NCT07824401

Brief Summary

Due to the aging global population, an increasing number of elderly people are spending their remaining years in long-term care facilities. Common physical and psychological challenges in older adults increase with aging, significantly increasing their vulnerability and dependency and diminishing their sense of self and dignity. Loss of dignity is one of the most common challenges faced by older adults and can lead to various psychological issues, such as shame, depression, increased physical and mental stress, and even suicidal thoughts and behaviors. Therefore, care services for the elderly should strive to maintain and enhance their dignity and mitigate the negative impacts of this loss of dignity. Dignity therapy can help elderly people understand themselves by clarifying the value and meaning of life, fostering a sense of dignity and meaning. By creating a permanent, written record of their thoughts and words, which can be shared with important family members and friends, it can improve communication and interaction with family and friends, enhance their sense of dignity, and foster a sense of being functional, contributing, and valuable. The overall purpose of this three-year study was to investigate the effectiveness, applicability, and feasibility of dignity therapy for elderly people in long-term care facilities. The effectiveness of dignity therapy was assessed using indicators related to dignity and depression. Regarding the applicability and feasibility of dignity therapy, the perspectives of residents in long-term care facilities (experimental group), family members who received written documentation, and healthcare professionals were surveyed. The costs associated with the dignity therapy process, including labor, time, and financial costs, were assessed. This study employed a randomized controlled experimental design and recruited residents aged 65 and older from long-term care facilities in southern Taiwan. The experimental group received dignity therapy, while the control group received institutional care. The effective sample size was calculated to be 54 participants, with a minimum of 27 participants in each group. The Patient Dignity Inventory (Mandarin Version, PDI-MV) and the Patient Health Questionnaire-9 (PHQ-9) were used to assess the effectiveness of dignity therapy in residents of long-term care facilities before intervention (T0), immediately after intervention (T1), at one month (T2), two months (T3), three months (T4), and six months (T5). An 18-item semi-structured interview questionnaire was used to survey residents of long-term care facilities (experimental group), 100 family members who received written documentation, and 50 healthcare professionals regarding their opinions on the applicability and feasibility of dignity therapy. The study also calculated the associated human, time, and financial costs. This study anticipates that dignity therapy can enhance the dignity of residents in long-term care facilities and is applicable and feasible for these individuals. The study aims to provide academic and practical communities with a better understanding of the psychological, social, and spiritual needs of residents in long-term care facilities, as well as a reference for developing evidence-based care policies related to dignity therapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Dec 2025Jul 2028

First Submitted

Initial submission to the registry

August 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 12, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

September 17, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

August 25, 2025

Last Update Submit

September 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient Dignity Inventory Mandarin Version (PDI-MV)

    The Patient Dignity Inventory Mandarin Version (PDI-MV) consists of 25 items with a total score ranging from 25 to 125, where higher scores indicate lower levels of dignity.

    Baseline (T0), Day 7 (T1), 1-month (T2), 2-month (T3), 3-month (T4), and 6-month (T5)

  • Patient Health Questionnaire-9 (PHQ-9)

    The Patient Health Questionnaire-9 (PHQ-9) consists of 9 items with a total score ranging from 0 to 27, where higher scores indicate greater severity of depression.

    Baseline (T0), Day 7 (T1), 1-month (T2), 2-month (T3), 3-month (T4), and 6-month (T5)

Study Arms (2)

dignity therapy

EXPERIMENTAL

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

Behavioral: dignity therapyBehavioral: long term care

Long-term care

PLACEBO COMPARATOR

Participants receive care in a long-term care facility. Long-term care refers to physical and daily care provided by caregivers and medical professionals through home services, day care centers, residential care centers, and family-based care. Care includes nursing care, assistance with toileting, bathing, dressing, oral hygiene, feeding, medication administration, turning over, back massage, simple passive limb range of motion, getting in and out of bed, exercise assistance, assistance with the use of assistive devices, activity planning, and related services.

Behavioral: dignity therapyBehavioral: long term care

Interventions

dignity therapyBEHAVIORAL

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

Long-term caredignity therapy
long term careBEHAVIORAL

Participants receive care in a long-term care facility. Long-term care refers to physical and daily care provided by caregivers and medical professionals through home services, day care centers, residential care centers, and family-based care. Care includes nursing care, assistance with toileting, bathing, dressing, oral hygiene, feeding, medication administration, turning over, back massage, simple passive limb range of motion, getting in and out of bed, exercise assistance, assistance with the use of assistive devices, activity planning, and related services.

Long-term caredignity therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Those who receive long-term care services in a long-term care institution;
  • Those aged 65 or above;
  • Those who can communicate in Mandarin or Taiwanese;
  • Those who are willing to participate in this research project and fill out the consent form after the purpose and process of the research are explained.

You may not qualify if:

  • Those diagnosed with dementia, delirium, disability, mental disorder, or other organic brain disease;
  • Those who are unconscious and incapable of acting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tatung Jianguo Community Day Care Center

Kaohsiung City, 801001, Taiwan

RECRUITING

MeSH Terms

Interventions

Dignity TherapyLong-Term Care

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 17, 2026

Study Start

December 12, 2025

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

September 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations