DTD: Dignity Therapy for Patients With Early Dementia and Their Family

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT03692988

Collaborator

Waid City Hospital, Zurich (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dementia, Mild Depressive Disorder	Behavioral: Dignity Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia [10 days post randomization]
Acceptance based on the participation and refusal rate and dropout rate.
Overall satisfaction of patients and their relatives [10 days post randomization]
Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.

Secondary Outcome Measures

Psychological distress [10 days post randomization]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Zurixh	Zürich		Switzerland	8091

Sponsors and Collaborators

University of Zurich
Waid City Hospital, Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT03692988

Other Study ID Numbers:

2018-0109

First Posted:

Oct 2, 2018

Last Update Posted:

Jun 15, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Zurich

Psychotherapy

Dignity

Family

Additional relevant MeSH terms:

Dementia

Depressive Disorder

Study Results

No Results Posted as of Jun 15, 2021