Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Emotional Stress
- Sponsor
- European University of Rome
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 6 years ago
Overview
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
Investigators
Luca Iani
Associate Professor
European University of Rome
Eligibility Criteria
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
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.
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).
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 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.(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.(Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment))