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

NCT00970437 | Completed DMC

• 1 other identifier: UKF001906
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  20 weeks after randomization (after acute treatment phase)

Study Arms (2)

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.

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.

Behavioral: System of Supportive Psychotherapy

Interventions

Cognitive Behavioral Analysis System of Psychotherapy BEHAVIORAL

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

CBASP

System of Supportive Psychotherapy BEHAVIORAL

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

Also known as: Brief Supportive Psychotherapy

SYSP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Medical Center Freiburg, Department of Psychiatry and Psychotherapy

Freiburg im Breisgau, 79104, Germany

Location

Related Publications (9)

• 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.

  PMID: 28146251 RESULT

• Echterhoff 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.

  PMID: 38431848 DERIVED

• Schumacher 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.

  PMID: 37610747 DERIVED

• 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.

  PMID: 33455531 DERIVED

• 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.

  PMID: 31576565 DERIVED

• 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.

  PMID: 30199128 DERIVED

• 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.

  PMID: 29685124 DERIVED

• 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.

  PMID: 29329058 DERIVED

• 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.

  PMID: 21849054 DERIVED

Study Officials

• Elisabeth Schramm, PhD

  University Medical Center Freiburg, Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

• Martin Härter, MD, PhD

  University Medical Center Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: April 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

DE (1)