Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

European University of Rome

Status: Unknown

Conditions: Death; Dignity; Emotional Stress; Psychological Distress

Treatments: Behavioral: Dignity Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04256239

004/2016

Details and patient eligibility

About

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.

Full 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

Enrollment: 55 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Dignity Therapy Group

Experimental group

Description:

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

Treatment:

Behavioral: Dignity Therapy

Control Group (Standard Palliative Care)

No Intervention group

Description:

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.