Major depressive disorder, conform criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Mental and Behavioural Disorders Major depressive disorder
Conditions
Interventions
Current interventions as of 01/10/2015:
Patients will be randomly assigned to one of two treatments:
1. Manual-based cognitive-behavioral treatment condition (CBT)
2. Manual-based short term psychodyn
Sponsors
Ghent University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 01/10/2015: 1. Diagnosis of current major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), as assessed in the Structured Clinical Interview for DSM Disorders (SCID-I). 2. Hamilton Depression Rating Scale (HDRS) total score >14 3. Aged 18-65 4. Outpatient 5. Sufficient knowledge of the Dutch language 6. Dominance of either dependent or self-critical personality characteristics (prototype matching procedure by Werbart and Forsström: At least a score of 3/5 for one of the patterns and a minimum of 2 points difference with the score on the other personality pattern) 7. Patients on antidepressant medication can still meet inclusion criteria and can participate in the study if they are on a stable dose for at least four weeks. All medication use will be registered in detail throughout the procedure. Previous inclusion criteria: 1. Diagnosed with major depressive disorder, according to the description in DSM-V 2. Aged >18 years old 3. Living in the Ghent region 4. Outpatient 5. Dutch speaking
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/10/2015: 1. Manifest psychotic symptoms or bipolar disorder 2. Acute suicidal risk 3. Current substance abuse /dependence (SCID) 4. Evidence of cognitive impairment that might prevent full participation in the treatments 5. Evidence of serious physical illness that strongly affects the depression or is causal for the depression 6. Other ongoing psychotherapeutic treatments Previous exclusion criteria: 1. Acute psychotic episode 2. Acute suicidal tendency 3. Manifest substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 01/10/2015: Baseline and post-treatment severity of depression symptoms is derived by the Dutch version of the Hamilton Rating Scale for Depression (HDRS). Two external raters are trained to reach adequate interrater-reliability. The raters are blind to the research hypotheses, the research design, and the conditions to which the patients were assigned. The HDRS is rated on semi-structured pre- and post interviews (adjusted SCID-I for baseline severity and HDRS interview for post-treatment severity; see above and below) that are rated in random order, in order to avoid expectancy biases. Previous primary outcome measures: The Beck Depression Inventory-II, Dutch version (BDI-II-NL) is a symptom-specific questionnaire with 21 self-rated items, which indicates the severity of symptom of Major Depressive Disorder. It will be administered pre-treatment and post-treatment, at sessions 4, 8, 12, and 16 during treatment, and at 3-month, 6-month, 12-month and 24-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/10/2015: 1. The Beck Depression Inventory-II, Dutch version (BDI-II-NL) is a symptom-specific questionnaire with 21 self-rated items, which indicates the severity of symptoms of Major Depressive Disorder. It will be administered pre-treatment and post-treatment, at sessions 4, 8, 12, and 16 during treatment, and at 3-month, 6-month, 12-month and 24-month follow-up. 2. The Inventory of Interpersonal Problems-32 (IIP-32) is a self-rated questionnaire with 32 items that indicates the most salient interpersonal problems. It is administered pre-treatment and posttreatment, at sessions 4, 8, 12, and 16 during treatment, and at 3-month, 6-month, 12-month and 24-month follow-up. 3. The Symptom Checklist-90-Revised (SCL-90-R) is a self-rated questionnaire with 90 items that indicates a range of psychopathology symptoms. It is administered pre-treatment and post-treatment, at sessions 4, 8, 12, and 16 during treatment, and at 3-month, 6-month, 12-month and 24-month follow-up. 4. Outcome Questionnaire-45 (OQ-45) is a self-rated questionnaire with 45 items that indicates general wellbeing. It is administered pre-treatment and post-treatment, at sessions 4, 8, 12, and 16 during treatment, and at 3-month, 6-month, 12-month and 24-month follow-up. 5. The shortened Depression Anxiety and Stress Scale (DASS) is a 21-item self-report questionnaire on the presence and severity of symptoms of depression, anxiety and stress. It is administered pretreatment and post-treatment, at every session of the treatment process, and at 3-month, 6-month, 12-month and 24-month follow-up. 6. Cortisol stress levels are analyzed as indicators of stress, by means of mass spectrometry of saliva and hair samples. The saliva samples are gathered for four consecutive days (one sample early morning and one late evening every day) at pre-treatment and post-treatment, at sessions 4, 8, 12, and 16 during treatment, and at 3-month, 6-month, 12-month and 24-month follow | — |
Countries
Belgium
Contacts
Public ContactMattias Desmet
Outcome results
None listed