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A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elisabeth Schramm, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00970437
First received: September 1, 2009
Last updated: July 3, 2017
Last verified: July 2017
September 1, 2009
July 3, 2017
April 2010
October 2013   (Final data collection date for primary outcome measure)
Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) [ Time Frame: 20 weeks after randomization (after acute treatment phase) ]
Same as current
Complete list of historical versions of study NCT00970437 on ClinicalTrials.gov Archive Site
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A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
The purpose of this study is to compare the efficacy of the Cognitive Behavioural Analysis System of Psychotherapy (CBASP) with the non-specific System of Supportive Psychotherapy (SYSP)in early onset chronically depressives.

Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional interventions are not as effective as in acute, episodic depression. In addition, most of the studies had methodological weaknesses, such as the very short courses of psychotherapy. Usually, chronic depression begins early in life, is often associated with early interpersonal trauma, and results in an even more substantial human capital loss than the late-onset group. Furthermore, it shows a weak response to medication and a high rate of relapse after an initial response. With the present multicentre study, the efficacy of the only specific psychotherapy for chronic depression (Cognitive Behavioural Analysis System of Psychotherapy/CBASP) is compared with a non-specific System of Supportive Psychotherapy/SYSP in early onset chronically depressives. CBASP faired very well in one large trial but has never been directly compared to a non-specific psychotherapeutic control. Another innovative aspect of the study is the use of an extended course of psychotherapy (32 sessions). Primary hypothesis: CBASP is more effective in reducing depressive symptoms than SYSP.

A naturalistic study following up the patients of the trial up to two years after termination of the study treatments is performed in order to investigate the long-term effectiveness of CBASP compared to the System of Supportive Psychotherapy. The primary outcome of this follow-up study is the rate of well-weeks (weeks with no or minimal depression symptoms) during the two years after termination of the study treatments as measured with the Longitudinal Interval Follow-up Evaluation (LIFE) Interview

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Major Depressive Disorder
  • Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
    Duration of intervention per patient: 20 weeks acute treatment (n=24 sessions) followed by 28 weeks of continuation treatment (n=8 sessions) Follow-up per patient: 48 weeks after randomisation
  • Behavioral: System of Supportive Psychotherapy
    Duration of intervention per patient: 20 weeks acute treatment (n=24 sessions) followed by 28 weeks of continuation treatment (n=8 sessions) Follow-up per patient: 48 weeks after randomisation
    Other Name: Brief Supportive Psychotherapy
  • Active Comparator: CBASP
    CBASP as the experimental intervention will follow a manual (McCullough, 2000; German version: Schramm et al., 2006). The approach is specifically tailored for the treatment of chronic forms of depression, particularly with early-onset by focusing on the problems resulting from an inhibition of maturation in early childhood and by using the therapeutic relationship in a personal, disciplined way as well as other specific techniques (e.g. Interpersonal Discrimination Exercise, Situation Analysis). CBASP integrates behavioural, cognitive, and interpersonal strategies.
    Intervention: Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
  • Placebo Comparator: SYSP
    The comparator for CBASP is SYSP, a system of supportive psychotherapy, an active but less specific, manualized control treatment. SYSP - defined as non-interpersonal and non-cognitive-behavioral therapy - resembles supportive clinical management, client-centered therapy, counseling, and psychoeducation about depression. There is no specific explanatory mechanism for treatment effect offered to the patient and it does not focus on specific themes.
    Intervention: Behavioral: System of Supportive Psychotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
December 2014
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. DSM-IV criteria for a current episode of chronic MDD, MDD superimposed on a pre-existing dysthymic disorder or recurrent MDD with incomplete remission between episodes in a patient with a current MDD and a total duration of at least 2 years.
  2. Early onset of the disorder according to DSM-IV (onset before the age of 21)
  3. Age between 18 and 65
  4. A score of at least 20 on the 24-item HRSD at screening and, after a 2-week drug-free period, at baseline
  5. Fluent in German language
  6. Provide informed consent

Exclusion Criteria:

  1. Acute risk for suicide (as opposed to suicidal thoughts) assessed according to clinical practice guidelines. Suicidal patients are eligible, as long as outpatient treatment is deemed safe by the clinician.
  2. A history of psychotic symptoms, bipolar disorder, or organic brain disorders
  3. A primary diagnosis of another axis I disorder including anxiety disorders (e.g. Posttraumatic Stress Disorder), or any severe substance-related abuse or dependence disorder as evaluated with the SCID-I
  4. Antisocial, schizotypical, or borderline personality disorder (SCID-II);
  5. Severe cognitive impairment
  6. Absence of a response to previous adequate trial of CBASP, and/or SYSP
  7. Other ongoing psychotherapy or medication
  8. A serious medical condition (i.e. a history of seizures, severe head trauma, stroke or heart attack within six months before the study began)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00970437
UKF001906
Yes
Not Provided
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Elisabeth Schramm, University Hospital Freiburg
University Hospital Freiburg
Not Provided
Principal Investigator: Elisabeth Schramm, PhD University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Principal Investigator: Martin Härter, MD, PhD University Medical Center Hamburg
University Hospital Freiburg
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP