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iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)
Sponsor: Iria Grande
Summary
The goal of this clinical trial is to assess the effectiveness of an original intervention 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' (from the original Spanish version: Programa Grupal De Recuperación Funcional En Depresión Y Prevención De Riesgo Suicida Basado En Regulación Emocional Y Valores) in depressed patients who have recently attempted suicide by improving their psychosocial functioning and therefore enhancing their ability to perform activities of daily living. As secondary objectives, the effectiveness of the intervention will be evaluated by determining cognitive performance (particularly decision-making, inhibition, and attention), quality of life, clinical status, and their relationship with neuroimaging correlates. Main target neuroimaging areas include the orbitofrontal cortex and dorsal prefrontal cortex.
Official title: The SURVIVE 2 Project: An Extended Cohort Study to Investigate Suicidal Behavior in Spain and the Efficacy of Secondary Prevention Strategies: iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-09-16
Completion Date
2027-10
Last Updated
2026-05-12
Healthy Volunteers
Yes
Interventions
'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program'
The RECONCILE psychological intervention, a structured telematic group program integrating components mainly from ACT, but also CBT, DBT, psychoeducation, and the collaborative construction of the Safety Planning Intervention (SPI). The aim of this therapy is to help individuals acquire strategies to regulate emotions, improve decision-making and daily functioning, and reduce the risk of suicidal behavior. The SPI will be conducted by identifying warning signs and providing each individual with personalized coping strategies and sources of support. Main skills to be acquired and integrated for the individual are: 1) SPI by six steps (identification of warning signs; applying internal coping strategies; use of social contacts as distraction; contacting family or significant others; contacting professionals and emergency services; making the environment safer), 2) Mindfulness, 3) Distress tolerance, 4) Emotional regulation, and 5) Values-based decision-making and behavioral activation.
Locations (4)
Hospital Clínic Barcelona
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain