Clinical trial NCT04256239: Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial
Official title: Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Stress
Psychological Distress
Death
Dignity
Keywords: Dignity Therapy; Terminally ill patients; Demoralization; Spiritual Well-Being; Dignity-related Distress
Lead sponsor: European University of Rome
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: 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.
timeFrame: Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)
measure: 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.
timeFrame: Pre-test (before the intervention), Post-test (7-10 days after the baseline assessment), Follow-up (15-20 days after the baseline assessment)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Sanità e Ricerca
Study officials:
affiliation: European University of Rome
name: Luca Iani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iani L, De Vincenzo F, Maruelli A, Chochinov HM, Ragghianti M, Durante S, Lombardo L. Dignity Therapy Helps Terminally Ill Patients Maintain a Sense of Peace: Early Results of a Randomized Controlled Trial. Front Psychol. 2020 Jun 25;11:1468. doi: 10.3389/fpsyg.2020.01468. eCollection 2020.