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Clinical Trials in Belgium / NCT04337242
Active, not recruiting Not applicable

Blended Care Versus Face-to-Face Therapy for Depression

NCT04337242 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Not applicable
Started
2019-03-29
Last updated
2024-12-05

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

B-DITB-CBTDITCognitive Behavioral Therapy

B-DIT: Blended Dynamic Interpersonal Therapy

B-CBT: Blended Cognitive Behavioral Therapy

DIT: Dynamic Interpersonal Therapy

Cognitive Behavioral Therapy: CBT

Study 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, 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II) at 6-month follow-up (12 months after the start of treatment) — From baseline to 6 months follow-up (12 months after the start of treatment)
    Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)

Trial sites (6)

FacilityCityRegionStatus
CGG Andante Berchem Belgium
CGG Vagga Berchem Belgium
CGG Mandel & Leie Kortrijk Belgium
CGG VBO Leuven Belgium
CGG De Pont Mechelen Belgium
CGG Kempen Turnhout Belgium

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Other trials for the same condition

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) Recruiting
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) Recruiting
INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04337242 on ClinicalTrials.gov ↗ ← All trials in Belgium