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

NCT03616665 | Unknown DMC

• 1 other identifier: 2018_14k
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale of Depression, 24-item version (HRSD-24)

  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.

  The primary outcome is given by the post value (week six: end of inpatient treatment) in the HRSD24.

Secondary Outcomes (21)

• Beck Depression Inventory-II (BDI-II)

  Baseline, 2, 4, 6, 8, 9, 14, and 37 weeks after study start

• Montgomery Asberg Depression Rating Scale (MADRS)

  Baseline, 2, 4, 6, 14, and 37 weeks after study start

• Brief Symptom Inventory (BSI)

  Baseline, 6, 14, and 37 weeks after study start

• Patient Health Questionnaire (PHQ)

  Baseline, 6, 14, and 37 weeks after study start

• Inventory of Personality Organization (IPO-16)

  Baseline, 6, 14, and 37 weeks after study start

Other Outcomes (9)

• Moderator variable: Childhood Trauma Questionnaire (CTQ-SF)

  baseline

• Process variable: Inventory of Interpersonal Problems (IIP)

  Baseline, 6, 14 and 37 weeks after study start

• General Self-Efficacy Scale (GSE; Jerusalem & Schwarzer, 1999)

  Baseline, 6, 14 and 37 weeks after study start

Study Arms (1)

CBASPersonalized

OTHER

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.

Other: CBASPersonalized

Interventions

CBASPersonalized 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.

Also known as: Drug

CBASPersonalized

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• Schön Klinik Bad Arolsen: collaborator

Study Sites (2)

Schoen Klinik Bad Arolsen

Bad Arolsen, Hesse, 34454, Germany

RECRUITING

Philipps University Marburg, Faculty psychology, department clinical psychology

Marburg, Hesse, 35032, Germany

RECRUITING

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

• Eva-Lotta Brakemeier, Prof. Dr.

  University Greifswald and Philipps University Marburg

  STUDY CHAIR

• Jörg-Tobias Hof

  Schön Klinik Bad Arolsen (study site)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva-Lotta Brakemeier, Prof. Dr.

CONTACT

+491711278600; eva-lotta.brakemeier@uni-greifswald.de

Thomas Gärtner, Dr.

CONTACT

+49 569162383099; tgaertner@schoen-klinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 6, 2018
• Study Start: April 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2021
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: These above mentioned proposals should be submitted within 48 months following first publication of the main results of this trial.

Locations

DE (2)