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Short-term Psychodynamic Psychotherapy in Serious Physical Illness (ORPHYS)

U

Universitätsklinikum Hamburg-Eppendorf

Status

Active, not recruiting

Conditions

Malignant Neoplasm
Carcinoma
Palliative Care

Treatments

Behavioral: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05520281
DKH70113404-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Patients
Experimental group
Description:
Adult patients across all phases of advanced disease (UICC stage IV solid tumor) from diagnosis to terminal stages
Treatment:
Behavioral: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)

Trial contacts and locations

4

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Central trial contact

Charlotte Walbaum, MSc; Sigrun Vehling, PD, PhD

Data sourced from clinicaltrials.gov

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