An interventional study of 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' in Suicide, Attempted, Functioning, Psychosocial and Cognition, sponsored by Iria Grande. Recruiting at 4 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Iria Grande · Not applicable, Interventional, and Treatment
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:
265 studies on the registry are indexed under Suicide, Attempted; 88 are open to participants now.
This study's planned enrollment of 120 is close to the median of 128 across 208 interventional studies indexed under Suicide, Attempted.
Browse Suicide, Attempted studies →This is the only study on the registry with Iria Grande as lead sponsor.
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Exclusion Criteria:
(TAU)
Treatment As Usual + RECONCILE Psychological Intervention.
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.
Also known as: The original Spanish name: Programa Grupal De Recuperación Funcional En Depresión Y Prevención De Riesgo Suicida Basado En Regulación Emocional Y Valores, RECONCILE Psychological Intervention
Psychosocial functioning changes in Functioning Assessment Short Test (FAST).
SA+Dep receiving the RECONCILE Intervention will show a decrease in FAST scores, compared to those SA+Dep receiving TAU. Lower general scores on this scale indicate better psychosocial functioning.
Time frame: Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment)
Cognitive changes in executive functions, specifically in decision-making measured by the modified version of the Iowa Gambling Task (IGT) with functional Magnetic Resonance (fMRI).
SA+Dep receiving the RECONCILE Intervention will experience greater improvement in cognitive performance, particularly in decision-making compared to those SA+Dep receiving TAU. A proxy of decision-making ability is extracted by formulae: Decision making = nº of safe choices - nº of risky choices OR (C+D) - (A+B).
Time frame: Baseline; 12 months after intervention
Cognitive changes in executive functions, specifically in impulsivity measured by Stroop Test (Stroop).
SA+Dep receiving the RECONCILE Intervention will experience greater improvement in cognitive performance, particularly in inhibition compared to those SA+Dep receiving TAU. Inhibitory control will be assessed by measure of interference obtained through Stroop test. Higher scores here mean better inhibitory control, thus less impulsivity. Normative data are taken from the original version of Stroop Test and will be used to assess improvement based on the baseline visit (vs. performance 12-month follow-up).
Time frame: Baseline, 3 months after intervention (short assessment form); 12 months after intervention (full assessment).
Cognitive changes in executive functions, specifically in attention measured by Conners' Performance Test (CPT-III).
SA+Dep receiving the RECONCILE Intervention will experience greater improvement in cognitive performance, particularly in attention, compared to those SA+Dep receiving TAU. Measures used to assess inattention include omissions, commissions, Hit Reaction Time (RT), Detectability (d'), Hit RT Block Change and Hit RT Inter-Stimulus Intervals (ISI) Change by means of CPT-III. All measures taken together provide an index of inattention, which is based on T-scores. In this test, higher scores reflect greater impairment. Normative data has been published in CPT III and will be used to assess improvement based on the baseline visit (vs. performance 12-month follow-up).
Time frame: Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment).
Changes in self-reported quality of life by Quality of Life 5-Dimensions scale (EuroQoL-5D).
SA+Dep receiving the RECONCILE Intervention will show greater improvement in QoL compared to those SA+Dep receiving TAU considering baseline measures self-reported in comparison with the following visits. This scale comprises two subscales: First subscale measures quality of life using a descriptive system by dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression). The higher the score here, the worse the quality of life. Second subscale uses a visual analogue scale from 0 to 100 for self-reporting overall quality of life. Higher scores here reflect better quality of life. All items refer to the current day.
Time frame: Baseline, 3 months after intervention (short assessment form); 12 months after intervention (full assessment).
Clinical changes in suicidal behavior assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
SA+Dep receiving the RECONCILE Intervention will not show suicidal behavior measured by C-SSRS in the two follow-up visits after intervention with SPI compared to those SA+Dep receiving TAU.
Time frame: Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment).
Clinical changes in depressive symptomatology assessed by Patient Health Questionnaire (PHQ-9).
Patient Health Questionnaire (PHQ-9) measures frequence of depressive symptoms occurrence. Lower scores show less depressive-related symptomatology. PHQ-9 scores following intervention are expected to be lower than at baseline.
Time frame: Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment).
Clinical changes in anxious symptomatology assessed by Generalized Anxiety Disorder (GAD-7).
Generalized Anxiety Disorder (GAD-7) measures frequence of anxious symptoms occurrence. Lower scores show less anxiety-related symptomatology. GAD-7 scores following intervention are expected to be lower than at baseline.
Time frame: Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment).
Changes in activation of different areas of the prefrontal cortex measured by functional Magnetic Resonance Imagining (fMRI).
SA+Dep receiving the RECONCILE Intervention will show changes in different areas of the prefrontal cortex. Changes expected include resting and activation conditions. We expect to detect more activation in Prefrontal Cortex (PFC) areas such as the ventrolateral PFC (including the orbitofrontal cortex), the anterior cingulate gyrus, the dorsomedial PFC and the dorsolateral PFC in patients receiving psychological intervention (in comparison with their baseline performance in task-related fMRI). Other areas such as the amygdala and medial temporal cortex will also be explored. Additionally, alterations in white matter connections measures by Diffusion Weighted Imaging (DWI) and Diffusion Tensor Imagining (DTI) will be assessed at baseline and will be compared with 6-months follow up imaging acquisition. Moreover, possible anatomical changes in prefrontal cortex areas will be also assessed.
Time frame: Baseline; 12 months after intervention.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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