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Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Recruiting
100 years and younger
All
Phase N/A

Overview

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

Eligibility

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

Study details
    Death
    Psychological stress
    Psychological Distress
    Dignity

NCT04256239

European University of Rome

16 February 2024

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