NCT Number: NCT05520281
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Clinical Institute for Psychosomatic Medicine and Psychotherapy, University Medical Center Düsseldorf, Düsseldorf, Germany
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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).
Time frame: through study completion, an average of 6 months
Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.
Time frame: through study completion, an average of 6 months
Will be assessed via qualitative analysis of supervision protocols.
Time frame: through study completion, an average of 6 months
Will be assessed via semi-structured qualitative interviews.
Time frame: 3-, 6- 9- and 12-months follow-up
Will be assessed via California Psychotherapy Alliance Scales (CALPAS, Marmar & Gaston, 1989) for patients and therapists.
Time frame: 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).
Time frame: through study completion, an average of 6 months
Will be assessed via semi-structured qualitative interviews.
Time frame: 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.
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the short form of the Schedule of Attitudes Toward Hastened Death (SAHD-A, Kolva et al., 2017).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the Beck Scale for Suicidal Ideation (BSS, Kliem & Brähler, 2015).
Time frame: a) Baseline and 6-months follow-up, b) Baseline, 3-, 6-, 9- and 12-months-follow-up
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).
Time frame: Baseline and 6-months follow-up
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).
Time frame: 4 weeks prior to death
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.
Time frame: Baseline and 6-months follow-up
Will be assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5, Beesdo-Baum et al., 2019).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the Death Anxiety and Distress Scale (DADDS, Krause etal., 2015).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using Subscales (Dependence, Relatedness) of the Depressive Experience Questionnaire (DEQ, Blatt, D'Afflitti & Quinlan, 1976; Blatt et al., 1982).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the Revised Loss Orientation and Life Engagement in Advanced Cancer Scale (LOLES, Vehling et al., 2018).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the Sense of Dignity Item (SDI, Chochinov et al., 2002) and the Patient Dignity Inventory (PDI, Chochinov, 2008).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the Sources of Meaning and Meaning in Life Questionnaire (SoMe, Schnell, 2009).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using a subscale (Life completion) of the Quality of Life at the End of Life-Cancer-Psychosocial Questionnaire (Qual-EC-P).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using subscales (coping competence, adaptability) of the questionnaire for patient competence in coping with cancer (PCQ, Aderhold et al., 2019).
Time frame: Baseline, 3-, 6-, 9- and 12-months-follow-up
Will be assessed using the Structured questionnaire of psychosocial support needs for existential distress.
Universitätsklinikum Hamburg-Eppendorf
Other
ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness
Acronym: ORPHYS
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