Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

European University of Rome55 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Emotional Stress Psychological Distress Death Dignity

Interventions

Dignity TherapyBEHAVIORAL

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Sanità e Ricerca

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment).

Secondary Outcomes

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

Time frame: Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)

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)

Time frame: Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)

Central Contacts

Luigi Lombardo, MD

CONTACT

+396588991 luigi.lombardo@virgilio.it

Data from ClinicalTrials.gov

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