Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Psychological Distress Clinical Trial

Official title:

Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256239
• Other study ID #: 004/2016
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2020
• Source: European University of Rome
• Contact: Luigi Lombardo, MD
• Phone: +396588991
• Email: luigi.lombardo[@]virgilio.it
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Death
• Dignity
• Emotional Stress
• Psychological Distress
• Stress, Psychological

Intervention

Behavioral:
• Dignity Therapy
Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress

Locations

Country	Name	City	State
Italy	Fondazione Sanità e Ricerca	Roma

Sponsors (1)

Lead Sponsor	Collaborator
European University of Rome

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment).
Secondary	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.	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	Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)
Secondary	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.	Dignity-related Distress will be measured with the Patient Dignity Inventory (minimum value=25, maximum value=125, with higher scores indicating a worse outcome)	Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)