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

NCT05655390 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Suicide, Attempted
  • Functioning, Psychosocial
  • Cognition
  • Neuroimaging
  • Quality of Lifte

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.

Sponsors & Collaborators

  • Iria Grande

    lead OTHER

Principal Investigators

  • Iria Grande · IDIBAPS- Hospital Clinic de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2027-04-30
Completion
2027-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05655390 on ClinicalTrials.gov