A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients
NCT ID: NCT04996433
Last Updated: 2023-10-12
Study Results
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Basic Information
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RECRUITING
NA
396 participants
INTERVENTIONAL
2021-12-01
2026-05-31
Brief Summary
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Detailed Description
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Moderator analyses will examine whether childhood maltreatment and methylation of exon IV of the BDNF gene have an impact on the differential efficacy of the treatments. Regarding mediator analyses, it will be examined whether symptom improvements can be explained by an amelioration of interpersonal problems in CBASP and an increase of activity levels in BA. A follow-up survey 48 weeks after the end of the interventions will provide valuable results regarding the long-term outcome of the treatments. Finally, the health economic potential of the interventions will be investigated through cost-benefit analyses in order to provide important information on the cost-effectiveness of implementation in routine care for health policy. Thus, the results of this study will have the potential to relieve the burden of this very serious and cost-intensive disorder while improving human health. In addition, moderator and mediator analyses may guide personalized treatment and enable therapists to more specifically address psychotherapeutic needs of individual PDD patients in the future.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Behavioral Analysis System of Psychotherapy (CBASP)
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) as acute treatment (5 wk. inpatient and 5 wk. either inpatient or dayclinic) followed by continuation treatment (6 wk. outpatient group therapy).
inpatient CBASP individual therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).
inpatient CBASP group therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).
inpatient CBASP nurse contact
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 30 min per session).
inpatient CBASP exercise therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).
outpatient CBASP group therapy
During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).
algorithm-based study medication
All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse:
* 1st line dose escalation (if appropriate)
* 2nd line lithium augmentation
* 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants
* 4th line change of antidepressant.
Behavioral Activation (BA)
Behavioral Activation (BA) as acute treatment (5 wk. inpatient and 5 wk. either inpatient or dayclinic) followed by continuation treatment (6 wk. outpatient group therapy).
inpatient BA individual therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).
inpatient BA group therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).
inpatient BA nurse contact
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 30 min per session)
inpatient BA exercise therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).
outpatient BA group therapy
During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).
algorithm-based study medication
All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse:
* 1st line dose escalation (if appropriate)
* 2nd line lithium augmentation
* 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants
* 4th line change of antidepressant.
Interventions
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inpatient CBASP individual therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).
inpatient CBASP group therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).
inpatient CBASP nurse contact
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 30 min per session).
inpatient CBASP exercise therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).
outpatient CBASP group therapy
During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).
inpatient BA individual therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).
inpatient BA group therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).
inpatient BA nurse contact
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 30 min per session)
inpatient BA exercise therapy
During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).
outpatient BA group therapy
During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).
algorithm-based study medication
All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse:
* 1st line dose escalation (if appropriate)
* 2nd line lithium augmentation
* 3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants
* 4th line change of antidepressant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Total Hamilton Depression Rating Scale (HDRS-24) Score ≥ 20
* Treatment-resistance (TR) (defined as a level of 3 or higher on the Antidepressant Treatment History Form: Short Form (ATHF-SF) or medication intolerance or one psychotherapy at least 25 sessions by a certified therapist in the current episode)
* Sufficient knowledge of the German language
* Written informed consent
Exclusion Criteria
* Active substance use disorders (abstinence shorter than 6 months)
* Schizophrenia spectrum and other psychotic disorders
* Antisocial personality disorder
* Acute suicidality
* Previous CBASP or BA treatment within the last year
* Inability to tolerate CBASP or BA (e.g., organic brain disorders, severe cognitive deficits)
* Inability to participate in dayclinic or outpatient continuation treatment
20 Years
70 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
University of Kassel
OTHER
University Medicine Greifswald
OTHER
Charite University, Berlin, Germany
OTHER
Hannover Medical School
OTHER
University Hospital Lübeck
OTHER
Philipps University Marburg
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University Hospital Tuebingen
OTHER
University of Greifswald
OTHER
Responsible Party
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Principal Investigators
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Eva-Lotta Brakemeier, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Greifswald
Locations
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Charité, University Medicine Berlin
Berlin, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universität zu Lübeck
Lübeck, , Germany
Universitätsklinikum Marburg
Marburg, , Germany
Klinikum der Universität München
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Bernstein DP, Fink LA. CTQ: Childhood Trauma Questionaire: A retrospective self-report.1998; TX: Psychological Corp.
Brakemeier EL, Dobias J, Hertel J, Bohus M, Limberger MF, Schramm E, Radtke M, Frank P, Padberg F, Sabass L, Jobst A, Jacob GA, Struck N, Zimmermann J, Normann C. Childhood Maltreatment in Women with Borderline Personality Disorder, Chronic Depression, and Episodic Depression, and in Healthy Controls. Psychother Psychosom. 2018;87(1):49-51. doi: 10.1159/000484481. Epub 2018 Jan 6. No abstract available.
Brakemeier EL, Engel V, Schramm E, Zobel I, Schmidt T, Hautzinger M, Berger M, Normann C. Feasibility and outcome of cognitive behavioral analysis system of psychotherapy (CBASP) for chronically depressed inpatients: a pilot study. Psychother Psychosom. 2011;80(3):191-4. doi: 10.1159/000320779. Epub 2011 Mar 10. No abstract available.
Brakemeier EL, Normann C. Praxisbuch CBASP: Behandlung chronischer Depression; mit Online-Materialien (1. Aufl). 2012. Weinheim: Beltz.
