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Trial Title: Short-term Psychodynamic Psychotherapy in Serious Physical Illness

NCT ID: NCT05520281

Condition: Malignant Neoplasm
Carcinoma
Palliative Care

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
Advanced Cancer
Death anxiety
Demoralization
Existential distress
Mental disorders

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Pre-Post Design

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)
Description: A short-term psychodynamic therapy that focuses on the special inner and outer situation of patients with a serious physical illness, especially with regard to the importance of relationships in a limited lifetime.
Arm group label: Patients

Summary: Life-threatening physical illness may powerfully re-activate existential conflict. There is little evidence to date on the effectiveness of relationship-focused therapies in this patient group.The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.

Detailed description: Severely physically ill patients may experience existential distress symptoms including helplessness, hopelessness, death anxiety, perceived burdensomeness and a sense of pointlessness. The latter can significantly interfere with end-of-life care processes and outcomes (receipt of treatment according to preferences, expression of desire for hastened death). So far, empirically tested psychotherapeutic programs in advanced life-threatening illness have predominantly been ultra-short and applied supportive and resource-oriented techniques. Psychodynamic treatment allows to address clinically significant existential distress through its conceptualization from early relational life experiences. The aim of this study is to pilot a psychodynamic treatment for patients with advanced cancer and high psychological distress.The inverstigators will 1. analyse the feasibility of the treatment, and 2. investigate changes in process- and patient-relevant outcomes over the course of the treatment The inverstigators will conduct a single-group pre-post study with five assessment points in which 50 adult patients diagnosed with advanced cancer will receive a manualized psychodynamic short-term therapy. Target parameters are assessed by diagnostic interviews, focus interviews, self-assessment questionnaires as well as electronic patient records. For research objective b) the investigators will compare the intervention group with a matched comparison group of a longitudinal cohort sample (NCT04600206). Matching will be based on stress level, demographic, and medical parameters across the 5 assessment points.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 18 years and older - UICC stage IV solid tumor - Informed consent - Current physical condition that allows for at least 12 therapy sessions - Indication: Presence of a mental disorder with existential stress and limitations in coping capacity Exclusion Criteria: - Acute suicidality - Psychotic disorder (ICD-10: F2 diagnosis) - Substance dependence or abuse (ICD-10: F1 diagnosis) - Structural deficits that interfere with attending to regular appointments - Other psychotherapeutic treatment - Severe cognitive impairment - Severe physical impairment - Insufficient German to give informed consent and complete self-report questionnaires

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf

Address:
City: Düsseldorf
Zip: 40225
Country: Germany

Status: Recruiting

Facility:
Name: University Medical Center Hamburg Eppendorf, Department of Medical Psychology

Address:
City: Hamburg
Zip: 20246
Country: Germany

Status: Recruiting

Facility:
Name: Institute of Social Work, University of Kassel

Address:
City: Kassel
Zip: 34127
Country: Germany

Status: Active, not recruiting

Facility:
Name: Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg

Address:
City: Würzburg
Zip: 97080
Country: Germany

Status: Recruiting

Start date: September 15, 2022

Completion date: June 30, 2025

Lead sponsor:
Agency: Universitätsklinikum Hamburg-Eppendorf
Agency class: Other

Source: Universitätsklinikum Hamburg-Eppendorf

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05520281

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