F32.1 F32.2 F33.1 F33.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: episodic or persistent MDD or MDD superimposed on Dysthymia (“Double Depression”) as the primary diagnosis (SCID I); a score of > 18 on the Hamilton Rating Scale for Depression (HRSD-24); history of childhood maltreatment (at least moderate to severe in one or more of the five categories: emotional neglect or abuse, physical neglect or abuse, sexual abuse); comorbidity on axis I or II (SCID I and II) except for those described in the exclusion criteria; exceeding the “cut-off” value (defined as 1 standard deviation from the population mean) of at least one of the following measures: 1) Rejection Sensitivity Questionnaire (RSQ = 9.88), 2) Interpersonal Reactivity Index (IRI < 45), or 3) State-based Difficulties in Emotion Regulation Scale (S-DERS = 46.97); age 18 to 65; sufficient German language comprehension, informed consent
Exclusion criteria
Exclusion criteria: acute risk of suicide; other current axis I disorders as primary diagnosis; schizophrenia, bipolar I disorder, organic disorders, substance dependence fulfilling criteria within the last 6 months; antisocial or borderline personality disorder (BPD; traits are allowed); severe cognitive impairment, serious medical condition (interfering with participation in regular sessions), other ongoing psychotherapy or psychotropic medication except selective serotonin reuptake inhibitor (SSRI) / serotonin–norepinephrine reuptake inhibitor (SNRI) if stable for at least three weeks before inclusion (fluoxetin four weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression (HRSD-24) at the conclusion of the 16-week treatment period, as measured by blind, independent raters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-Treatment & Follow-Up (6 months): 1. Rejection Sensitivity Questionnaire (RSQ) 2. Interpersonal Reactivity Index (IRI) 3. State-based Difficulties in Emotion Regulation Scale (S-DERS) 4. HRSD-24 Wert 6 months after end of treatment 5. Response and remission rates (response: at least 50% reduction of the baseline HRSD-24 and <16; remission: HRSD-24 Wert = 8) 6. Social and Occupational Functioning Assessment Scale (SOFAS) 7. WHO Quality of Life Instrument (WHOQOL-BREF) 8. Mentalization Questionnaire (MZQ) 9. Beck Depression Inventory (BDI-II) 10. Beck Anxiety Scale (BAI) 11. Patient Health Questionnaire (PHQ-9) 12. Experiences in Close Relationships Revised (ECR-RD) 13. Scale of Body Connection (SBC) 14. Working Alliance Inventory (WAI) | — |
Countries
Germany
Contacts
Klinik für Psychiatrie und Psychotherapie