Feasibility and Effectiveness of a Personalized Inpatient Program Tailored for Persistent Depressive Disorder With Childhood Maltreatment and Comorbidity: Personalized Cognitive Behavioral Analysis System of Psychotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Hamilton Rating Scale of Depression, 24-item version (HRSD-24)
研究概览
简要总结
The major objective of this study is to evaluate a new conceptualized personalized concept of Cognitive Behavioral Analysis System of Psychotherapy (CBASPersonalized) in the treatment of patients with persistent depressive disorder (PDD), childhood maltreatment and a high rate of comorbidity. Patients receive a two-phase-treatment-program (six-weeks inpatient-treatment and six-to-twelve-weeks blended-online-aftercare) in combination with standardized pharmacotherapy in a routine clinical inpatient setting. This study addresses the primary research question: Is an intensive six-week inpatient CBASPersonalized treatment feasible and effective in a clinical sample of PDD patients? In addition, moderator, process and long-term analyses will be conducted for differential insights.
详细描述
Background: Persistent depressive disorder (PDD) is a prevalent disabling disorder. Given its high degree of treatment-resistance (TR), comorbidity, and suicidality, this patient group constitutes a massive health problem. The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) was specifically developed for the outpatient treatment of PDD showing superiority to active control groups in some studies. However, non-remission and relapse rates of CBASP are relatively high, which might be caused by the fact that within the original CBASP-concept the frequent comorbid disorders are not sufficiently addressed. Thus, an optimized personalized short and intensive CBASP-concept (CBASPersonalized) was established including the interpersonal CBASP-strategies while adding evidence-based intrapersonal strategies being tailored to the specific comorbid problems. In this study, the investigators will evaluate the feasibility and effectiveness of CBASPersonalized. Patients will receive a six-week inpatient treatment followed by a six-to-twelve-week blended-online-aftercare (CBASPersonalized@home) in combination with standardized pharmacotherapy in a routine clinical inpatient setting.
Methods: In the proposed prospective, mono-site study, 100 PDD patients with childhood maltreatment will be included. The study addresses the primary research question: Is an intensive six-week inpatient CBASPersonalized treatment feasible and effective in a clinical sample of PDD patients? It is hypothesized that six weeks after admission, CBASPersonalized will evoke significant reduction in depressive symptomatology (according to the 24-item version of the Hamilton Rating Scale of Depression, HRSD). The feasibility (acceptance and subjective experience) is assessed on the basis of the dropout rate and a self-assessed questionnaire, which measures satisfaction with and subjective effectiveness of the specific treatment components.
In addition, moderator, process and long-term analyses will be conducted for differential insights. Primary and secondary outcome will be analyzed using analysis of covariance (ANCOVA) controlling for pre-treatment scores. Moderator and process analyses will be performed using multiple regression and linear mixed models.
As a specific secondary research question, we will examine the associations between childhood maltreatment (CM), depression severity, and potential psychological mechanisms of this associations (emotion regulation, self-compassion, empathic distress, interpersonal problems) at the beginning of treatment. In addition, we will explore which changes in the potential psychological mechanisms are particularly closely related to changes in depressive symptoms.
As another additional research question, we will examine the associations between the state-like therapeutic alliance, trait-like alliance, and depression severity. We want to explore these associations as a possible effect mechanism and specify a possible transfer to CBASP specific mechanisms of actions.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of persistent depressive disorder (PDD) according to DSM-5
- •Experiences of childhood maltreatment (>Cut-off criteria in one of 5 scales of the Childhood Trauma Screener (CTS))
- •Sufficient German language skills
- •Have read and signed an informed consent form
排除标准
- •Life-time diagnosis of an schizophrenia or schizophrenic spectrum disorder according to DSM-5
- •Life-time diagnosis of a schizoid, schizotypal or antisocial personality disorder according to DSM-5
- •Consumption of legal (e.g. alcohol) or illegal substances during the inpatient stay
结局指标
主要结局
Hamilton Rating Scale of Depression, 24-item version (HRSD-24)
时间窗: The primary outcome is given by the post value (week six: end of inpatient treatment) in the HRSD24.
The change in HDRS-24 item score (Hamilton, 1960; Williams, 1988) from baseline to 6 weeks after study start will be the primary endpoint. The HRSD-24 is a semi-structured interview which is used to measure the severity of all symptom domains of depression as described by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) over a period of the last 7 days. It shows good psychometric properties. The HRSD-24 will be conducted by blind study raters at every time point. Raters evaluate symptom severity on a scale from 0 to 2 or 0 - 3 or 0 - 4 for each item, with higher number indicating higher symptom severity. The total score ranges from 0 to 75 with higher values indicating higher depression severity.
次要结局
- Beck Depression Inventory-II (BDI-II)(Baseline, 2, 4, 6, 8, 9, 14, and 37 weeks after study start)
- Social Support Questionnaire F-SozU(Baseline, 6, 14, and 37 weeks after study start)
- Montgomery Asberg Depression Rating Scale (MADRS)(Baseline, 2, 4, 6, 14, and 37 weeks after study start)
- Patient Health Questionnaire (PHQ)(Baseline, 6, 14, and 37 weeks after study start)
- Impact Message Inventory (IMI-R)(Baseline, 6, 14, and 37 weeks after study start)
- Measure of Disorders of Capacity as defined by the International Classification of Functioning (MINI-ICF)(Baseline, 6, 14, and 37 weeks after study start)
- Euthymia Scale (ES)(Baseline, 6, 14, and 37 weeks after study start)
- Evaluation of CBASPersonalized inpatient treatment(At the end of the inpatient treatment, 6 weeks after study start)
- Brief Symptom Inventory (BSI)(Baseline, 6, 14, and 37 weeks after study start)
- Inventory of Personality Organization (IPO-16)(Baseline, 6, 14, and 37 weeks after study start)
- Depressive Expectations Scale (DES)(Baseline, 6, 14, and 37 weeks after study start)
- WAI-e (WAI-expected)(Assessed prior to the start of therapy at an initial assessment (T0).)
- revised Impact of Event Scale (IES-R)(Baseline, 6, 14, and 37 weeks after study start)
- Working Alliance Inventory (WAI-SR)(T0 for WAI-e; WAI-C and WAI-T at 1, 2, 3, 4, 5, 6; WAI-C at 13, and 37 weeks after study start)
- Global Assessment of Functioning (GAF)(Baseline, 6, 14, and 37 weeks after study start)
- PATHEV (Patient Therapy Expectation and Evaluation questionnaire)(The PATHEV is administered at an initial assessment (T0), prior to the start of therapy.)
- Difficulties in Emotion Regulation Scale (DERS)(Baseline, 6, 14, and 37 weeks after study start)
- revised Adult Attachment Scale (AAS-R)(Baseline, 6, 14, and 37 weeks after study start)
- Self-Compassion Scale-Short Form (SCS-SF)(Baseline, 6, 14, and 37 weeks after study start)
- Health-related quality of life (EQ-5D-5L)(Baseline, 6, 14, and 37 weeks after study start)
- Interpersonal Reactivity Index (IRI)(Baseline, 6, 14, and 37 weeks after study start)