The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.
About half of all psychiatric inpatients with depression suffer from persistent depressive disorder (PDD). Given their high degree of treatment-resistance (TR), comorbidity, suicidality, and hospitalization rates, this patient group appears to be particularly difficult to treat and, from a health economic perspective, constitutes a major challenge. The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is the only psychotherapy specifically tailored for PDD developed. Originally developed as an outpatient treatment by James P. McCullough, CBASP has been modified for the severely ill PDD patients with TR as a multimodal inpatient concept. Pilot studies indicate very good feasibility and promising outcome. Therefore, a randomized controlled trial is now mandatory for testing the superiority of the inpatient CBASP program vs. the evidence-based Cognitive Behavioral Therapy (CBT), the 'gold standard' in depression treatment. Behavioral Activation (BA) was chosen as the control intervention because BA, as a specific variant of CBT, is at least as effective as standard CBT in severely depressed patients while being easier to train and implement in inpatient settings. Both therapies will be applied as a treatment-phase program (5-week inpatient and dayclinic acute treatment followed by 6-week outpatient continuation group-treatment) in combination with standardized and guideline-based pharmacotherapy. The proposed prospective, multi-center, randomized study with 396 PDD patients with TR will therefore address the primary research question: Is the CBASP program more effective than the BA program in this patient group? The primary hypothesis is that after 16 weeks of treatment, CBASP will show a significant superiority over BA in reducing depressive symptoms. In addition, the important psychotherapy research question: what works for whom and why? will be addressed. Moderator analyses will examine whether childhood maltreatment and methylation of exon IV of the BDNF gene have an impact on the differential efficacy of the treatments. Regarding mediator analyses, it will be examined whether symptom improvements can be explained by an amelioration of interpersonal problems in CBASP and an increase of activity levels in BA. A follow-up survey 48 weeks after the end of the interventions will provide valuable results regarding the long-term outcome of the treatments. Finally, the health economic potential of the interventions will be investigated through cost-benefit analyses in order to provide important information on the cost-effectiveness of implementation in routine care for health policy. Thus, the results of this study will have the potential to relieve the burden of this very serious and cost-intensive disorder while improving human health. In addition, moderator and mediator analyses may guide personalized treatment and enable therapists to more specifically address psychotherapeutic needs of individual PDD patients in the future.
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 30 min per session).
Charité, University Medicine Berlin
Berlin, Germany
RECRUITINGMedizinische Hochschule Hannover
Hanover, Germany
NOT_YET_RECRUITINGUniversität zu Lübeck
Lübeck, Germany
RECRUITINGHamilton Depression Rating Scale (HDRS-24), 24-item version
The change in HDRS-24 item score after 16 weeks 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.
Time frame: 16 weeks
Hamilton Depression Rating Scale (HDRS-24), 24-item version
The HDRS-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 HDRS-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.
Time frame: baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 64
Inventory of Depressive Symptomatology, Self-Report (IDS-SR)
The IDS-SR is a self-reported measure of depressive symptoms and used to detect change in self-rated depression severity. It shows good psychometric properties. Each item is rated from 0 to 3 by the patient, and all values are added up to an overall score. Total score ranges from 0 to 78, with higher values indicating a higher depression severity.
Time frame: baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 32, 40, 48, 56, 64
Brief Symptom Inventory (BSI)
The BSI is a multi-dimensional self-reported measure with a total of nine scales assessing the subjective impairment by physical and psychological symptoms. Each item is rated on a scale from 0 to 5 by the patient and are added up and t-transformed to three global indices: Global Severity Index, Positive Symptom Distress Index, Positive Symptom Total. T-Scores range from 0 to 100, with higher values indicating a higher subjective impairment.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
396
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).
During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 30 min per session)
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).
During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).
All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse: * 1st line dose escalation (if appropriate) * 2nd line lithium augmentation * 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants * 4th line change of antidepressant.
Universitätsklinikum Marburg
Marburg, Germany
RECRUITINGKlinikum der Universität München
München, Germany
RECRUITINGUniversitätsklinikum Tübingen
Tübingen, Germany
RECRUITINGTime frame: baseline, weeks 1, 5, 10, 16, 64
Global Assessment of Functioning (GAF)
The GAF is a diagnostic measure used to assess social, occupational and psychological functioning according to DSM-IV. The score ranges from 0 to 100 with a total of ten levels of functioning and is determined by a clinical rater. Higher scores indicate a higher level of functioning and therefore a better outcome.
Time frame: baseline, weeks 1, 5, 10, 16, 64
World Health Organization Quality of Life (WHOQoL-BREF)
The WHOQoL-BREF is a self-reporting measure regarding the subjective quality of life. Four broad domains of quality of life are rated by the patient on a five point scale and a mean score for each domain is calculated. Scores range between 4 and 20, with a higher score indicating a higher quality of life and therefore a better outcome.
Time frame: baseline, weeks 1, 5, 10, 16, 64
Response
Response (50% decrease on HDRS-24 score)
Time frame: baseline, weeks 1, 5, 10, 16, 64
Remission
Remission (HDRS-24 score of 10 or less)
Time frame: baseline, weeks 1, 5, 10, 16, 64
Relapse rates
Relapse rates (rehospitalization, increase of HDRS-24 of equal or greater than 10 or current HDRS-24 score of equal or greater than 18 points) are measured.
Time frame: 16, 64
Cost interview
The cost interview assesses direct medical and non-medical costs and indirect costs due to mental disorders versus physical illnesses.
Time frame: baseline, weeks 16 and 64