iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study)
NCT05655390, Not applicable, Recruiting, Iria Grande
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | iFD-SuRvivE funCtiONal effiCacy and bIologicaL corrElates (RECONCILE Study) | ClinicalTrials.gov |
| NCT number | NCT05655390 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Iria Grande | ClinicalTrials.gov |
| Conditions | Suicide, Attempted, Functioning, Psychosocial, Cognition, Neuroimaging, Quality of Lifte | ClinicalTrials.gov |
| Interventions | 'Functional Recovery in Depression and Suicide Risk Prevention Based on Emotion Regulation and Values: A Group Program' | ClinicalTrials.gov |
| First posted | 2022-12-19 | ClinicalTrials.gov |
| Last updated | 2026-05-12 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Psychosocial functioning changes in Functioning Assessment Short Test (FAST). | Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment) | 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. | ClinicalTrials.gov |
| Secondary | 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 | 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). | ClinicalTrials.gov |
| Secondary | 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). | 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). | ClinicalTrials.gov |
| Secondary | 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). | 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). | ClinicalTrials.gov |
| Secondary | 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). | 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. | ClinicalTrials.gov |
| Secondary | 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). | 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. | ClinicalTrials.gov |
| Secondary | Clinical changes in depressive symptomatology assessed by Patient Health Questionnaire (PHQ-9). | Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment). | 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. | ClinicalTrials.gov |
| Secondary | Clinical changes in anxious symptomatology assessed by Generalized Anxiety Disorder (GAD-7). | Baseline; 3 months after intervention (short assessment form); 12 months after intervention (full assessment). | 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. | ClinicalTrials.gov |
| Secondary | Changes in activation of different areas of the prefrontal cortex measured by functional Magnetic Resonance Imagining (fMRI). | Baseline; 12 months after intervention. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38591829 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)