Status:
ACTIVE_NOT_RECRUITING
Blended Care Versus Face-to-Face Therapy for Depression
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Belgium Health Care Knowledge Centre
Erasmus University Rotterdam
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Depression is a severe mental disorder that affects 5-7% of Belgians each year. Unfortunately, many individuals with depression do not seek professional help, and if they do seek professional help, wa...
Detailed Description
Depression is a highly prevalent disorder with a lifetime prevalence of 15-25%, and is associated with high psychosocial and economic costs (e.g, suicide, absenteeism, long-term disability). Epidemiol...
Eligibility Criteria
Inclusion
- Age 18-65
- Current diagnosis of major depressive disorder with or without dysthymic disorder according to DSM 5 criteria.
- PHQ score ≥ 10.
- Note: Use of pharmacotherapy for depression and other psychiatric disorders during the intervention is allowed (with the exception of antipsychotic medication for psychotic disorder), as this reflects routine clinical care. Of note, in routine clinical care, it is not uncommon that antipsychotic medication is prescribed for symptoms in the depressive-anxious cluster rather than for primary psychotic symptoms.
Exclusion
- Current psychotic symptoms or bipolar disorder.
- Current use of antipsychotic medication specifically for the treatment of primary psychotic disorder.
- Severe Personality Disorder (e.g., borderline personality disorder).
- Historic or current self-injury/parasuicide of such extent and/or severity that may substantially interfere with the ability to engage in brief psychotherapy.
- Current excessive use of drugs/alcohol.
- Not fluent in Dutch.
- Clinical contra-indication to brief psychotherapy (e.g., attachment history - multiple separations, serious ongoing trauma in childhood, multiple caregivers - suggesting the need for longer-term psychotherapy).
- Evidence of pervasive use of help.
- Highly unstable or insecure life arrangements.
- No access to computer/internet or computer illiteracy.
- Participation in another depression clinical trial within the last year where the participant has received CBT or PDT.
Key Trial Info
Start Date :
March 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT04337242
Start Date
March 29 2019
End Date
September 30 2026
Last Update
December 5 2024
Active Locations (6)
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1
CGG Andante
Berchem, Belgium, 2600
2
CGG Vagga
Berchem, Belgium, 2600
3
CGG Mandel & Leie
Kortrijk, Belgium, 8500
4
CGG VBO
Leuven, Belgium, 3000