depression melancholy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. DSM diagnosis of major depression b. Eligible patients who are on antidepressants and who are willing to discontinue their medications during treatment, prior to participation, will be eligible to participate in the study. Patients already on antidepressants who wish to continue medication are also eligible, but only if their medication use is stable for at least three months before start of treatment
Exclusion criteria
Exclusion criteria: a. severe mental illness (e.g. schizophrenia) b. high risk for suicide c. drug and/or alcohol dependence d. a primary diagnosis other than MDD e. a cluster A or B personality disorder diagnosis f. prior psychotherapy in the previous year g. no access to internet facilities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression (BDI-II) and quality of life (EQ-5D (5L)) will be the main outcome measures over the course of two years. Besides the completion of a clinical interview at baseline, patients will complete monthly assessments during the first six months of the study. There will be follow-up assessments 9, 12 and 24 months after start of treatment. For the patients who are willing to participate, blood samples will be collected during baseline and end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary study parameters will be involved in the study: Therapeutic alliance (Working Alliance Inventory), cognitive skills (Competencies of Cognitive Therapy Scale/Performance of CT Strategies ), interpersonal skills, recall (patients recall of the last session rated by the therapist), motivation for therapy (Autonomous and Controlled Motivation for Treatment Questionnaire), compliance (amount of no-show and rated by patient and therapist), emotion regulation (Action Control Scale), executive functioning (n-back task), automatic thoughts (Cognition Checklist ), behavioral activation (Behavioral Activation for Depression Scale) and biological factors (brain-derived neurotrophic factor (BDNF), DNA methylation of CpG islands adjacent to promoters I and IV) and oxytocin. | — |
Countries
Netherlands