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Recruiting NCT04996433

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

Trial Parameters

Condition Persistent Depressive Disorder
Sponsor University of Greifswald
Study Type INTERVENTIONAL
Phase N/A
Enrollment 396
Sex ALL
Min Age 20 Years
Max Age 70 Years
Start Date 2021-12-01
Completion 2024-07
Interventions
inpatient CBASP individual therapyinpatient CBASP group therapyinpatient CBASP nurse contact

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.

Eligibility Criteria

Inclusion Criteria: * 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 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: * 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 * 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

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