Dignity Therapy+: A Brief Psychological and Existential Intervention for Dying Patients and Their Families.

Not Applicable

Completed

• Conditions: Palliative Care
• Interventions: Behavioral: Dignity Therapy

• Registration Number: NCT02646527
• Lead Sponsor: University of Zurich

Brief Summary

Background: There has been significant progress in symptom management, pain relief and improvement of quality of life in patients nearing death by implementing palliative care programs. Existential and dignity related issues, such as loss of autonomy and sense of meaning or feeling a burden to others are frequent reasons for psychological distress and desire for hastened death. Dignity Therapy (DT), developed by Chochinov et al., is a brief, individualized psychotherapy for the purpose of relieving distress by directly addressing dignity conserving factors.

Aims: To test whether the inclusion of a patient's partner or designated family member into Dignity Therapy (DT+) could mitigate psychological distress (anxiety and depression) in both, the patient nearing the end of his life experiencing increased psychological distress and the patient's partner/family member compared to the control groups receiving Dignity Therapy in the single setting (DT) or standard palliative care (SPC).

Methods and design: In this randomized controlled trial a total of 159 patients with a diagnosis of an advanced disease and poor prognosis (life expectancy \< 6 months) who receive palliative care either in the Palliative Care Centre of the University Hospital Zurich (USZ) or the Clinic Susenberg, Zurich, or in the "Lighthouse" Hospice Zurich, will be randomly assigned to either DT+, DT, or SPC in a 1:1:1 ratio. Patients will be pre-screened and included if they report increased psychological distress (anxiety, depression using the Hospital Anxiety and Depression Scale=HADS). The therapy is guided by trained therapists and consists of 3 audiotaped sessions. The main focus of the intervention is to invite patients to reflect on their most important achievements, roles or other things in their lives or things that they would most want remembered. On completion, the audiorecording is transcribed and edited to provide a clear and readable narrative, the generativity document, which can be passed to a person of the patient's choice. DT+, in contrast to the original intervention developed by Chochinov et al., is a systemic approach in which patient's partners or designated family members are included.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Study Start: 2016-04
• Primary Completion: 2021-12
• Study Completion: 2022-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Informed Consent
• Diagnosis of advanced cancer and life expectancy < 6 months
• Receiving palliative care at the Palliative Care Centre or oncological wards at the University Hospital Zurich, the Susenberg Clinic, or Zurich 'Lighthouse' Hospice
• ≥ 18 years of age
• HADS score ≥ 8

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Exclusion Criteria

• Delirious (ICD-10: F05.9)
• Cognitively impaired
• Too ill to complete the requirements of the protocol
• Unable to speak and read German

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DT+	Dignity Therapy	Dignity Therapy is conducted with patients and partners
DT	Dignity Therapy	Dignity Therapy is conducted only with patients

Primary Outcome Measures

Name	Time	Method
The primary outcome will be psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS).	10 days	questionnaire score

Secondary Outcome Measures

Name	Time	Method
Health related quality of life (HRQol)	10 days	questionnaire score

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland