F32
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Primary diagnosis of depression, with at least moderate severity (> 16 points in the Hamilton Rating Scale for Depression (HRSD-24) and aversive childhood experiences (recorded with the Childhood Trauma Questionnaire (CTQ): Sum score on at least one of the CTQ subscales for sexual, physical, emotional abuse or emotional neglect above the cut-off for moderate abuse), 18-65 years, informed consent, sufficient knowledge of German (also in writing)
Exclusion criteria
Exclusion criteria: Exclusion criteria: Post-traumatic stress disorder, psychotic/bipolar disorder, IQ 2 sessions)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the severity of depressive symptoms at follow-up 1 (six month after start of treatment) assessed with Hamilton Rating Scale for Depression (HRSD-24) | — |
Secondary
| Measure | Time frame |
|---|---|
| All of the following outcome measures are collected at the following points in time: 6 weeks after the start (mid-treatment) After completion of the treatment (post-treatment) 6 months after start (follow-up 1) 9 months after start (follow-up 2) Depressive symptoms using the Hamilton Rating Scale for Depression (HRSD-24) Depressive symptoms in the self-rating Patient Health Questionnaire (PHQ-9) Dysfunctional basic assumptions (own questionnaire) Stress caused by aversive memories (single item) Self-compassion using the Self-Compassion Scale Short Version (SCS-SV) Emotion regulation using the questionnaire for self-assessment of emotional competencies (SEK-27) Negative effects of psychotherapy using the Negative Effects Questionnaire (NEQ) Serious adverse events using the Serious Adverse Event Interview Treatment satisfaction using the Patient Satisfaction Questionnaire (ZUF-8) Health related quality of life using WHO Quality of life, short version (WHOQOL-BREF) For each session, the therapists also assess depressive symptoms (using the PHQ-9), stress caused by aversive memories and the five most personally relevant basic assumptions using questionnaires, as well as serious adverse events (SAE). Using a self-conducted, semi-structured qualitative interview, the patients will be asked about their experiences with the treatment after completion of the treatment, what changes they experience, which factors they experienced as hindering or helpful and how they assess the cost-benefit ratio of the treatment. | — |
Countries
Germany
Contacts
Universität zu Lübeck