Functional Recovery Program for Depression and Suicide Risk (RECONCILE)
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)
This study tests a 12-week telehealth group program designed to help adults who recently attempted suicide and have depression improve daily functioning, emotion regulation, and cognitive control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Barcelona, Barcelona and 3 other locations) |
| Trial ID | NCT05655390 on ClinicalTrials.gov |
What this trial studies
RECONCILE is a multicenter, rater-blinded randomized trial in Spain that randomizes adults with recent suicide attempts to treatment-as-usual (TAU) or TAU plus a 12-week structured telematic group program. The group program delivers 12 weekly 90-minute sessions led by two trained therapists and combines Acceptance and Commitment Therapy with elements of CBT, DBT, psychoeducation, and an individualized safety plan. Outcomes include psychosocial functioning, cognition (decision-making, inhibition, attention), quality of life, clinical status, and neuroimaging correlates focused on the orbitofrontal and dorsal prefrontal cortices, with assessments at baseline, post-intervention, and 12-month follow-up. The study also enrolls comparison cohorts of depressed patients without recent attempts and healthy controls at one site to contextualize findings.
Who should consider this trial
Good fit: Adults over 18 with depression who have attempted suicide within the prior 10 days, can give informed consent, have no MRI contraindications, and have not received structured psychological interventions or ECT in the past 6 months are ideal candidates.
Not a fit: Patients with IQ below 70, major neurological conditions or recent head trauma, those unable to consent or participate in telematic group sessions, or those who received recent structured psychotherapy or ECT may not benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve patients' ability to perform daily activities and reduce ongoing suicide risk by strengthening emotion regulation and functional skills.
How similar studies have performed: Therapies that include ACT and DBT components have shown benefits for suicidal behavior and emotion regulation, but this particular combined telematic group program targeting early post-attempt functional recovery is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years old * Having attempted suicide * Provide written informed consent * No claustrophobia/metallic objects/implants Exclusion Criteria: * 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
Where this trial is running
Barcelona, Barcelona and 3 other locations
- Hospital Clínic Barcelona — Barcelona, Barcelona, Spain (Recruiting)
- Hospital del Mar — Barcelona, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Gregorio Marañón — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Iria Grande — IDIBAPS- Hospital Clinic de Barcelona
- Study coordinator: Iria Grande
- Email: igrande@clinic.cat
- Phone: +34932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.