search
Back to results

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

Primary Purpose

Chronic Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive Behavioral Analysis System of Psychotherapy
System of Supportive Psychotherapy
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Medical Center Freiburg, Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBASP

SYSP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)

Secondary Outcome Measures

Full Information

First Posted
September 1, 2009
Last Updated
July 3, 2017
Sponsor
University Hospital Freiburg
search

1. Study Identification

Unique Protocol Identification Number
NCT00970437
Brief Title
A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
Official Title
A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBASP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SYSP
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Analysis System of Psychotherapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
System of Supportive Psychotherapy
Other Intervention Name(s)
Brief Supportive Psychotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)
Time Frame
20 weeks after randomization (after acute treatment phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Early onset of the disorder according to DSM-IV (onset before the age of 21) Age between 18 and 65 A score of at least 20 on the 24-item HRSD at screening and, after a 2-week drug-free period, at baseline Fluent in German language Provide informed consent Exclusion Criteria: 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. A history of psychotic symptoms, bipolar disorder, or organic brain disorders 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 Antisocial, schizotypical, or borderline personality disorder (SCID-II); Severe cognitive impairment Absence of a response to previous adequate trial of CBASP, and/or SYSP Other ongoing psychotherapy or medication A serious medical condition (i.e. a history of seizures, severe head trauma, stroke or heart attack within six months before the study began)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Schramm, PhD
Organizational Affiliation
University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Härter, MD, PhD
Organizational Affiliation
University Medical Center Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
City
Freiburg
ZIP/Postal Code
79104
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28146251
Citation
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, Harter M. Effect of Disorder-Specific vs Nonspecific Psychotherapy for Chronic Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Mar 1;74(3):233-242. doi: 10.1001/jamapsychiatry.2016.3880.
Results Reference
result
PubMed Identifier
33455531
Citation
Humer E, Schramm E, Klein JP, Harter M, Hautzinger M, Pieh C, Probst T. Effects of alliance ruptures and repairs on outcomes. Psychother Res. 2021 Nov;31(8):977-987. doi: 10.1080/10503307.2021.1874070. Epub 2021 Jan 17.
Results Reference
derived
PubMed Identifier
31576565
Citation
Meister R, Lanio J, Fangmeier T, Harter M, Schramm E, Zobel I, Hautzinger M, Nestoriuc Y, Kriston L. Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. J Clin Psychol. 2020 Jan;76(1):7-19. doi: 10.1002/jclp.22869. Epub 2019 Oct 1.
Results Reference
derived
PubMed Identifier
30199128
Citation
Assmann N, Schramm E, Kriston L, Hautzinger M, Harter M, Schweiger U, Klein JP. Moderating effect of comorbid anxiety disorders on treatment outcome in a randomized controlled psychotherapy trial in early-onset persistently depressed outpatients. Depress Anxiety. 2018 Oct;35(10):1001-1008. doi: 10.1002/da.22839. Epub 2018 Sep 10.
Results Reference
derived
PubMed Identifier
29685124
Citation
Eich HS, Kriston L, Schramm E, Bailer J. The German version of the helping alliance questionnaire: psychometric properties in patients with persistent depressive disorder. BMC Psychiatry. 2018 Apr 23;18(1):107. doi: 10.1186/s12888-018-1697-8.
Results Reference
derived
PubMed Identifier
29329058
Citation
Erkens N, Schramm E, Kriston L, Hautzinger M, Harter M, Schweiger U, Klein JP. Association of comorbid personality disorders with clinical characteristics and outcome in a randomized controlled trial comparing two psychotherapies for early-onset persistent depressive disorder. J Affect Disord. 2018 Mar 15;229:262-268. doi: 10.1016/j.jad.2017.12.091. Epub 2018 Jan 4.
Results Reference
derived
PubMed Identifier
21849054
Citation
Schramm E, Hautzinger M, Zobel I, Kriston L, Berger M, Harter M. Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus supportive psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial. BMC Psychiatry. 2011 Aug 17;11:134. doi: 10.1186/1471-244X-11-134.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs