iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIria Grande
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age over 18 years old
Having attempted suicide
Provide written informed consent
No claustrophobia/metallic objects/implants
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program'
BehavioralThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Treatment As UsualNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment)Secondary outcomes
1
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 intervention2
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).3
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).4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Iria Grande
Lead sponsor
Hospital Clinic of Barcelona
Sponsor institution
Source ClinicalTrials.gov