Clinical trial NCT03616665: Feasibility and Effectiveness of a Personalized Inpatient Program for Persistent Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Depressive Disorder
Keywords: persistent depressive disorder
psychotherapy
cognitive behavioral therapy
inpatient treatment
childhood maltreatment
treatment-resistance
clinical effectiveness
personalized psychotherapy
comorbidity
cognitive behavioral analysis system of psychotherapy
online aftercare
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Schön Klinik Bad Arolsen
First posted: 2018-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In the proposed prospective, mono-site, evaluator-blinded study, 100 PDD patients will be included. The study addresses the primary research question: Is the six-week inpatient CBASPersonalized-treatment effective in PDD? It is hypothesized that six weeks after randomization, CBASPersonalized will evoke significant reduction in depressive symptomatology. In addition, feasibility will be examined and differential indication by moderator, process and long-term analyses will be investigated. A follow-up survey six months after end of treatment will provide important results on long-term treatment outcome.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Rating Scale of Depression, 24-item version (HRSD-24)
timeFrame: The primary outcome is given by the post value (week six: end of inpatient treatment) in the HRSD24.
Secondary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, 2, 4, 6, 8, 9, 14, and 37 weeks after study start
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, 2, 4, 6, 14, and 37 weeks after study start
measure: Brief Symptom Inventory (BSI)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Inventory of Personality Organization (IPO-16)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: revised Impact of Event Scale (IES-R)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Social Support Questionnaire F-SozU
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Depressive Expectations Scale (DES)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: revised Adult Attachment Scale (AAS-R)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Self-Compassion Scale-Short Form (SCS-SF)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Impact Message Inventory (IMI-R)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Measure of Disorders of Capacity as defined by the International Classification of Functioning (MINI-ICF)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Euthymia Scale (ES)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Working Alliance Inventory (WAI-SR)
timeFrame: 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
measure: Global Assessment of Functioning (GAF)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: PATHEV (Patient Therapy Expectation and Evaluation questionnaire)
timeFrame: The PATHEV is administered at an initial assessment (T0), prior to the start of therapy.
measure: WAI-e (WAI-expected)
timeFrame: Assessed prior to the start of therapy at an initial assessment (T0).
measure: Interpersonal Reactivity Index (IRI)
timeFrame: Baseline, 6, 14, and 37 weeks after study start
measure: Evaluation of CBASPersonalized inpatient treatment
timeFrame: At the end of the inpatient treatment, 6 weeks after study start
Other outcomes:
measure: Moderator variable: Childhood Trauma Questionnaire (CTQ-SF)
timeFrame: baseline
measure: Process variable: Inventory of Interpersonal Problems (IIP)
timeFrame: Baseline, 6, 14 and 37 weeks after study start
measure: General Self-Efficacy Scale (GSE; Jerusalem & Schwarzer, 1999)
timeFrame: Baseline, 6, 14 and 37 weeks after study start
measure: Videoconference and Telepresence Scale (VTS; Bouchard & Robillard, 2000)
timeFrame: 9 and 12 weeks after study start
measure: Session Evaluation Questionnaire (SEQ; Stiles & Snow, 1984)
timeFrame: 9 and 12 weeks after study start
measure: System Usability Scale (SUS; Brooke, 1986)
timeFrame: 9 and 12 weeks after study start
measure: Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I; Boß et al., 2016)
timeFrame: 9, 12 and 14 weeks after study start
measure: Working Alliance Inventory for guided Internet Interventions (WAI-I; Penedo et al., 2019)
timeFrame: 9, 12 and 14 weeks after study start
measure: Evaluation of CBASPersonalized@home online continuation treatment
timeFrame: At the end of the online continuation treatment, 14 weeks after study start
Locations:
city: Bad Arolsen
country: Germany
facility: Schoen Klinik Bad Arolsen
state: Hessen
city: Marburg
country: Germany
facility: Philipps University Marburg, Faculty psychology, department clinical psychology
state: Hessen
Study officials:
affiliation: University Greifswald and Philipps University Marburg
name: Eva-Lotta Brakemeier, Prof. Dr.
role: STUDY_CHAIR
affiliation: Schön Klinik Bad Arolsen (study site)
name: Jörg-Tobias Hof
role: PRINCIPAL_INVESTIGATOR
References: