B-DIT Feasibility Study

NCT06471010 | Active Not Recruiting

• 1 other identifier: 2024-0085
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 1.How acceptable is the blended treatment program, B-DIT, for adult clients with personality pathology and their therapists?
2. 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. 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.

Conditions

Personality Disorders

Keywords

Blended treatment; E-health; Psychotherapy; Personality disorder; Personality pathology; Treatment accessibility

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Agency

  From baseline, throughout the intervention, to 12 months after end of treatment

• Epistemic Trust

  From baseline, throughout the intervention, to 12 months after end of treatment

• Reflective Functioning

  From baseline, throughout the intervention, to 12 months after end of treatment

• Treatment expectations

  Baseline - after indication for treatment; End of treatment (end of phase C)

• Experiences of clients and clinicians

  End of phase C (booster phase)

Study Arms (1)

B-DIT

Other: Blended Dynamic Interpersonal Therapy (B-DIT)

Interventions

Blended Dynamic Interpersonal Therapy (B-DIT) OTHER

The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp (http://www.onlinepsyhulp.be), integrates FTF therapy and online modules into a cohesive treatment program for clients with personality pathology. Both FTF and online treatment components are anchored in the Dynamic Interpersonal Therapy (DIT) framework (Lemma et al., 2011).The program spans three phases: an individual phase lasting approximately two months, followed by a five-month group phase, 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. Both verbal psychotherapy and art therapy are offered as treatment modalities in the face-to-face treatment sessions. The program is implemented by a multidisciplinary team.

B-DIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clients referred to De Viersprong are eligible for B-DIT when they exhibit mild to moderately severe impairments in personality functioning (including both cluster B, C, or a mixed presentation within unspecified personality disorder). Clients typically present with persistent problems in specific areas of their functioning, and typically have had previous, unsuccessful treatments. Adequate functioning in at least one domain of life (such as family, work, other societal roles) should be ensured, which allows for the generalization of treatment gains during and after the relatively short-term/ low intensity intervention. All patients that are referred to B-DIT at de Viersprong are eligible for the study.

You may qualify if:

• years of age or older
• mild to moderately severe impairments in personality functioning, including both cluster B and cluster C personality problems as well as a mixed presentation within unspecified personality disorder.

You may not qualify if:

• insufficient proficiency in the Dutch language
• no permanent place of residence
• intellectual disability (IQ \< 80)
• organic brain disorder
• autism spectrum disorders
• schizophrenia or schizophreniform disorder
• (untreated) eating disorder, extreme obesity, or a BMI \< 17.5
• (untreated) addiction.
• acute risk of crisis requiring stabilizing/crisis interventions
• Severe PTSD or the severe range of personality problems (structural: low-level borderline organization).

Sponsors & Collaborators

• De Viersprong: lead
• Stichting tot Steun: collaborator
• OnlinePsyhulp: collaborator

Study Sites (1)

De Viersprong

Halsteren, North Brabant, 4660AA, Netherlands

Location

Related Publications (1)

• Lemma A, Target M, Fonagy P. The development of a brief psychodynamic intervention (dynamic interpersonal therapy) and its application to depression: a pilot study. Psychiatry. 2011 Spring;74(1):41-8. doi: 10.1521/psyc.2011.74.1.41.

  PMID: 21463169 BACKGROUND

Related Links

• Website of OnlinePsyHulp that developed and facilitates the online treatment modules

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Maaike L Smits, Dr.

  De Viersprong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 24, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)