Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

Conditions
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Death, Emotional Stress, Psychological Distress, Dignity

Intervention / Treatment
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* Behavioral: Dignity Therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dignity Therapy Group<br>Dignity Therapy is a short-term psychotherapy aimed at improving patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress. Therapy sessions, lasting between 20 and 60 minutes, were offered at the patients' bedside and audiotaped, and were conducted by a trained psyco-oncologist. After each therapy session, the audiotaped interview data were transcribed verbatim by a different psycho-oncologist and edited and reshaped into a written narrative by an expert in DT over the course of the next two to three days. Once the editing process was completed, another session was held to allow the therapist to read the generativity document to the patient and to make any editorial changes the patient deemed necessary. The final version of the generativity document was given to the patient to bequeath it to individuals of their choosing | Behavioral: Dignity Therapy<br>* Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress<br>|
| No Intervention: Control Group (Standard Palliative Care)<br>Standard Palliative Care was performed by a multidisciplinary care team composed of a palliative doctor, a psycho-oncologist, a nurse, a physiotherapist, a healthcare assistant, a social assistant, a volunteer and a spiritual assistant, tailoring care to the needs of patients and their families. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dignity Therapy; Terminally ill patients; Demoralization; Spiritual Well-Being; Dignity-related Distress