Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

  • STATUS
    Recruiting
  • participants needed
    55
  • sponsor
    European University of Rome
Updated on 19 February 2024
dementia

Summary

We conducted a randomized, controlled trial of dignity therapy for terminally ill patients with the aim of reducing dignity-related distress and demoralization and improving spiritual well-being.

Description

Sample size assessment: A recent meta-analysis showed that dignity interventions reach on average effect sizes of -1.01 on emotional distress (Ho and Shin, 2014). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 26 participants to detect effect sizes of 1.01 and higher.

Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced.

Statistical analysis plan: We conducted a 2 (group) X 3 (time [pre-treatment vs. post-treatment vs follow-up]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables

Details
Condition Death, Psychological stress, Psychological Distress, Dignity
Age 100 years and younger
Treatment Dignity Therapy
Clinical Study IdentifierNCT04256239
SponsorEuropean University of Rome
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

age over 18
diagnosis of life-threatening disease with a prognosis of six months or less
no evidence of dementia (as determined by retrospective assessments)
the ability to read and speak Italian and provide written informed consent
the availability for six to seven research encounters over the period of three weeks

Exclusion Criteria

psychotic illness
dementia and severe neurological impairment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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