Safety Intervention for Improving Functioning in Suicidal Attempters
NCT ID: NCT05655390
Last Updated: 2022-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2023-01-31
2025-01-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment As Usual
(TAU)
No interventions assigned to this group
Intervention Group
Treatment As Usual + Safety Intervention Planning.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Having attempted suicide
* Provide written informed consent
* No claustrophobia/metallic objects/implants
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Principal Investigators
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Iria Grande
Role: PRINCIPAL_INVESTIGATOR
IDIBAPS- Hospital Clinic de Barcelona
Locations
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Hospital Clínic Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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References
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Roberto N, Vazquez M, Radua J, Pariente JC, Munoz-Moreno E, Laredo C, Bracco L, Fernandez T, Martin-Parra S, Martinez-Aran A, Sanchez-Moreno J, Saiz P, Ruiz-Veguilla M, Borras R, Toll A, Elices M, Brambilla P, Courtet P, Perez-Sola V, Vieta E, Grande I. Safety intervention for improving functioning in suicidal attempters (STRONG): A secondary prevention study. Study rationale and research protocol. Span J Psychiatry Ment Health. 2023 Aug 25:S2950-2853(23)00001-7. doi: 10.1016/j.sjpmh.2023.05.001. Online ahead of print.
Other Identifiers
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HCB2022_0659
Identifier Type: -
Identifier Source: org_study_id