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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04256239
Study type Interventional
Source European University of Rome
Contact Luigi Lombardo, MD
Phone +396588991
Email luigi.lombardo@virgilio.it
Status Recruiting
Phase N/A
Start date February 28, 2018
Completion date December 31, 2022

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