Feasibility and Effectiveness of a Personalized Inpatient Program for Persistent Depressive Disorder

NCT ID: NCT03616665

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Persistent Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBASPersonalized

Within the psychotherapy CBASPersonalized, the original specific six interpersonal CBASP strategies are augmented with intrapersonal evidence-based strategies. According to the frequently diagnosed comorbid disorders of PDD the following modules have been added: a) treatment of anxiety disorders and treatment of traumatic experiences, b) regulating intensive emotions, c) coping with resistant problems like pain, and d) relapse prevention. In addition, therapists adjust their strategies and therapeutic relationship according to the impairment in personality functioning and maladaptive personality traits of the patient.

Group Type: OTHER

CBASPersonalized

Intervention Type: OTHER

In addition to CBASPersonalized patients will receive algorithm-based pharmacotherapy in compliance with current national and international guidelines for depression treatment and according to clinical expert supervision. Of note, the intake of the medication is documented and taken into account in the analyses.

After completion of the six-week inpatient treatment, patients will be offered the six-to-twelve-week blended-online-aftercare CBASPersonalized@home.

Patients are allowed to attend additional inpatient groups like creative and sports therapy. The participation in these groups is documented.

Interventions

CBASPersonalized

In addition to CBASPersonalized patients will receive algorithm-based pharmacotherapy in compliance with current national and international guidelines for depression treatment and according to clinical expert supervision. Of note, the intake of the medication is documented and taken into account in the analyses.

After completion of the six-week inpatient treatment, patients will be offered the six-to-twelve-week blended-online-aftercare CBASPersonalized@home.

Patients are allowed to attend additional inpatient groups like creative and sports therapy. The participation in these groups is documented.

Intervention Type: OTHER

Other Intervention Names

Drug

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schön Klinik Bad Arolsen

UNKNOWN

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva-Lotta Brakemeier, Prof. Dr.

Role: STUDY_CHAIR

University Greifswald and Philipps University Marburg

Jörg-Tobias Hof

Role: PRINCIPAL_INVESTIGATOR

Schön Klinik Bad Arolsen (study site)

Locations

Schoen Klinik Bad Arolsen

Bad Arolsen, Hesse, Germany

Site Status: RECRUITING

Philipps University Marburg, Faculty psychology, department clinical psychology

Marburg, Hesse, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Eva-Lotta Brakemeier, Prof. Dr.

Role: CONTACT

eva-lotta.brakemeier@uni-greifswald.de

+491711278600

Thomas Gärtner, Dr.

Role: CONTACT

tgaertner@schoen-klinik.de

+49 569162383099

Facility Contacts

Thomas Gaertner, Dr. med.

Role: primary

tgaertner@schoen-kliniken.de

+49 5691 6238-3099

Winfried Rief, Prof. Dr.

Role: primary

rief@staff.Uni-Marburg.DE

+49 6421 28-23657

Other Identifiers

2018_14k

Identifier Type: -

Identifier Source: org_study_id