Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial

NCT ID: NCT04256239

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2022-12-31

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

Conditions

Emotional Stress; Psychological Distress; Death; Dignity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dignity Therapy Group

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

Group Type: EXPERIMENTAL

Dignity Therapy

Intervention Type: BEHAVIORAL

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

Control Group (Standard Palliative Care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dignity Therapy

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

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European University of Rome

OTHER

Sponsor Role: lead

Responsible Party

Luca Iani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Iani, PhD

Role: PRINCIPAL_INVESTIGATOR

European University of Rome

Locations

Fondazione Sanità e Ricerca

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luigi Lombardo, MD

Role: CONTACT

luigi.lombardo@virgilio.it

+396588991

Facility Contacts

Luigi Lombardo, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32670169 (View on PubMed)

Other Identifiers

004/2016

Identifier Type: -

Identifier Source: org_study_id