Dignity Therapy for Patients With Early Dementia and Their Family

Study Overview
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Brief Summary
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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.

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

Conditions
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Dementia, Mild, Depressive Disorder

Intervention / Treatment
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* Behavioral: Dignity Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Dignity, Family