Depressive and related disorders (DSM-V): major depressive disorder (single episode, recurrent), persistent depressive disorder, other specified depressive disorders F32 F33 F34.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Outpatients, Cognitive-behavioral (CBT) or Psychodynamic (PDT) therapy, once-weekly 50min sessions; both sexes; = 18 yrs.; primary DSM-V diagnosis of depressive and related disorders; BDI-II score = 20
Exclusion criteria
Exclusion criteria: Current/past diagnosis of psychotic disorder or dementia; substance dependency disorder (current/during the last 12 months); acute suicidal plans or attempts within the last 6 months; psychopharmacotherapy other than antidepressants or change of antidepressant regimen during the last month or planned for the next months; planned concurrent psychological treatments (e.g.; inpatient/day-care treatment; outpatient treatments > 4 sessions); insufficient command of the German language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) change in patient-rated depressive symptoms (first primary endpoint) measured using the BDI-II (difference from baseline to 20 weeks after randomization), b) premature therapy dropout (second primary endpoint), patient interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| - change in patient-rated depressive symptoms (BDI-II) (difference from baseline to 35 weeks, 20 months, 36 months after randomization) - dropout at 35 weeks, 20 months, 36 months - change in observer-rated depressive symptoms (difference from baseline to 20, 35 weeks, 20, 36 months after randomization) (GRID-HAM-D) - change in patient-rated anxiety (difference from baseline to 20, 35 weeks, 20, 36 months after randomization (GAD-7) - change in patient-rated somatic symptoms (difference from baseline to 20, 35 weeks, 20, 36 months after randomization) (PHQ-15) - change in patient-rated personality structure deficits (difference from baseline to 20, 35 weeks, 20, 36 months after randomization) (OPD-SQS) - change in patient-rated interpersonal problems (difference from baseline to 20, 35 weeks, 20, 36 months after randomization) (IIP-32) - change in patient-rated quality of life (difference from baseline to 20, 35 weeks, 20, 36 months after randomization) (WHOQOL–BREF) - change in observer-rated therapeutic competence (interpersonal skills) (difference from baseline to week 35 after randomization of the first patient) (Facilitative Interpersonal Skills Performance Test, FIS) - change in therapist-rated trait-like relational manner in therapy and change in therapist-rated therapeutic competence (difference from baseline to 20 weeks, 35 weeks, 20 months, 36 months after randomization of the first patient) (trait section and skills change index section of the Adapted Trainee Current Practice Report. - therapist-rated retrospective satisfaction with supervision at week 20, 35 and months 20 and 36 after randomization of the first patient (CSQ-8) - change in therapist-rated emotional suppression (difference from baseline to 20 weeks, 35 weeks, 20 months, 36 months after randomization of the first patient) (ERQ) - change in alexithymia (difference from baseline to 20 weeks, 35 weeks, 20 months, 36 months after randomization of the first patient) (TAS-26) | — |
Countries
Germany
Contacts
Psychologische Hochschule Berlin