NCT04337242Active, not recruiting
Blended Care Versus Face-to-Face Therapy for Depression
Blended Care Psychodynamic Therapy or Cognitive Behavioral Therapy Versus Face-to-Face Psychotherapy for Depression: A Pragmatic Multicenter Randomized Controlled Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
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, waiting lists for psychotherapy are typically very long. To help resolve this problem, this study aims to investigate whether blended therapies, i.e. therapies that consist of a mixture of face-to-face sessions and online sessions, are (cost-)effective as a treatment for depression, and whether they are as (cost-)effective as traditional treatments which consist of face-to-face sessions alone. Should this be the case, then blended therapy can be implemented on a large scale in mental health care, as it could provide a more cost-effective means of helping individuals with depression. This study also aims to investigate whether certain patient features, such as the severity of depression and personality traits, may influence the efficacy of (blended) psychotherapy for depression. Finally, we will also investigate patients' attitudes towards and experience of blended therapy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 504 (estimated)
- First submitted
- 11 Feb 2020
- Start date
- Mar 2019
- Primary completion date
- Dec 2024
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Depression
- NCT number
- NCT04337242
What you commit to
- Study type: Interventional
- Planned participants: 504
- From Mar 2019 to the primary completion date, Dec 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current excessive use of drugs/alcohol.
- Participation in another depression clinical trial within the last year where the participant has received CBT or PDT.
Other illness
- 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).
Other
- Historic or current self-injury/parasuicide of such extent and/or severity that may substantially interfere with the ability to engage in brief psychotherapy.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CGG Vagga Coordinator of this site? Confirm its status | Berchem | Belgium | Unknown status |
| CGG Andante Coordinator of this site? Confirm its status | Berchem | Belgium | Unknown status |
| CGG Mandel & Leie Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| CGG VBO Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CGG De Pont Coordinator of this site? Confirm its status | Mechelen | Belgium | Unknown status |
| CGG Kempen Coordinator of this site? Confirm its status | Turnhout | Belgium | Unknown status |
Related publications
- Clinical and Cost-Effectiveness of Blended Cognitive Behavioral Therapy or Psychodynamic Therapy Versus Face-to-Face Psychotherapy for Depression (BLENDED Study): Protocol for a Pragmatic, Multicenter, Assessor-Blinded Randomized Controlled Noninferiority Trial.JMIR Res Protoc · 2026 · PMID 41533960
This page is information, not medical advice. Discuss any trial with your doctor.