcelona. It will be rater-blinded and will include two parallel arms (1:1) in order to assess the efficacy of a safety planning intervention compared with treatment as usual. This project has been approved by the Ethical Committee of the Hospital Clinic of Barcelona and it will be carried up in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice in compliance with the data protection law in force and anonymization of the collected information.

Procedures: Subsequent to signing the informed consent, a complete baseline evaluation will be carried out which includes acquisition of socio-demographic and clinical variables, psychosocial functioning, cognitive performance, quality of life assessment and neuroimaging determinations (v0). Thereafter, the whole sample will be randomized in two groups of 60 participants by parallel assignment. A group of 60 people will exclusively receive treatment as usual (non-intervention group); whereas the other group of 60 participants will receive a safety planning intervention in addition to their treatment as usual (experimental group). After two months of finishing the intervention of 4 weeks (or three months after baseline), suicidal attempters will be reassessed from a socio-demographic, clinical, psychosocial functioning, quality of life assessment as well as brief neuropsychological evaluation (v1). The neuropsychological assessment in this point will be shorter to avoid learning effect. Five months after intervention (or 6-months after baseline), a completely socio-demographic, clinical psychosocial functioning, quality of life assessment as well as neuropsychological and neuroimaging evaluation will be carried out (v2).

Assessments:

A) Socio-demographic variables: Information on gender, age, marital status, current type of cohabitation, number of offspring (if any), educational level, years of education, employment status and socioeconomic status.

B) Clinical, psychosocial functioning, quality of life evaluation: Suicidal ideation and behaviour, clinical symptomatology, in general and depressive symptoms and anxiety symptoms in particular, lifetime history of psychiatric or medical comorbidities, diagnosis, number of hospitalizations, family history of affective and psychiatric disorders, and pharmacological treatment will be collected for all subjects, premorbid adjustment, psychosocial functioning, quality of life, impulsiveness, reflective functioning and stress associated with life events will be also assessed using standardized questionnaires. Clinical variables will be assessed at baseline, two months post-intervention and at the 6-month follow-up.

C) Neuropsychological assessment: Intelligence quotient, attention, processing speed, verbal and visual memory, working memory, and executive functions will be assessed in all subjects. The extended neuropsychological battery will be administered at baseline and at 6 months. To avoid learning effects, only some of the tests evaluating attention and executive functions will be administered in the 2-month assessment post-intervention.

D) Neuroimaging assessment: Magnetic resonance imaging (MRI) will be performed at baseline, and in the 6-month follow-up. Data acquisition will be performed using a full-body MRI scanner, a Siemens Magnetom Prisma 3 Teslas. A part from structural T1, resting-state functional MRI, and diffusion-weighted imaging, two tasks related to decision making and inhibition will be carried out. Non-contrast MRI will be used. Participants will not be exposed to radiation.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Having attempted suicide
* Provide written informed consent
* No claustrophobia/metallic objects/implants

Exclusion Criteria:

* Intelligence quotient below 70 and impaired functioning
* Any medical condition that could affect neuropsychological performance (such as neurological diseases) or a history of head trauma with loss of consciousness
* Participation in any structured psychological intervention within the past 6 months
* Patients who received electroconvulsive therapy within the past 6 months
* Inability to give inform consent

Primary outcomes:
measure: Psychosocial functioning changes in Functioning Assessment Short Test (FAST).
timeFrame: 2 months after intervention; 5 months after intervention
Secondary outcomes:
measure: Cognitive changes in executive functions, specifically in decision-making measured by Iowa Gambling Task (IGT).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Cognitive changes in executive functions, specifically in impulsivity measured by Stroop Test (Stroop).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Cognitive changes in executive functions, specifically in attention measured by Conners' Performance Test v.5 (CPT-II).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Changes in self-reported quality of life by Quality of Life 5-Dimensions scale (EuroQoL-5D).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Clinical changes in suicidal behavior assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Clinical changes in depressive symptomatology assessed by Patient Health Questionnaire (PHQ-9).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Clinical changes in anxious symptomatology assessed by Generalized Anxiety Disorder (GAD-7).
timeFrame: 2 months after intervention; 5 months after intervention
measure: Changes in activation of different areas of the prefrontal cortex measured by functional Magnetic Resonance Imagining (fMRI).
timeFrame: 5 months after intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
Study officials:
affiliation: IDIBAPS- Hospital Clinic de Barcelona
name: Iria Grande
role: PRINCIPAL_INVESTIGATOR
References: