RecruitingNot ApplicableNCT05655390

iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)

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)


Sponsor

Iria Grande

Enrollment

120 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria5

  • 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

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Interventions

BEHAVIORAL'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

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NCT05655390


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