B-DIT Feasibility Study
NCT Number: NCT06471010
Acronym: B-DIT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Personality Disorders
Interventions: OTHER: Blended Dynamic Interpersonal Therapy (B-DIT)
Sponsor: De Viersprong
Collaborators: Stichting tot Steun|OnlinePsyhulp
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2025-12
Locations: De Viersprong, Halsteren, Noord-Brabant, 4660AA, Netherlands

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.

Primary Outcome Measures: Personality functioning- Severity Indices of Personality Functioning, Personality functioning- Severity Indices of Personality Functioning (SIPP-60): a 60-item self-report ROM questionnaire

Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up), From baseline, throughout the intervention, to 12 months after end of treatment|Personality functioning- Level of Personality Functioning, Personality functioning - Level of Personality Functioning Brief-Form 2.0 (LBFS-BF-2.0): a 12-item self-report ROM questionnaire.

Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up)., From baseline, throughout the intervention, to 12 months after end of treatment|Symptom distress, Brief Symptom Inventory (BSI): a 53-item self-report ROM questionnaire.

Administered as part of Routine Outcome Monitoring at start of intervention and subsequently every treatment evaluation (at 12, 20 and 30 weeks after start of the intervention); at the end of treatment; and at two follow-up timepoints after the end of treatment (6 and 12 months follow-up), From baseline, throughout the intervention, to 12 months after end of treatment|Overall functioning, Outcome Rating Scale (ORS): a 4-item self-report questionnaire.

Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED. During:

* Phase A: weekly during the baseline waiting period with a minimum of three weeks.
* Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
* Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
* Phase D: two-monthly during the follow-up phase of 12 months, From baseline, throughout the intervention, to 12 months after end of treatment|Usability of the online portal, System Usability Scale (SUS): a 10-item self-report questionnaire, End of treatment (end of phase C)
Secondary Outcome Measures: Agency, General Self-Efficacy Scale (GSES): a 10 item self-report questionnaire

Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED.

* Phase A: weekly during the baseline waiting period with a minimum of three weeks.
* Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
* Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
* Phase D: two-monthly during the follow-up phase of 12 months, From baseline, throughout the intervention, to 12 months after end of treatment|Epistemic Trust, 4 selected items of the Questionnaire Epistemic Trust (QET)

Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED.

* Phase A: weekly during the baseline waiting period with a minimum of three weeks.
* Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
* Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
* Phase D: two-monthly during the follow-up phase of 12 months, From baseline, throughout the intervention, to 12 months after end of treatment|Reflective Functioning, Reflective Functioning Questionnaire (RFQ): a 8 item self-report questionnaire.

Outcome measures of the Single Case Experimental Design are assessed using a composite questionnaire that is delivered to participants repeatedly in varying frequencies depending on the phase of treatment and respective phase of the SCED.

* Phase A: weekly during the baseline waiting period with a minimum of three weeks.
* Phase B: bi-weekly during the first intervention phase of 10 weeks individual treatment and second intervention phase of 20 weeks group treatment
* Phase C: monthly during the third intervention phase (booster phase) of 16 weeks
* Phase D: two-monthly during the follow-up phase of 12 months, From baseline, throughout the intervention, to 12 months after end of treatment|Treatment expectations, Credibility and Expectancy Questionnaire (CEQ), Baseline - after indication for treatment; End of treatment (end of phase C)|Experiences of clients and clinicians, Semi-structured interviews with clients and clinicians, End of phase C (booster phase)