Dignity Therapy for Patients With Early Dementia and Their Family

Not Applicable

Completed

• Conditions: Dementia, Mild; Depressive Disorder
• Interventions: Behavioral: Dignity Therapy

• Registration Number: NCT03692988
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-27
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventiongroup	Dignity Therapy	Dignity Therapy. Patients receive dignity-therapy-Intervention after randomization

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

University of Zurixh; 🇨🇭 Zürich, Switzerland