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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