Clinical trial NCT05520281: Short-term Psychodynamic Psychotherapy in Serious Physical Illness
Official title: ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Neoplasm
Carcinoma
Palliative Care
Keywords: Advanced Cancer
Death anxiety
Demoralization
Existential distress
Mental disorders
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-Post Design
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: up to 12-months follow-up
measure: Acceptance
timeFrame: through study completion, an average of 6 months
measure: Treatment adherence
timeFrame: through study completion, an average of 6 months
measure: Therapeutic competence
timeFrame: through study completion, an average of 6 months
measure: Treatment feasibility
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Therapeutic alliance I
timeFrame: 3-, 6- 9- and 12-months follow-up
measure: Interpersonal problems
timeFrame: Baseline, 3-, 6-, 9- and 12-months follow up
measure: Therapeutic process
timeFrame: through study completion, an average of 6 months
measure: Therapeutic alliance II
timeFrame: 3-, 6- 9- and 12-months follow-up
Other outcomes:
measure: Desire for hastened death
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Suicidal ideation
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Coping and Demoralisation
timeFrame: a) Baseline and 6-months follow-up, b) Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Prevalence of adjustment disorder
timeFrame: Baseline and 6-months follow-up
measure: Aggressiveness of care
timeFrame: 4 weeks prior to death
measure: Prevalence of affective and anxiety disorders
timeFrame: Baseline and 6-months follow-up
measure: Death Anxiety
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Perceived Relatedness
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: End-of-life preparation and adaption
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Dignity related distress
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Meaningfulness in life and crisis of meaning
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Quality of life at the end of life
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Coping resources
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
measure: Need for and utilisation of psychosocial support for existential distress
timeFrame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Locations:
city: Düsseldorf
country: Germany
facility: Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf
city: Hamburg
country: Germany
facility: University Medical Center Hamburg Eppendorf, Department of Medical Psychology
city: Kassel
country: Germany
facility: Institute of Social Work, University of Kassel
city: Würzburg
country: Germany
facility: Psychosomatics, Psychotherapy and Psychooncology, Medicine II, University of Würzburg
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Sigrun Vehling, PD, PhD
role: PRINCIPAL_INVESTIGATOR
References: