Safety Intervention for Improving Functioning in Suicidal Attempters
STRONG
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedDecember 19, 2022
October 1, 2022
1.1 years
October 25, 2022
December 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychosocial functioning changes in Functioning Assessment Short Test (FAST).
Suicidal attempters receiving a safety planning intervention will show a decrease in FAST scores, compared to those suicidal attempters receiving treatment as usual. Lower general scores on this scale indicate better psychosocial functioning.
2 months after intervention; 5 months after intervention
Secondary Outcomes (8)
Cognitive changes in executive functions, specifically in decision-making measured by Iowa Gambling Task (IGT).
2 months after intervention; 5 months after intervention
Cognitive changes in executive functions, specifically in impulsivity measured by Stroop Test (Stroop).
2 months after intervention; 5 months after intervention
Cognitive changes in executive functions, specifically in attention measured by Conners' Performance Test v.5 (CPT-II).
2 months after intervention; 5 months after intervention
Changes in self-reported quality of life by Quality of Life 5-Dimensions scale (EuroQoL-5D).
2 months after intervention; 5 months after intervention
Clinical changes in suicidal behavior assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
2 months after intervention; 5 months after intervention
- +3 more secondary outcomes
Study Arms (2)
Treatment As Usual
NO INTERVENTION(TAU)
Intervention Group
EXPERIMENTALTreatment As Usual + Safety Intervention Planning.
Interventions
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
You may qualify if:
- Age over 18 years old
- Having attempted suicide
- Provide written informed consent
- No claustrophobia/metallic objects/implants
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínic Barcelona
Barcelona, 08036, Spain
Related Publications (1)
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.
PMID: 38591829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iria Grande
IDIBAPS- Hospital Clinic de Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2022
First Posted
December 19, 2022
Study Start
January 1, 2023
Primary Completion
February 1, 2024
Study Completion
January 1, 2025
Last Updated
December 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- When approved by the PI. For a period of 6 months at maximum.
- Access Criteria
- Only coded data will be transferred to third parties and to other countries, which in no case will contain information that can directly identify the participant (such as name and surname, initials, address, social security number, etc.). In the event of such a transfer, it would be for the same purpose of the study described above and guaranteeing confidentiality.
Data will be shared only under a justified request. Names and personal data will never be displayed or shared with third parties. The data will be collected in an information file owned by the center. The research team undertakes to preserve the privacy of patients and the confidentiality of data, in accordance with the Organic Law 3/2018, 5th December, about Personal Data Protection. In case of transfer of data to third parties (external promoter to the center) these will be transferred in an encrypted system, eliminating any data that could identify the patient. Only the principal investigator and her team will have access to the list of patient identification codes.