NCT04256239

Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: European University of Rome · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Emotional Stress
• Psychological Distress
• Death
• Dignity

Interventions

Type	Name	Description
BEHAVIORAL	Dignity Therapy	Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress

Timeline

• Start date: 2018-02-28
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-02-05
• Last updated: 2020-02-05

Locations

1 site across 1 country: Italy