Persistent Depressive Disorder Clinical Trial
Official title:
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
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.
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.
Finally, the analyses of the outcomes at the end of the six-to-twelve week blended
online-aftercare and the follow-up survey 6 months after end of treatment will provide
important results on the blended after-care program as well as longterm treatment outcome. Of
note, we will evaluate the online continuation treatment CBASPersonalized@home regarding
feasibility. Therefore, patients' expectations towards the intervention, their adherence
(completed modules and exercises), acceptance and satisfaction with the intervention as well
as the perceived fit and perceived effectiveness and usability of the intervention will be
analyzed. Depression severity at the beginning of CBASPersonalized@home, expectations,
satisfaction and therapeutic alliance will be analyzed as possible predictors of adherence. A
possible relationship between changes in depressive symptoms in the course of the
continuation treatment and adherence will be explored.
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