Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Carcinoma Clinical Trial

— ORPHYS  

Official title:

ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520281
• Other study ID #: DKH70113404-2
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Sigrun Vehling, PD, PhD
• Phone: +4940741056805
• Email: s.vehling[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Malignant Neoplasm
• Neoplasms
• Palliative Care

Intervention

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.

Locations

Country	Name	City	State
Germany	Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf	Düsseldorf
Germany	University Medical Center Hamburg Eppendorf, Department of Medical Psychology	Hamburg
Germany	Institute of Social Work, University of Kassel	Kassel
Germany	Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	Treatment adherence	Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.	through study completion, an average of 6 months
Primary	Therapeutic competence	Will be assessed via qualitative analysis of supervision protocols.	through study completion, an average of 6 months
Primary	Treatment feasibility	Will be assessed via semi-structured qualitative interviews.	through study completion, an average of 6 months
Secondary	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
Secondary	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
Secondary	Therapeutic process	Will be assessed via semi-structured qualitative interviews.	through study completion, an average of 6 months
Secondary	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