Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
Primary Purpose
Chronic Illnesses, Physical Disability
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Distress intervention (CBT & Mindfulness-based program)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Illnesses
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)
Exclusion Criteria:
- Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
distress intervention subject group
distress intervention control group
Arm Description
Distress intervention program will be developed, and applied to the subject group, and they will be assessed before and after the intervention program with several tools.
No intervention will be applied to the control group. They will be assessed before and after the intervention program with same tools with subject group.
Outcomes
Primary Outcome Measures
Quality of life: World Health Organization's quality of life instrument -short version (WHOQOL-BREF)
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.
Stress: Perceived Stress Scale (PSS-10)
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.
Resilience: Connor-Davidson Resilience Scale (CDRS)
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.
Self-esteem: Rosenberg Self-Esteem Scale
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.
Acceptance of disability: Acceptance of Disability Scale
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.
Social participation: Participation Scale
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.
Pain: Pain belief & Perception inventory (PBPI)
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.
Insomnia: Insomnia Severity Index (ISI)
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.
Fatigue: FACIT-Fatigue
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.
Depression, Anxiety: Hospital Anxiety and Depression Scale
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.
Attention: Digit Span Test
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.
Attention: Trail Making Test
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.
Attention: Stoop Color-Word Test
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.
Suicide risk : Korea-Suicide Risk Scale (the name can be changed later)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04441060
First Posted
April 23, 2020
Last Updated
May 8, 2022
Sponsor
Seoul National University Hospital
Collaborators
Pusan National University
1. Study Identification
Unique Protocol Identification Number
NCT04441060
Brief Title
Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
Official Title
Development of a Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Pusan National University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities. To do these things, four times of interview & completion of self-report scale will be done, and newly developed distress intervention will be simulated to subject group and control group.
Detailed Description
The aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities.
To achieve the aims, multidisciplinary team is organized such as doctors of internal medicine, rehabilitative medicine, psychiatrist specialized in psychosomatics, psychologist, nurse, social worker and researchers.
Before developing the intervention and scale, review of literature about intervention, suicide, management system of chronic illness, several scales and others are done. Also, qualitative interview and self report scale with those patients are done to figure out what bothers them most, how they feel, and what kind of help they need.
Based on collected data, means of intervention is carefully selected and further review of literature is proceeded. Also, questions which describe patients' feeling, discomfort, and need are made. Moreover, modified management system of chronic illness is planned to develop to link between those who need help among patients and multidisciplinary team members.
Once, the intervention is developed, subject group and control group are recruited in stroke patients, and the intervention is simulated. The change of distress is measured before and after the intervention, and 1 month later the intervention is finished with several tools such as WHOQOL-BREF, Perceived Stress Scale, Rosenberg Self-Esteem Scale, Acceptance of Disability Scale, Participation Scale, Pain Belief & Perception Inventory, Insomnia Severity Index, FACIT-Fatigue, Hospital Anxiety and Depression Scale, digit span, trail making test, stroop test, verbal fluency test.
Also, newly developed questions and other scales are performed among patients to determine whether the newly developed questions are appropriate and how well they reflect their difficulties and feelings. After selecting the appropriate questions, the revised version will be tested by the patients twice in a different time frame.
If the revised version is appraised appropriate, it will be distributed as a cell phone application.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illnesses, Physical Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
570 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
distress intervention subject group
Arm Type
Experimental
Arm Description
Distress intervention program will be developed, and applied to the subject group, and they will be assessed before and after the intervention program with several tools.
Arm Title
distress intervention control group
Arm Type
No Intervention
Arm Description
No intervention will be applied to the control group. They will be assessed before and after the intervention program with same tools with subject group.
Intervention Type
Other
Intervention Name(s)
Distress intervention (CBT & Mindfulness-based program)
Intervention Description
Distress intervention is not fully developed yet, but we are working on the development of distress intervention based on CBT & Mindfulness-based program.
Primary Outcome Measure Information:
Title
Quality of life: World Health Organization's quality of life instrument -short version (WHOQOL-BREF)
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Stress: Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Resilience: Connor-Davidson Resilience Scale (CDRS)
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Self-esteem: Rosenberg Self-Esteem Scale
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Acceptance of disability: Acceptance of Disability Scale
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Social participation: Participation Scale
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Pain: Pain belief & Perception inventory (PBPI)
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Insomnia: Insomnia Severity Index (ISI)
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Fatigue: FACIT-Fatigue
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Depression, Anxiety: Hospital Anxiety and Depression Scale
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Attention: Digit Span Test
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Attention: Trail Making Test
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Attention: Stoop Color-Word Test
Description
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.
Time Frame
baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
Title
Suicide risk : Korea-Suicide Risk Scale (the name can be changed later)
Description
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.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)
Exclusion Criteria:
Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bong-Jin Hahm, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
16801
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
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