Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

NCT04256239 | Unknown DMC

• 1 other identifier: 004/2016
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Stress; Psychological Distress; Death; Dignity

Keywords

Dignity Therapy; Terminally ill patients; Demoralization; Spiritual Well-Being; Dignity-related Distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Dignity Therapy Group

EXPERIMENTAL

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

Control Group (Standard Palliative Care)

NO INTERVENTION

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.

Interventions

Dignity Therapy BEHAVIORAL

Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress

Dignity Therapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• psychotic illness,
• dementia and severe neurological impairment

Sponsors & Collaborators

• European University of Rome: lead

Study Sites (1)

Fondazione Sanità e Ricerca

Roma, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 32670169 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Death

Interventions

Dignity Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Luca Iani, PhD

  European University of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Lombardo, MD

CONTACT

+396588991; luigi.lombardo@virgilio.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 28, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after the study will be published
• Access Criteria: Through the depository Figshare

Locations

IT (1)