Dignity Therapy for Patients With Early Dementia and Their Family (DTD)

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Dementia, Mild
• Intervention / Treatment: Behavioral: Dignity Therapy

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • University of Zurixh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventiongroup; Dignity Therapy. Patients receive dignity-therapy-Intervention after randomization	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.
No Intervention: Waitinggroup; Patients receive dignity-therapy-Intervention after a waiting time of 3 months post randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Waid City Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Family; Psychotherapy; Dignity
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Neurocognitive Disorders; Depressive Disorder; Dementia
• Other Study ID Numbers: 2018-0109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No