Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Study Overview
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Brief Summary
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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
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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 analyse the feasibility of the treatment, and 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.

Official Title
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ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Conditions
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Malignant Neoplasm, Carcinoma, Palliative Care

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-Post Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Cancer, Death anxiety, Demoralization, Existential distress, Mental disorders