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

ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma; Palliative Care; Malignant Neoplasm
• Intervention / Treatment: Behavioral: Short-term psychodynamic psychotherapy for patients with serious physical illness (ORPHYS)

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg Eppendorf, Department of Medical Psychology
  • Kassel, Germany, 34127
    • Institute of Social Work, University of Kassel
  • Würzburg, Germany, 97080
    • Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Will be assessed via Inventory for the Balanced Assessment of Negative Effects of Psychotherapy (INEP, Ladwig, Rief & Nestoriuc, 2014).	up to 12-months follow-up
Acceptance	Will be assessed via drop-out rates (number of patients not completing at least 12 sessions) and treatment compliance (number of sessions missed).	through study completion, an average of 6 months
Treatment adherence	Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.	through study completion, an average of 6 months
Therapeutic competence	Will be assessed via qualitative analysis of supervision protocols.	through study completion, an average of 6 months
Treatment feasibility	Will be assessed via semi-structured qualitative interviews.	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic alliance I	Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar & Gaston, 1989) for patients and therapists.	3-, 6- 9- and 12-months follow-up
Interpersonal problems	Will be assessed via inventory for assessment of interpersonal problems (IIP-D-32, Thomas, Brähler & Strauß, 2011).	Baseline, 3-, 6-, 9- and 12-months follow up
Therapeutic process	Will be assessed via semi-structured qualitative interviews.	through study completion, an average of 6 months
Therapeutic alliance II	Will be assessed via Helping Alliance Questionnaire (HAQ, Luborsky et al., 1996) (IIP-D-32, Thomas, Brähler & Strauß, 2011) for patients and therapists.	3-, 6- 9- and 12-months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desire for hastened death	Will be assessed using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Suicidal ideation	Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem & Brähler, 2015).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Coping and Demoralisation	Will be assessed using the a) Structured Interview for Psychological Adjustment and Demoralisation (Bobevski & Kissane, 2019) and b) Demoralisation Scale-II (DS-II, Robinson et al., 2016).	a) Baseline and 6-months follow-up, b) Baseline, 3-, 6-, 9- and 12-months-follow-up
Prevalence of adjustment disorder	Will be assessed according to International Classification of Diseases (ICD-11) using the Adjustment Disorder Module of the CIDI (Composite International Diagnostic Interview, (Perkonigg et al., 2018).	Baseline and 6-months follow-up
Aggressiveness of care	Will be assessed according to the criteria by Earle et al., 2003: receipt of chemotherapy in the last two weeks of life, emergency hospital admissions or intensive-care treatment during the last month of life. Will be obtained from medical chart reviews for deceased patients.	4 weeks prior to death
Prevalence of affective and anxiety disorders	Will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).	Baseline and 6-months follow-up
Death Anxiety	Will be assessed using the Death Anxiety and Distress Scale (DADDS, Krause etal., 2015).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Perceived Relatedness	Will be assessed using Subscales (Dependence, Relatedness) of the Depressive Experience Questionnaire (DEQ, Blatt, D'Afflitti & Quinlan, 1976; Blatt et al., 1982).	Baseline, 3-, 6-, 9- and 12-months-follow-up
End-of-life preparation and adaption	Will be assessed using the Revised Loss Orientation and Life Engagement in Advanced Cancer Scale (LOLES, Vehling et al., 2018).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Dignity related distress	Will be assessed using the Sense of Dignity Item (SDI, Chochinov et al., 2002) and the Patient Dignity Inventory (PDI, Chochinov, 2008).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Meaningfulness in life and crisis of meaning	Will be assessed using the Sources of Meaning and Meaning in Life Questionnaire (SoMe, Schnell, 2009).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Quality of life at the end of life	Will be assessed using a subscale (Life completion) of the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (Qual-EC-P).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Coping resources	Will be assessed using subscales (coping competence, adaptability) of the questionnaire for patient competence in coping with cancer (PCQ, Aderhold et al., 2019).	Baseline, 3-, 6-, 9- and 12-months-follow-up
Need for and utilisation of psychosocial support for existential distress	Will be assessed using the Structured questionnaire of psychosocial support needs for existential distress.	Baseline, 3-, 6-, 9- and 12-months-follow-up

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Sigrun Vehling, PD, PhD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): August 6, 2025
• Study Completion (Actual): August 6, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mental disorders; Advanced Cancer; Demoralization; Death anxiety; Existential distress
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma; Mental Disorders; Necrophobia
• Other Study ID Numbers: DKH70113404-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No