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

July 3, 2017 updated by: Elisabeth Schramm, University Hospital Freiburg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany, 79104
        • University Medical Center Freiburg, Department of Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Brief Supportive Psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)
Time Frame: 20 weeks after randomization (after acute treatment phase)
20 weeks after randomization (after acute treatment phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKF001906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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