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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
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
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).
Time frame: 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).
Time frame: through study completion, an average of 6 months
Treatment adherence
Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.
Time frame: through study completion, an average of 6 months
Therapeutic competence
Will be assessed via qualitative analysis of supervision protocols.
Time frame: through study completion, an average of 6 months
Treatment feasibility
Will be assessed via semi-structured qualitative interviews.
Time frame: through study completion, an average of 6 months
Therapeutic alliance I
Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar \& Gaston, 1989) for patients and therapists.
Time frame: 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).
Time frame: Baseline, 3-, 6-, 9- and 12-months follow up
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Therapeutic process
Will be assessed via semi-structured qualitative interviews.
Time frame: 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.
Time frame: 3-, 6- 9- and 12-months follow-up