Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
NCT04441060, Not applicable, Completed, Seoul National University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities | ClinicalTrials.gov |
| NCT number | NCT04441060 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 15 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Seoul National University Hospital | ClinicalTrials.gov |
| Conditions | Chronic Illnesses, Physical Disability | ClinicalTrials.gov |
| Interventions | Distress intervention (CBT & Mindfulness-based program) | ClinicalTrials.gov |
| First posted | 2020-06-22 | ClinicalTrials.gov |
| Last updated | 2024-01-09 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Quality of life: World Health Organization's quality of life instrument -short version (WHOQOL-BREF) | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Quality of life was assessed three times using the World Health Organization's quality of life instrument - short version (WHOQOL-BREF); before and after the intervention, and 1 month later after the intervention is finished. The amount of quality of life change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Stress: Perceived Stress Scale (PSS-10) | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Stress was assessed three times using Perceived Stress Scale (PSS-10); before and after the intervention, and 1 month later after the intervention is finished. The amount of Stress change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Resilience: Connor-Davidson Resilience Scale (CDRS) | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Resilience was assessed three times using Connor-Davidson Resilience Scale (CDRS); before and after the intervention, and 1 month later after the intervention is finished. The amount of resilience change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Self-esteem: Rosenberg Self-Esteem Scale | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Self-esteem was assessed three times using Rosenberg Self-Esteem Scale; before and after the intervention, and 1 month later after the intervention is finished. The amount of Self-esteem change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Acceptance of disability: Acceptance of Disability Scale | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Acceptance of disability was assessed three times using Acceptance of Disability Scale; before and after the intervention, and 1 month later after the intervention is finished. The amount of acceptance of disability change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Social participation: Participation Scale | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Social participation was assessed three times using Participation Scale; before and after the intervention, and 1 month later after the intervention is finished. The amount of Social participation change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Pain: Pain belief & Perception inventory (PBPI) | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Pain was assessed three times using Pain belief \& Perception inventory (PBPI); before and after the intervention, and 1 month later after the intervention is finished. The amount of pain change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Insomnia: Insomnia Severity Index (ISI) | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Insomnia was assessed three times using Insomnia Severity Index (ISI); before and after the intervention, and 1 month later after the intervention is finished. The amount of Insomnia change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Fatigue: FACIT-Fatigue | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Fatigue was assessed three times using FACIT-Fatigue; before and after the intervention, and 1 month later after the intervention is finished. The amount of fatigue change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Depression, Anxiety: Hospital Anxiety and Depression Scale | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Depression and anxiety was assessed three times using Hospital Anxiety and Depression Scale; before and after the intervention, and 1 month later after the intervention is finished. The amount of depression and anxiety change will be one of the primary outcomes. The 14-item Hospital Anxiety and Depression Scale comprises two subscales assessing anxiety and depression. Participants were asked to rate each item on a 4- point Likert scale (0-3); subscale scores ranged from 0 to 21. A cutoff score of 8 was applied to define clinical level of anxiety and depression. | ClinicalTrials.gov |
| Primary | Attention: Digit Span Test | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Attention was assessed three times using the Digit Span Test; before and after the intervention, and 1 month later after the intervention is finished. The Digit Span test is a neuropsychological test in most common use for measuring attention-concentration and working memory. The amount of Digit Span Test result (percentile score) change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Attention: Trail Making Test | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Attention was assessed three times using the Trail Making Test; before and after the intervention, and 1 month later after the intervention is finished. The Trail Making Test is a widely used neuropsychological measure that is known as a test of psychomotor speed, attention, sequencing, mental flexibility. The amount of Trail Making Test result (time to complete test) change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Attention: Stoop Color-Word Test | baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished | Attention was assessed three times using the Stoop Color-Word Test; before and after the intervention, and 1 month later after the intervention is finished. The Stroop color word test is useful to examines the frontal lobe function of selective attention and inhibition. The amount of Stoop Color-Word Test results (Time taken to perform, number performed correctly, number of errors) change will be one of the primary outcomes. | ClinicalTrials.gov |
| Primary | Suicide risk : Korea-Suicide Risk Scale (the name can be changed later) | through study completion, an average of 1 year | Suicide risk scale will be developed and compared with other known tools. The scale has no definite name yet, but it can be called as Korea-Suicide Risk Scale for now. A score will be reported on a scale, the higher score, the severe the suicidal risk. About 90 questions are developed for the scale, and out of them, meaningful questions will be selected through large-scale interview \& comparison with other scales about suicide during the study. We are not sure how many questions are selected by now, so the minimum or maximum score cannot be decided so far. Though, the questions have 4 point scale from 0 to 3. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 4
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 |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary 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)