NCT Number: NCT04996433
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.
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Request Info18 year–75 year
All sexes
Interventional
Not applicable
Charité, University Medicine Berlin, Berlin, State of Berlin, Germany
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. 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 (10-week inpatient/ 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 child 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 the differential efficacy of the treatments can be explained by treatment-specific changes in interpersonal problems or activity levels. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Cognitive Behavioral Analysis System of Psychotherapy - inpatient individual therapy
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).
Other names: Cognitive Behavioral Analysis System of Psychotherapy - inpatient group therapy
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: 25 min per session).
Other names: Cognitive Behavioral Analysis System of Psychotherapy - inpatient nurse contact
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).
Other names: Cognitive Behavioral Analysis System of Psychotherapy - inpatient exercise therapy
During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).
Other names: Cognitive Behavioral Analysis System of Psychotherapy - outpatient group therapy
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).
Other names: Behavioral Activation - inpatient individual therapy
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).
Other names: Behavioral Activation - inpatient group therapy
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: 25 min per session)
Other names: Behavioral Activation - inpatient nurse contact
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).
Other names: Behavioral Activation - inpatient exercise therapy
During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).
Other names: Behavioral Activation - outpatient group therapy
All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse:
Other names: antidepressant medication
Time frame: 16 weeks
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: baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 64
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, 24, 32, 40, 48, 56, 64
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, 5, 10, 16, 64
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.
Time frame: baseline, weeks 1, 5, 10, 16, 64
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
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: weeks 5, 10, 16, 64
Response (50% decrease on HDRS-24 score)
Time frame: weeks 5, 10, 16, 64
Remission (HDRS-24 score of 10 or less)
Time frame: 16, 64
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: baseline, weeks 16 and 64
The cost interview assesses direct medical and non-medical costs and indirect costs due to mental disorders versus physical illnesses.
Time frame: Baseline
Childhood maltreatment by the definition of the World Health Organization (WHO) is assessed as a main moderator at baseline. The CTQ measures self-reported childhood trauma on five subscales. Responses are measured on a five point scale, and each subscale score has a range from 5 to 25 points. Higher scores indicate a higher severity in childhood trauma and therefore a worse outcome.
Time frame: Baseline
Brain-derived neurotrophic factor (BDNF) methylation as a main moderator.
Time frame: Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 64
The IIP-32-R is a self-reported questionnaire that assesses the severity of interpersonal problems on eight scales based on the two-dimensional interpersonal circumplex model as a main mediator. The items are rated on a five-point scale by the patients. A mean score is calculated, ranging from 0 to 4. A higher score indicates a higher severity of interpersonal problems and therefore a worse outcome.
Time frame: Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 64
This self-report is designed to measure weekly changes in avoidance and activation during treatment with Behavioral Activation for depression. The BADS consists of 25 questions on four subscales, each rated on a seven point scale ranging from 0 to 6. The subscales are activation, avoidance/rumination, work/school impairment, and social impairment. A higher total score represents a higher level of activation and therefore a better outcome, while a high score in the subscale social impairment indicates a higher level of impairment and therefore a worse outcome. Scores range from 0 to 150.
Time frame: Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 64
Actimeter-measured step-counts as a main mediator.
Contact information is provided by the study sponsor or research team.
Eva-Lotta Brakemeier, Prof. Dr.
CONTACT
+49 3834 420 ext. 3718
Johannes Zimmermann, Prof. Dr.
CONTACT
+49 561 804 ext. 3833
University of Greifswald
Other
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Behavioral Activation (BA) in Persistently Depressed Treatment-resistant Inpatients: Efficacy, Moderators, and Mediators of Change
Acronym: ChangePDD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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