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

NCT ID: NCT04441060

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2022-07-30

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.

Conditions

Chronic Illnesses; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

distress intervention subject group

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.

Group Type: EXPERIMENTAL

Distress intervention (CBT & Mindfulness-based program)

Intervention Type: 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 control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bong-Jin Hahm, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HL19C0039

Identifier Type: -

Identifier Source: org_study_id