A Comparison of Two Psychotherapy Programs in Persistently Depressed Treatment-Resistant Inpatients

NCT04996433 | Recruiting DMC

• 1 other identifier: BR 4262/6-1
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) conducted over 16 weeks (acute and continuation treatment) with Behavioral Activation (BA; same dose and duration) in persistently depressed treatment-resistant inpatients regarding efficacy, moderators and mediators of change.

Conditions

Persistent Depressive Disorder; Treatment-resistant Depression

Keywords

Psychotherapy; Depression; Inpatient Treatment; Child Maltreatment; Epigenetic; Moderator; Mediator; Efficacy

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS-24), 24-item version

  The change in HDRS-24 item score after 16 weeks will be the primary endpoint. The HRSD-24 is a semi-structured interview which is used to measure the severity of all symptom domains of depression as described by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) over a period of the last 7 days. It shows good psychometric properties. The HRSD-24 will be conducted by blind study raters at every time point. Raters evaluate symptom severity on a scale from 0 to 2 or 0 - 3 or 0 - 4 for each item, with higher number indicating higher symptom severity. The total score ranges from 0 to 75 with higher values indicating higher depression severity.

  16 weeks

Secondary Outcomes (9)

• Hamilton Depression Rating Scale (HDRS-24), 24-item version

  baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 64

• Inventory of Depressive Symptomatology, Self-Report (IDS-SR)

  baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 32, 40, 48, 56, 64

• Brief Symptom Inventory (BSI)

  baseline, weeks 1, 5, 10, 16, 64

• Global Assessment of Functioning (GAF)

  baseline, weeks 1, 5, 10, 16, 64

• World Health Organization Quality of Life (WHOQoL-BREF)

  baseline, weeks 1, 5, 10, 16, 64

Other Outcomes (5)

• Childhood Trauma Questionnaire (CTQ)

  Baseline

• Brain-derived neurotrophic factor (BDNF)

  Baseline

• Inventory of Interpersonal Problems-revised (IIP-32-R)

  Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 64

Study Arms (2)

Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

EXPERIMENTAL

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).

Behavioral: inpatient CBASP individual therapy; Behavioral: inpatient CBASP group therapy; Behavioral: inpatient CBASP nurse contact; Behavioral: inpatient CBASP exercise therapy; Behavioral: outpatient CBASP group therapy; Drug: algorithm-based study medication

Behavioral Activation (BA)

ACTIVE COMPARATOR

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).

Behavioral: inpatient BA individual therapy; Behavioral: inpatient BA group therapy; Behavioral: inpatient BA nurse contact; Behavioral: inpatient BA exercise therapy; Behavioral: outpatient BA group therapy; Drug: algorithm-based study medication

Interventions

inpatient CBASP individual therapy BEHAVIORAL

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).

Also known as: Cognitive Behavioral Analysis System of Psychotherapy - inpatient individual therapy

Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

inpatient CBASP group therapy BEHAVIORAL

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).

Also known as: Cognitive Behavioral Analysis System of Psychotherapy - inpatient group therapy

Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

inpatient CBASP nurse contact BEHAVIORAL

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: 25 min per session).

Also known as: Cognitive Behavioral Analysis System of Psychotherapy - inpatient nurse contact

Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

inpatient CBASP exercise therapy BEHAVIORAL

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).

Also known as: Cognitive Behavioral Analysis System of Psychotherapy - inpatient exercise therapy

Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

outpatient CBASP group therapy BEHAVIORAL

During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).

Also known as: Cognitive Behavioral Analysis System of Psychotherapy - outpatient group therapy

Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

inpatient BA individual therapy BEHAVIORAL

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).

Also known as: Behavioral Activation - inpatient individual therapy

Behavioral Activation (BA)

inpatient BA group therapy BEHAVIORAL

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).

Also known as: Behavioral Activation - inpatient group therapy

Behavioral Activation (BA)

inpatient BA nurse contact BEHAVIORAL

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: 25 min per session)

Also known as: Behavioral Activation - inpatient nurse contact

Behavioral Activation (BA)

inpatient BA exercise therapy BEHAVIORAL

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).

Also known as: Behavioral Activation - inpatient exercise therapy

Behavioral Activation (BA)

outpatient BA group therapy BEHAVIORAL

During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).

Also known as: Behavioral Activation - outpatient group therapy

Behavioral Activation (BA)

algorithm-based study medication DRUG

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.

Also known as: antidepressant medication

Behavioral Activation (BA); Cognitive Behavioral Analysis System of Psychotherapy (CBASP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary DSM-5 diagnosis of PDD (300.4, 296.2x, 296.3x)
• Total Hamilton Depression Rating Scale (HDRS-24) Score ≥ 20
• Treatment-resistance (TR) (defined by the 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

You may not qualify if:

• Bipolar I or II disorder
• Active substance use disorders (abstinence shorter than 6 months)
• Schizophrenia spectrum and other psychotic disorders
• Antisocial personality disorder
• Acute suicidality (HRSD item 3 \> 2 or agreement with C-SSRS item 4 and/or item 5)
• 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
• Participation in another (psycho)therapeutic study of an interventional nature

Sponsors & Collaborators

• University of Greifswald: lead
• German Research Foundation: collaborator
• University of Kassel: collaborator
• University Medicine Greifswald: collaborator
• Charite University, Berlin, Germany: collaborator
• Hannover Medical School: collaborator
• University Hospital Lübeck: collaborator
• Philipps University Marburg: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• University Hospital Tuebingen: collaborator
• University Hospital, Bonn: collaborator
• Jena University Hospital: collaborator

Study Sites (8)

Charité, University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

TERMINATED

Universitätsklinikum Jena

Jena, 07743, Germany

RECRUITING

Universität zu Lübeck

Lübeck, 23562, Germany

RECRUITING

Universitätsklinikum Marburg

Marburg, 35039, Germany

RECRUITING

Klinikum der Universität München

München, 80336, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Eva-Lotta Brakemeier, Prof. Dr.

  University Greifswald

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva-Lotta Brakemeier, Prof. Dr.

CONTACT

+49 3834 420; eva-lotta.brakemeier@uni-greifswald.de

Johannes Zimmermann, Prof. Dr.

CONTACT

+49 561 804; jz@uni-kassel.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of interventions, blinding of patients/therapists concerning the treatment program is impossible, but all assessments as well as data analysis will be blinded to treatment allocation. Notably, patients are blinded to the study hypothesis by the Informed Consent process, as patients are told in the patient information and educational discussions about the study that they will in any case receive one of two different scientifically based psychotherapy programs, although it is unclear which of the two programs is more effective, one program focuses on coping with interpersonal problems, the other on building up activities that seem important for personal life. Similarly, the members of the treatment teams of each study ward are not informed about the study hypothesis; however, they are informed that it has not yet been scientifically clarified which therapy is more effective.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, evaluator-blinded, parallel-group, randomized controlled intervention trial with an active control condition

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: August 9, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We will make the outcome data and then the covariate data freely available after our respective publications, but not before 01.01.2028.
• Access Criteria: data will be shared with the public; data will be made available for all what types of analyses; the mechanism by which the data will be made available will be determined soon.

Locations

DE (8)