NCT03692988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

2.6 years

First QC Date

September 27, 2018

Last Update Submit

June 14, 2021

Conditions

Keywords

PsychotherapyDignityFamily

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Psychological distress

    10 days post randomization

Study Arms (2)

Interventiongroup

EXPERIMENTAL

Dignity Therapy. Patients receive dignity-therapy-Intervention after randomization

Behavioral: Dignity Therapy

Waitinggroup

NO INTERVENTION

Patients receive dignity-therapy-Intervention after a waiting time of 3 months post randomization

Interventions

Dignity TherapyBEHAVIORAL

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.

Interventiongroup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent
  • Diagnosis of very mild dementia
  • older 18 years of age
  • Study partner (life partner, relative, close friend) available

You may not qualify if:

  • Unable to speak and read German
  • Physical or cognitive incapacity to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurixh

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

DementiaLymphoma, FollicularDepressive Disorder

Interventions

Dignity Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMood Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 2, 2018

Study Start

October 1, 2018

Primary Completion

April 30, 2021

Study Completion

May 31, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations