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

Chronic Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970437
• Other study ID #: UKF001906
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: July 3, 2017
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: July 2017
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Major Depressive Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg, Department of Psychiatry and Psychotherapy	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schramm E, Kriston L, Zobel I, Bailer J, Wambach K, Backenstrass M, Klein JP, Schoepf D, Schnell K, Gumz A, Bausch P, Fangmeier T, Meister R, Berger M, Hautzinger M, Härter M. Effect of Disorder-Specific vs Nonspecific Psychotherapy for Chronic Depression — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)		20 weeks after randomization (after acute treatment phase)