Dignity Therapy for Patients With Early Dementia and Their Family

Depressive Disorder Clinical Trial

— DTD  

Official title:

Dignity Therapy: a Brief Psychological and Existential Intervention for Patients With Early Dementia and Their Family. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692988
• Other study ID #: 2018-0109
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Developed by Harvey M. Chochinov in 2005, Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share. DT has shown to improve quality of life and a sense of dignity, as well as supporting relatives in the process of grievance. Featuring a gradual loss of memories of the past, decline of cognitive functions and awareness of self, dementia can be regarded as a life-limiting or life-changing illness, which is often accompanied by significant psychological stress. DT may help patients and their relatives reduce this stress. Yet, no studies have been conducted to determine the benefits of DT in patients with early stage dementia (ESD). This study investigates the feasibility and acceptance of DT by patients with (very) mild dementia (CDR: 0.5 - 1.5) and their relatives, as well as their overall satisfaction. This study further seeks to determine the effects of DT on sense of dignity, quality of life, dyadic coping, and levels of anxiety and depression in a randomized controlled design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed Informed Consent
• Diagnosis of very mild dementia
• older 18 years of age
• Study partner (life partner, relative, close friend) available

Exclusion Criteria:

• Unable to speak and read German
• Physical or cognitive incapacity to participate

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild
• Depressive Disorder

Intervention

Behavioral:
• Dignity Therapy
Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share.

Locations

Country	Name	City	State
Switzerland	University of Zurixh	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Waid City Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia	Acceptance based on the participation and refusal rate and dropout rate.	10 days post randomization
Primary	Overall satisfaction of patients and their relatives	Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.	10 days post randomization
Secondary	Psychological distress	as measured by the Distress Thermometer (DT), which measures psychological stress using a numerical rating scale from 0 (no) to 10 (max. stress) Anxiety and Depression, as measured by the Hospital Anxiety and Depression Scale (HADS).	10 days post randomization