Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Not Applicable

• Conditions: Death; Dignity; Emotional Stress; Psychological Distress

• Registration Number: NCT04256239
• Lead Sponsor: European University of Rome

Brief 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

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2020-01-31
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Pre-test to Post-test and Follow-up in Spiritual Well-Being, which will be reported in the outcome measure results data table as means and standard deviations.	Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment).	Spiritual well-being will be measured with the FACIT-Sp (minimum value=0; maximum value=48, with higher scores indicating a better outcome), a questionnaire assessing faith, peace and meaning

Secondary Outcome Measures

Name	Time	Method
Change from Pre-test to Post-test and Follow-up in Demoralization, which will be reported in the outcome measure results data table as means and standard deviations.	Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)	Demoralization will be measured with the Demoralization Scale (minimum value=0, maximum value=32, with higher scores indicating a worse outcome), which assesses 1) Loss of Meaning and Purpose and 2) Distress and Coping Ability
Change from Pre-test to Post-test and Follow-up in Dignity-related Distress, which will be reported in the outcome measure results data table as means and standard deviations.	Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)	Dignity-related Distress will be measured with the Patient Dignity Inventory (minimum value=25, maximum value=125, with higher scores indicating a worse outcome)

Trial Locations

Locations (1)

Fondazione Sanità e Ricerca; 🇮🇹 Roma, Italy