Clinical Trial

B-DIT Feasibility Study

Study acronym: B-DIT
Active, Not Recruiting
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Record status
This record was last updated September 11, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. Blended interventions have the potential to improve treatment accessibility and cost-effectiveness for individuals with personality pathology and promote a sense of agency and ownership among clients regarding their treatment as compared to traditional Face-to-Face (FTF) approaches. This may improve treatment outcome and recovery. The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp, integrates FTF therapy and online modules into a cohesive treatment program. The program spans three phases: an individual phase lasting approximately two months, followed by a four-month group phase, and concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases. The primary study aims are (1) to monitor and evaluate the feasibility of B-DIT; which includes evaluating client satisfaction, treatment drop-out rates, user parameters related to online modules, and an interview-based qualitative analysis of therapists' and clients' experiences; and (2) to gather initial effectiveness data based on Routine Outcome Monitoring (ROM) measurements, complemented by a Single Case Experimental Design (SCED). The research questions are as follows: 1. How acceptable is the blended treatment program, B-DIT, for adult clients with personality pathology and their therapists? 2. What is the effectiveness of B-DIT for adult clients with personality pathology in terms of progress in reducing symptom burden, overall functioning, and personality functioning, including changes in process measures such as mentalizing ability, epistemic trust, and agency? 3. Exploratively, the effects on these process and outcome measures across treatment phases will be compared to ascertain if observed changes align with the presumed working mechanisms of the intervention.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-17; most recent amendment 2025-09-04.
Status change: Recruiting → Active, Not Recruiting 2025-09-04
Status change: Not Yet Recruiting → Recruiting 2024-06-24
Trial Details
NCT Number NCT06471010
Lead Sponsor De Viersprong
Collaborators: Stichting tot Steun, OnlinePsyhulp
Conditions Personality Disorders
Enrollment 27 participants
Start Date 2024-06-17
Primary Completion 2026-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-11