Frequency and change mechanisms of psychotherapy among depressed patients: a multicenter randomized trial.

Conditions: depression
melancholy
10027946

Registration Number: NL-OMON44191

Lead Sponsor: Vrije Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 230

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Depression (BDI-II) and quality of life (EQ-5D (5L)) will be the main outcome<br /><br>measures over the course of two years. Besides the completion of a clinical<br /><br>interview at baseline, patients will complete monthly assessments during the<br /><br>first six months of the study. There will be follow-up assessments 9, 12 and<br /><br>24 months after start of treatment. For the patients who are willing to<br /><br>participate, blood samples will be collected during baseline and end of<br /><br>treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following secondary study parameters will be involved in the study:<br /><br><br /><br>Therapeutic alliance (Working Alliance Inventory), cognitive skills<br /><br>(Competencies of Cognitive Therapy Scale/Performance of CT Strategies ),<br /><br>interpersonal skills, recall (patients recall of the last session rated by the<br /><br>therapist), motivation for therapy (Autonomous and Controlled Motivation for<br /><br>Treatment Questionnaire), compliance (amount of no-show and rated by patient<br /><br>and therapist), emotion regulation (Action Control Scale), executive<br /><br>functioning (n-back task), automatic thoughts (Cognition Checklist ),<br /><br>behavioral activation (Behavioral Activation for Depression Scale) and<br /><br>biological factors (brain-derived neurotrophic factor (BDNF), DNA methylation<br /><br>of CpG islands adjacent to promoters I and IV) and oxytocin.</p><br>