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

Overview

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.

DESIGN: RECONCILE is a multicentre randomized rater-blinded clinical trial involving depressed patients who have attempted suicide within the previous 10 days. Participants will be recruited at four hospitals in Spain, two in Catalonia: Hospital Clínic de Barcelona and Hospital del Mar; and two in Madrid: Hospital Clínico San Carlos and Hospital Gregorio Marañón. Participants will be randomized (1:1) to receive treatment as usual (TAU) or the 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' and TAU. The study also includes two additional comparison groups recruited at Hospital Clínic de Barcelona: depressed patients without suicide attempts and healthy controls. INTERVENTION: The intervention period will last 12 weeks. It will include a baseline visit followed by assessments immediately after the intervention and at a 12-month follow-up. The 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' is a structured telematic group-based program consisting of 12 weekly sessions of approximately 90 minutes, delivered by two trained therapists. The intervention integrates evidence-based components from Acceptance and Commitment Therapy (ACT) mainly, but also Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), psychoeducation, and the creation of an individualised Safety Planning Intervention (SPI). The intervention is organized around three main therapeutic axes that are addressed transversally throughout the program: 1) Psychoeducation - Participants receive structured information about major depressive disorder and suicidal behavior, with the aim of improving illness awareness, identifying warning signs, reducing stigma, and promoting treatment adherence; 2) Therapeutic Skills Training - Participants are trained in psychological strategies to improve emotional regulation, behavioral activation, cognitive flexibility, coping with crises, mindfulness skills, values clarification, interpersonal functioning, and adaptive decision-making. These skills aim to reduce depressive symptomatology, enhance daily functioning, and prevent relapse of both depressive episodes and suicidal behavior; 3) Suicide Prevention through a Safety Plan Intervention - A personalized Safety Plan Intervention is collaboratively developed and continuously revised throughout the intervention as a central strategy for identifying warning signs, activating coping strategies, mobilizing support networks, and reducing the risk of future suicidal crises. The intervention promotes active participant involvement through experiential exercises, group discussion, and structured homework assignments designed to facilitate the application of therapeutic strategies in everyday life. Sessions follow a standardized structure including review of homework, introduction of theoretical-practical contents, experiential exercises, and assignment of between-session practice tasks. In addition, a complementary session involving a family member or significant other is offered (approximately after session four) in order to enhance social support, improve understanding of depressive symptoms and suicidal behavior, and facilitate implementation of the SPI outside the therapeutic context. PROCEDURES: After signing informed consent, participants will undergo a comprehensive baseline evaluation including sociodemographic and clinical variables, psychosocial functioning, quality of life assessment, neuropsychological performance and neuroimaging acquisition (V0). The intervention consists of 12 weekly supervised telematic group sessions. At the end of the intervention (V1), participants will undergo a brief neuropsychological and clinical reassessment. At 12 months after baseline (V2), participants will undergo a full reassessment including: clinical evaluation, psychosocial functioning, quality of life (QoL), neuropsychological battery, structural and functional MRI. 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, QoL: 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, QoL, impulsiveness, reflective functioning and stress associated with life events will be also assessed using standardized questionnaires. Clinical variables will be assessed at baseline, 3 months post-intervention and at the 12-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 12 months. To avoid learning effects, only some of the tests evaluating attention and executive functions will be administered in the 3-month assessment post-intervention. D) Neuroimaging assessment: Magnetic resonance imaging (MRI) will be performed at baseline, and in the 12-month follow-up. Data acquisition will be performed using a full-body MRI scanner, a Siemens Magnetom Prisma 3 Teslas. Apart from structural T1, resting-state functional MRI, and diffusion-weighted imaging, a task related to decision making (IGT modified version according to Lawrence et al 2009, DOI: 10.1093/cercor/bhn154) will be carried out. Non-contrast MRI will be used. Participants will not be exposed to radiation. CONDITIONS: There will be 3 groups of participants: (1) Depressed patients who have recently performed a suicide attempt (SA+Dep; n=120); (2) Depressed patients without prior suicide attempts (Dep; n=30); (3) Healthy Controls (HC; n=30). SA+Dep will be randomized into: * Experimental group: RECONCILE Intervention + TAU (n=60) * Control group: TAU only (n=60)