NCT05655390

Safety Intervention for Improving Functioning in Suicidal Attempters

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Suicide, Attempted
• Functioning, Psychosocial

Interventions

Type	Name	Description
BEHAVIORAL	Safety Intervention Planning	The therapy is based on the iFightDepression platform implemented by the European Alliance against Depression. The aim of this specific therapy is to help individuals to acquire strategies to regulate emotions and learn to tolerate discomfort preventing the imminent risk for suicidal behavior. The safety planning intervention will be conducted by identifying warning signs and provide each individual with personal and individualized coping strategies and sources of support. Main skills to be acquired and integrated for the individual are as it follows: 1) Contingency plan by five steps (identification of warning signs; applying internal coping strategies; network as distraction; safe environment; reasons for living and contact professionals), 2) Mindfulness, 3) Discomfort tolerance, and 4) Regulating emotions.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-02-01
• Completion: 2025-01-01
• First posted: 2022-12-19
• Last updated: 2022-12-19

Locations

1 site across 1 country: Spain