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Completed

NCT Number: NCT03692988

Dignity Therapy for Patients With Early Dementia and Their Family

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.

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Key information

Conditions

Dementia, Mild Brain Diseases Central Nervous System Diseases Dementia Depressive Disorder Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mood Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurixh

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dignity therapy

Behavioral

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 outcomes

  1. Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia

    Time frame: 10 days post randomization

    Acceptance based on the participation and refusal rate and dropout rate.

  2. Overall satisfaction of patients and their relatives

    Time frame: 10 days post randomization

    Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.

Secondary outcomes

  1. Psychological distress

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Waid City Hospital, Zurich

Registry information

Official study title

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

Acronym: DTD

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 2, 2018
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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