Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000410954
Ethics application status
Approved
Date submitted
19/04/2011
Date registered
20/04/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Dignity Therapy: A Psychotherapeutic Intervention to Enhance the End of Life Experience for Persons with Motor Neurone Disease and their Family Carers
Scientific title
A pilot study to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy for persons with motor neurone disease and their family carers
Secondary ID [1] 260038 0
Nil
Universal Trial Number (UTN)
U1111-1120-8584
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor Neurone Disease 265698 0
Amyotrophic Lateral Sclerosis 265699 0
Condition category
Condition code
Neurological 265835 265835 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dignity Therapy is a brief, individualized psychotherapeutic intervention where people with terminal illness are offered the opportunity to create a generativity document, the Dignity Therapy transcript. In a recorded face-to-face interview guided by a counsellor, the patient is invited to recount aspects of their life they want remembered, find meaning and purpose to their life, and express final words or advice to their family and friends. The interview is transcribed and edited, and a final document is returned to the patient to share with others as they wish. This short-term therapy can be delivered in two to four sessions of 45 minutes to an hour over the course of a week or two, depending on the patient's desires and health status.
Intervention code [1] 264457 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266593 0
Hopefulness in persons with MND, as measured by the Herth Hope Index
Timepoint [1] 266593 0
One week post treatment
Primary outcome [2] 266594 0
Perceived caregiver burden in MND family carers, as measured by the Zarit Burden Interview
Timepoint [2] 266594 0
One week post treatment
Secondary outcome [1] 276075 0
Spiritual wellbeing in persons with MND, as measured by the FACIT-sp
Timepoint [1] 276075 0
One week post treatment
Secondary outcome [2] 276076 0
Patient Dignity in persons with MND, as measured by the Patient Dignity Inventory
Timepoint [2] 276076 0
One week post treatment
Secondary outcome [3] 276077 0
Hopefulness in MND family carers, as measured by the Herth Hope Index
Timepoint [3] 276077 0
One week post treatment
Secondary outcome [4] 276078 0
Anxiety and depression in MND family carers, as measured by the Hospital Anxiety and Depression Scale
Timepoint [4] 276078 0
One week post treatment
Secondary outcome [5] 276079 0
Acceptability of Dignity Therapy to persons with MND and their family carers, as measured by the Dignity Therapy Feedback Questionairre.
Timepoint [5] 276079 0
One week post treatment

Eligibility
Key inclusion criteria
Persons diagnosed with MND/ALS able to provide informed consent and communicate in English. Family carers of persons diagnosed with MND who are accepted into the study and able to communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons unable to communicate in English and/or provide informed consent due to cognitive issues or illness severity

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2011
Actual
25/05/2011
Date of last participant enrolment
Anticipated
Actual
26/07/2013
Date of last data collection
Anticipated
Actual
21/08/2013
Sample size
Target
50
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 264926 0
Government body
Name [1] 264926 0
Australian Research Council
Country [1] 264926 0
Australia
Funding source category [2] 264927 0
Charities/Societies/Foundations
Name [2] 264927 0
Motor Neurone Disease Association of WA, Inc
Country [2] 264927 0
Australia
Primary sponsor type
University
Name
School of Psychology and Speech Pathology
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 264027 0
None
Name [1] 264027 0
Address [1] 264027 0
Country [1] 264027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266885 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 266885 0
c/o Office of Research and Development
Curtin University
GPO Box 1987U
Perth WA 6845
Ethics committee country [1] 266885 0
Australia
Date submitted for ethics approval [1] 266885 0
Approval date [1] 266885 0
06/04/2011
Ethics approval number [1] 266885 0
19/2011

Summary
Brief summary
Dignity Therapy, a brief psychotherapeutic intervention based on empirical research into the concept of dignity at the end of life, has proven successful at increasing hope, sense of meaning and will to live in a palliative care population where most patients had cancer diagnoses (Chochinov, Hack et al. 2005). This study will establish the feasibility and acceptability of offering Dignity Therapy to the MND patient population, and measure associations of the intervention with increased hope, meaning and dignity. It will lay the groundwork for a possible future experimental study.

This study will also examine what impact Dignity Therapy has on the MND family carer during the caring experience, specifically looking at whether Dignity Therapy with the patient is associated with an increase in hope or decrease in anxiety, depression and caregiver burden in the family carer. Previous Dignity Therapy studies focused on the intervention’s positive influence on the bereavement experience of family members, but did not look at how the intervention may affect the carer during the caring experience.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32519 0
Dr Brenda Bentley
Address 32519 0
Murdoch University, School of Health Professions
90 South Street, Murdoch, WA 6150
Country 32519 0
Australia
Phone 32519 0
+61427737712
Fax 32519 0
Email 32519 0
b,[email protected]
Contact person for public queries
Name 15766 0
Brenda Bentley
Address 15766 0
Murdoch University, School of Health Professions, 90 south Street, Murdoch WA 6150
Country 15766 0
Australia
Phone 15766 0
+61427737712
Fax 15766 0
Email 15766 0
[email protected]
Contact person for scientific queries
Name 6694 0
Brenda Bentley
Address 6694 0
Murdoch University, School of Health Professions, 90 south Street, Murdoch WA 6150
Country 6694 0
Australia
Phone 6694 0
+61427737712
Fax 6694 0
Email 6694 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIs dignity therapy feasible to enhance the end of life experience for people with motor neurone disease and their family carers?.2012https://dx.doi.org/10.1186/1472-684X-11-18
EmbaseFeasibility, acceptability and potential effectiveness of dignity therapy for family carers of people with motor neurone disease.2014https://dx.doi.org/10.1186/1472-684X-13-12
N.B. These documents automatically identified may not have been verified by the study sponsor.