Statistical analysis plan for a parallel group randomized clinical trial comparing schema therapy versus treatment as usual for outpatients with difficult-to-treat depression (DEPRE-ST).

ABSTRACT:

Background

"Difficult-to-treat" depression - here operationalized as either chronic or treatment-resistant depression - encompasses about one third of all patients with depression. Despite its considerable size, the patient group is understudied, and evidence-based psychotherapeutic treatment options are currently limited. The DEPRE-ST trial therefore seeks to investigate beneficial and harmful effects of schema therapy for difficult-to-treat depression.

Methods

This is a randomized multicenter parallel-group superiority clinical trial. A total of 129 patients will be randomized to receive either 30 sessions of individual schema therapy or psychotherapy according to Treatment As Usual, along with psychopharmacological treatment. Participants are assessed before randomization

SUBMITTER: Arendt ITP 

PROVIDER: S-EPMC12403386 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature