Short-term Psychodynamic Psychotherapy in Serious Physical Illness

Not Applicable

Active, not recruiting

• Conditions: Malignant Neoplasm; Carcinoma; Palliative Care

• Registration Number: NCT05520281
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Study Start: 2022-09-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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, Germany