ORPHYS - Short-term Psychodynamic Psychotherapy in Serious Physical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Treatment feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Treatment feasibility
时间窗: through study completion, an average of 6 months
Will be assessed via semi-structured qualitative interviews.
Treatment adherence
时间窗: through study completion, an average of 6 months
Will be assessed via qualitative analysis of therapeutic session protocols and audio recordings.
Therapeutic competence
时间窗: 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)
时间窗: 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
时间窗: 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).
次要结局
- Therapeutic process(through study completion, an average of 6 months)
- Therapeutic alliance I(3-, 6- 9- and 12-months follow-up)
- Interpersonal problems(Baseline, 3-, 6-, 9- and 12-months follow up)
- Therapeutic alliance II(3-, 6- 9- and 12-months follow-up)