Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities

NCT04441060 | Completed DMC

• 1 other identifier: HL19C0039
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illnesses; Physical Disability

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Interventions

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.

distress intervention subject group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)

You may not qualify if:

• Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Pusan National University: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 16801, South Korea

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bong-Jin Hahm, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: June 22, 2020
• Study Start: April 29, 2019
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: January 9, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)