Dignity Therapy for Patients With Early Dementia and Their Family (DTD)
Primary Purpose
Dementia, Mild, Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dignity Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia, Mild focused on measuring Psychotherapy, Dignity, Family
Eligibility Criteria
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
Sites / Locations
- University of Zurixh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventiongroup
Waitinggroup
Arm Description
Dignity Therapy. Patients receive dignity-therapy-Intervention after randomization
Patients receive dignity-therapy-Intervention after a waiting time of 3 months post randomization
Outcomes
Primary Outcome Measures
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.
Overall satisfaction of patients and their relatives
Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03692988
First Posted
September 27, 2018
Last Updated
June 14, 2021
Sponsor
University of Zurich
Collaborators
Waid City Hospital, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT03692988
Brief Title
Dignity Therapy for Patients With Early Dementia and Their Family
Acronym
DTD
Official Title
Dignity Therapy: a Brief Psychological and Existential Intervention for Patients With Early Dementia and Their Family. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Waid City Hospital, Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild, Depressive Disorder
Keywords
Psychotherapy, Dignity, Family
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventiongroup
Arm Type
Experimental
Arm Description
Dignity Therapy. Patients receive dignity-therapy-Intervention after randomization
Arm Title
Waitinggroup
Arm Type
No Intervention
Arm Description
Patients receive dignity-therapy-Intervention after a waiting time of 3 months post randomization
Intervention Type
Behavioral
Intervention Name(s)
Dignity Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia
Description
Acceptance based on the participation and refusal rate and dropout rate.
Time Frame
10 days post randomization
Title
Overall satisfaction of patients and their relatives
Description
Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.
Time Frame
10 days post randomization
Secondary Outcome Measure Information:
Title
Psychological distress
Description
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).
Time Frame
10 days post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Zurixh
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dignity Therapy for Patients With Early Dementia and Their Family
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