Brakemeier EL, Guhn A, Normann C. Praxisbuch CBASP: Behandlung chronischer Depression und Modifikationen für weitere interpersonelle Störungen; mit E-Book inside und Arbeitsmaterial; (2., überarbeitete und erweiterte Auflage). 2021; Weinheim: Beltz.
Brakemeier EL, Radtke M, Engel V, Zimmermann J, Tuschen-Caffier B, Hautzinger M, Schramm E, Berger M, Normann C. Overcoming treatment resistance in chronic depression: a pilot study on outcome and feasibility of the cognitive behavioral analysis system of psychotherapy as an inpatient treatment program. Psychother Psychosom. 2015;84(1):51-6. doi: 10.1159/000369586. Epub 2014 Dec 24.
Bschor T, Bauer M, Adli M. Chronic and treatment resistant depression: diagnosis and stepwise therapy. Dtsch Arztebl Int. 2014 Nov 7;111(45):766-75; quiz 775. doi: 10.3238/arztebl.2014.0766.
Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev. 2007 Apr;27(3):318-26. doi: 10.1016/j.cpr.2006.11.001. Epub 2006 Dec 19.
DGPPN, BÄK, KBV, AWMF. S3-Leitlinie/Nationale Versorgungsleitlinie Unipolare Depression- Langfassung: Bd. Version 5 (2. Aufl.). 2015; Springer.
Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.
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Guhn A, Kohler S, Brakemeier EL, Sterzer P. Cognitive Behavioral Analysis System of Psychotherapy for inpatients with persistent depressive disorder: a naturalistic trial on a general acute psychiatric unit. Eur Arch Psychiatry Clin Neurosci. 2021 Apr;271(3):495-505. doi: 10.1007/s00406-019-01038-5. Epub 2019 Jul 12.
Harter M, Sitta P, Keller F, Metzger R, Wiegand W, Schell G, Stieglitz RD, Wolfersdorf M, Felsenstein M, Berger M. [Psychiatric-psychotherapeutic inpatient treatment for depression. Process and outcome quality based on a model project in Baden-Wurttemberg]. Nervenarzt. 2004 Nov;75(11):1083-91. doi: 10.1007/s00115-004-1705-8. German.
Holzel L, Wolff Av, Kriston L, Harter M. [Risk factors for non-response in inpatient depression treatment]. Psychiatr Prax. 2010 Jan;37(1):27-33. doi: 10.1055/s-0029-1223348. Epub 2009 Oct 12. German.
Kohler S, Sterzer P, Normann C, Berger M, Brakemeier EL. [Overcoming treatment resistance in chronic depression : The role of inpatient psychotherapy]. Nervenarzt. 2016 Jul;87(7):701-7. doi: 10.1007/s00115-015-0034-4. German.
McCullough JP, Schramm E, Penberthy K. CBASP as a Distinctive Treatment for Persistent Depressive Disorder. 2014; Routledge. https://doi.org/10.4324/9781315743196
Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14293-6. doi: 10.1073/pnas.2336126100. Epub 2003 Nov 13.
Norcross JC, Wampold BE. Evidence-based therapy relationships: research conclusions and clinical practices. Psychotherapy (Chic). 2011 Mar;48(1):98-102. doi: 10.1037/a0022161.
Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
Sabass L, Padberg F, Normann C, Engel V, Konrad C, Helmle K, Jobst A, Worlitz A, Brakemeier EL. Cognitive Behavioral Analysis System of Psychotherapy as group psychotherapy for chronically depressed inpatients: a naturalistic multicenter feasibility trial. Eur Arch Psychiatry Clin Neurosci. 2018 Dec;268(8):783-796. doi: 10.1007/s00406-017-0843-5. Epub 2017 Sep 27.
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Shinohara K, Honyashiki M, Imai H, Hunot V, Caldwell DM, Davies P, Moore TH, Furukawa TA, Churchill R. Behavioural therapies versus other psychological therapies for depression. Cochrane Database Syst Rev. 2013 Oct 16;2013(10):CD008696. doi: 10.1002/14651858.CD008696.pub2.
Snarski M, Scogin F, DiNapoli E, Presnell A, McAlpine J, Marcinak J. The effects of behavioral activation therapy with inpatient geriatric psychiatry patients. Behav Ther. 2011 Mar;42(1):100-8. doi: 10.1016/j.beth.2010.05.001. Epub 2010 Nov 20.
Tadic A, Muller-Engling L, Schlicht KF, Kotsiari A, Dreimuller N, Kleimann A, Bleich S, Lieb K, Frieling H. Methylation of the promoter of brain-derived neurotrophic factor exon IV and antidepressant response in major depression. Mol Psychiatry. 2014 Mar;19(3):281-3. doi: 10.1038/mp.2013.58. Epub 2013 May 14. No abstract available.
Struck N, Krug A, Yuksel D, Stein F, Schmitt S, Meller T, Brosch K, Dannlowski U, Nenadic I, Kircher T, Brakemeier EL. Childhood maltreatment and adult mental disorders - the prevalence of different types of maltreatment and associations with age of onset and severity of symptoms. Psychiatry Res. 2020 Nov;293:113398. doi: 10.1016/j.psychres.2020.113398. Epub 2020 Aug 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BR 4262/6-1
Identifier Type: -
Identifier Source: org_study_id
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