Chronic IllnessesNCT04441060
Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
A study testing Distress intervention (CBT & Mindfulness-based program) in people with Chronic Illnesses and Physical Disability, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Illnesses, Physical Disability
- What is being tested?
- Distress intervention (CBT & Mindfulness-based program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2019to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)
Who cannot join
- Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
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.
Read the 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.
- Conditions
- Chronic Illnesses, Physical Disability
- Being tested
- Distress intervention (CBT & Mindfulness-based program)
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress intervention (CBT & Mindfulness-based program)Other
Distress intervention is not fully developed yet, but we are working on the development of distress intervention based on CBT \& Mindfulness-based program.
| Study group | Role | What they receive |
|---|---|---|
| distress intervention subject group | Experimental | 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. Receives: Other: Distress intervention (CBT & Mindfulness-based program) |
| distress intervention control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: 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: 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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start29 Apr 2019
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pusan National University
- Responsible party
- Sponsor
- Investigators
- Bong-Jin Hahm, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441060
- Sponsor's protocol ID
- HL19C0039
- Status last verified
- May 2022
- First submitted
- 23 Apr 2020
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities
- ClinicalTrials.gov ID
- NCT04441060
- Acronym / sponsor ID
- HL19C0039
- Conditions
- Chronic Illnesses, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Pusan National University
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| distress intervention subject group | Experimental | Other: Distress intervention (CBT & Mindfulness-based program)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. |
| distress intervention control group | No intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)
Key exclusion criteria (1 listed)
- Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distress intervention (CBT & Mindfulness-based program)Distress intervention is not fully developed yet, but we are working on the development of distress intervention based on CBT \& Mindfulness-based program. | Other | distress intervention subject group |
Primary outcome
Quality of life: World Health Organization's quality of life instrument -short version (WHOQOL-BREF)
Time frame: 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.
Stress: Perceived Stress Scale (PSS-10)
Time frame: 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.
Resilience: Connor-Davidson Resilience Scale (CDRS)
Time frame: 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.
Self-esteem: Rosenberg Self-Esteem Scale
Time frame: 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.
Acceptance of disability: Acceptance of Disability Scale
Time frame: 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.
Social participation: Participation Scale
Time frame: 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.
Pain: Pain belief & Perception inventory (PBPI)
Time frame: 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.
Insomnia: Insomnia Severity Index (ISI)
Time frame: 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.
Fatigue: FACIT-Fatigue
Time frame: 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.
Depression, Anxiety: Hospital Anxiety and Depression Scale
Time frame: 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.
Attention: Digit Span Test
Time frame: 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.
Attention: Trail Making Test
Time frame: 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.
Attention: Stoop Color-Word Test
Time frame: 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.
Suicide risk : Korea-Suicide Risk Scale (the name can be changed later)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bong-Jin Hahm, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distress intervention (CBT & Mindfulness-based program) in people with Chronic Illnesses and Physical Disability, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life: World Health Organization's quality of life instrument -short version (WHOQOL-BREF) (time frame: baseline, within a week after the end of the full course of intervention, and 1 month later after the intervention is finished). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.