NCT06098924

Brief Summary

The aim of the study is to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (happiness, depression).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 15, 2023

Last Update Submit

October 22, 2023

Conditions

Keywords

spiritualitydepressionhappinesspost-trauma growthlife meaning

Outcome Measures

Primary Outcomes (6)

  • The status of spirituality among HD patients

    Self-administrated questionnaire of Spiritual Health Scale short form was used to collect data. The score range is 24 to 120, and the higher score means higher spirituality.

    1 day

  • The status of life-meaning among HD patients

    Self-administrated questionnaire of Life Attitude Profile was used to collect data. The score range is 39 to 195, and the higher score means higher level of life-meaning.

    1 day

  • The status of post-trauma growth among HD patients

    Self-administrated questionnaire of Posttraumatic Growth Inventory was used to collect data. The score range is 0 to 105, and the higher score means higher level of post-trauma growth.

    1 day

  • The status of depression among HD patients

    Self-administrated questionnaire of Beck Depression Inventory-II was used to collect data. The score range is 0 to 63, and the higher score means higher level of depressive tendency.

    7 minutes

  • The status of happiness among HD patients

    Self-administrated questionnaire of Chinese Happiness Inventory was used to collect data. The score range is 0 to 30, and the higher score means higher level of happiness.

    1 day

  • The mediating effect of life of meaning and post-traumatic growth

    Using these scores form these scales (mention above) to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (including happiness, depression).

    1 day

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults with regularly hemodylysis

You may qualify if:

  • Patients who are over 20 years old
  • voluntarily participate in the study and sign the respondent consent form
  • have received routine hemodialysis treatment for more than three months
  • have clear consciousness and can communicate in Mandarin and Taiwanese.

You may not qualify if:

  • Patients whose medical records record a diagnosis of schizophrenia
  • patients are taking antidepressant drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan, N/A = Not Applicable, 333 03, Taiwan

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • yachu hsiao

    Chang Gung University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 25, 2023

Study Start

September 10, 2023

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations