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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elisabeth Schramm, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00970437
First received: September 1, 2009
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Chronic Major Depressive Disorder
Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
Behavioral: System of Supportive Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) [ Time Frame: 20 weeks after randomization (after acute treatment phase) ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: April 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970437

Locations
Germany
University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Freiburg, Germany, 79104
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Elisabeth Schramm, PhD University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Principal Investigator: Martin Härter, MD, PhD University Medical Center Hamburg
  More Information

No publications provided by University Hospital Freiburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elisabeth Schramm, PhD, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00970437     History of Changes
Other Study ID Numbers: UKF001906
Study First Received: September 1, 2009
Last Updated: January 8, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014