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

NCT05655390 | Recruiting DMC

• 1 other identifier: PI23/00822
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

suicide; cognition; neuroimaging; psychosocial functioning; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment)

Secondary Outcomes (8)

• 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).

  Baseline; 12 months after intervention

• Cognitive changes in executive functions, specifically in impulsivity measured by Stroop Test (Stroop).

  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).

  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).

  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).

  Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment).

Study Arms (2)

Treatment As Usual

NO INTERVENTION

(TAU)

Intervention Group

EXPERIMENTAL

Treatment As Usual + RECONCILE Psychological Intervention.

Behavioral: 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program'

Interventions

'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iria Grande: lead

Study Sites (4)

Hospital Clínic Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, Spain

RECRUITING

Related Publications (1)

• Roberto N, Vazquez M, Radua J, Pariente JC, Munoz-Moreno E, Laredo C, Bracco L, Fernandez T, Martin-Parra S, Martinez-Aran A, Sanchez-Moreno J, Saiz P, Ruiz-Veguilla M, Borras R, Toll A, Elices M, Brambilla P, Courtet P, Perez-Sola V, Vieta E, Grande I. Safety intervention for improving functioning in suicidal attempters (STRONG): A secondary prevention study. Study rationale and research protocol. Span J Psychiatry Ment Health. 2026 Jan-Mar;19(1):66-72. doi: 10.1016/j.sjpmh.2023.05.001. Epub 2023 Aug 25.

  PMID: 38591829 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicide

Interventions

Recovery of Function

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

• Iria Grande

  IDIBAPS- Hospital Clinic de Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iria Grande

CONTACT

+34932275400; igrande@clinic.cat

Natalia Roberto

CONTACT

+34932275400; roberto@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: Experimental randomized clinical study. Rater-blinded. Sample: Suicidal attempters.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: December 19, 2022
• Study Start: September 16, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When approved by the PI. For a period of 6 months at maximum.
• Access Criteria: Only coded data will be transferred to third parties and to other countries, which in no case will contain information that can directly identify the participant (such as name and surname, initials, address, social security number, etc.). In the event of such a transfer, it would be for the same purpose of the study described above and guaranteeing confidentiality.

Locations

ES (4)