Chronic Major Depressive DisorderNCT00970437
A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
A study testing Cognitive Behavioral Analysis System of Psychotherapy and System of Supportive Psychotherapy in people with Chronic Major Depressive Disorder, run by University Hospital Freiburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Major Depressive Disorder
- What is being tested?
- Cognitive Behavioral Analysis System of Psychotherapy and System of Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Freiburg im Breisgau, 79104
About this study
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.
Read the 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
- Conditions
- Chronic Major Depressive Disorder
- Being tested
- Cognitive Behavioral Analysis System of Psychotherapy, System of Supportive Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Analysis System of PsychotherapyBehavioural
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 PsychotherapyBehavioural
Also called Brief 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
| Study group | Role | What they receive |
|---|---|---|
| CBASP | Active comparator | 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. Receives: Behavioral: Cognitive Behavioral Analysis System of Psychotherapy |
| SYSP | Placebo comparator | 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. Receives: Behavioral: System of Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)
Measured: 20 weeks after randomization (after acute treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Schramm, University Hospital Freiburg
- Investigators
- Elisabeth Schramm, PhD, Principal investigator, University Medical Center Freiburg, Department of Psychiatry and PsychotherapyMartin Härter, MD, PhD, Principal investigator, University Medical Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970437
- Sponsor's protocol ID
- UKF001906
- Status last verified
- Jul 2017
- First submitted
- 1 Sep 2009
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28146251Echterhoff J, Kriston L, Klein JP, Harter M, Schramm E, Schumacher L. Symptom-specific improvement across therapies and their putative mediators: A mediation network intervention analysis. Psychother Res. 2025 Apr;35(4):546-557. doi: 10.1080/10503307.2024.2320349. Epub 2024 Mar 3.
PubMed 38431848Schumacher L, Klein JP, Elsaesser M, Harter M, Hautzinger M, Schramm E, Kriston L. Implications of the Network Theory for the Treatment of Mental Disorders: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1160-1168. doi: 10.1001/jamapsychiatry.2023.2823.
PubMed 37610747Humer 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.
PubMed 33455531Meister 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.
PubMed 31576565Assmann 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.
PubMed 30199128Eich 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.
PubMed 29685124Erkens 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.
PubMed 29329058Schramm 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.
PubMed 21849054
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and System of Supportive Psychotherapy (SYSP) for Early Onset Chronic Depression
- ClinicalTrials.gov ID
- NCT00970437
- Acronym / sponsor ID
- UKF001906
- Conditions
- Chronic Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBASP | Active comparator | Behavioral: Cognitive Behavioral Analysis System of PsychotherapyCBASP 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. |
| SYSP | Placebo comparator | Behavioral: System of Supportive PsychotherapyThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Analysis System of PsychotherapyDuration 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 | Behavioural | CBASP |
| System of Supportive PsychotherapyAlso: Brief Supportive PsychotherapyDuration 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 | Behavioural | SYSP |
Primary outcome
Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression)
Time frame: 20 weeks after randomization (after acute treatment phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Results publication: PubMed 28146251Schramm 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.
- Derived from this study: PubMed 38431848Echterhoff J, Kriston L, Klein JP, Harter M, Schramm E, Schumacher L. Symptom-specific improvement across therapies and their putative mediators: A mediation network intervention analysis. Psychother Res. 2025 Apr;35(4):546-557. doi: 10.1080/10503307.2024.2320349. Epub 2024 Mar 3.
- Derived from this study: PubMed 37610747Schumacher L, Klein JP, Elsaesser M, Harter M, Hautzinger M, Schramm E, Kriston L. Implications of the Network Theory for the Treatment of Mental Disorders: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1160-1168. doi: 10.1001/jamapsychiatry.2023.2823.
- Derived from this study: PubMed 33455531Humer 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.
- Derived from this study: PubMed 31576565Meister 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.
- Derived from this study: PubMed 30199128Assmann 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.
- Derived from this study: PubMed 29685124Eich 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.
- Derived from this study: PubMed 29329058Erkens 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.
- Derived from this study: PubMed 21849054Schramm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Schramm, PhD principal investigator
University Medical Center Freiburg, Department of Psychiatry and Psychotherapy
Martin Härter, MD, PhD principal investigator
University Medical Center Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Analysis System of Psychotherapy and System of Supportive Psychotherapy in people with Chronic Major Depressive Disorder, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970437, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.