Death, Dignity, Emotional Stress, Psychological Distress
Conditions
Keywords
Dignity Therapy; Terminally ill patients; Demoralization; Spiritual Well-Being; Dignity-related Distress
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
Interventions
BEHAVIORALDignity Therapy
Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress
Sponsors
European University of Rome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Contacts
Primary ContactLuigi Lombardo, MD
Outcome results
None listed