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Frequency and change mechanisms of psychotherapy for depression.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28796
Enrollment
230
Registered
2014-10-21
Start date
2014-10-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ENGLISH: frequency

Interventions

Cognitive therapy includes psycho-education (explanation of the treatment rationale and the general procedures in CBT treatment), behavioral activation (motivating the patient to build a day structure

Sponsors

VU Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. DSM V diagnosis of major depression (DSM V persistent depressive disorder will be included) 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

MeasureTime 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. At 24 months, the LIFE interview will be administered to assess the presence of depressive episodes in the previous year. For the patients who are willing to participate, blood samples will be collected during baseline and end of treatment.

Secondary

MeasureTime 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.

Contacts

Public ContactS. Bruijniks

PhD Student VU University Amsterdam Department of Clinical Psychology Van der Boechorststraat 1

s.j.e.bruijniks@vu.nl+3120-5988497

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)