Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471010
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-12
Brief Title:
B-DIT Feasibility Study
Sponsor:
De Viersprong
Organization:
De Viersprong
Study Overview
Official Title:
Feasibility and Preliminary Effectiveness of Blended Dynamic Interpersonal Psychotherapy for Personality Pathology
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-DIT
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 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
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
Detailed Description:
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 B-DIT integrates face-to-face FTF therapy and online modules into a cohesive treatment program offering potential advantages in terms of treatment accessibility and cost-effectiveness for individuals with personality pathology Additionally blended interventions may have added value compared to traditional FTF approaches by fostering a greater sense of agency and ownership among clients regarding their treatment While e-health and blended interventions have demonstrated promising treatment outcomes across various mental health areas there is limited evidence for interventions targeting personality pathology
B-DIT developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp addresses this gap and provides a blended intervention for clients with mild to moderately severe personality pathology 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 conducting a 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 SCED allows drawing conclusions about effectiveness based on a relatively small sample while accommodating potential refinements to the intervention during the study period The following research questions will be addressed
1 How acceptable is a blended treatment program Dynamic Interpersonal Therapy B-DIT for adult clients with personality pathology and for their therapists
2 How effective is B-DIT for adult clients with personality pathology in terms of progress in improving symptom burden overall functioning and personality functioning along with changes in process measures mentalizing ability epistemic trust agency
3 Exploratively the effects on these process and outcome measures across treatment phases will be compared to determine if observed changes are consistent with the presumed working mechanisms of the intervention
Participants in the study will receive care as usual In complement to regular Routine Outcome Monitoring assessments as integrated part of treatment participants will be asked to complete an additional 26-item questionnaire repeatedly during their treatment and over a one year follow-up period in a Single Case Experimental Design with four phases
Phase A - Baseline Waiting List before start of treatment - with a minimum of 3 weeks Phase B - Intensive treatment phase 10 weeks of individual treatment followed by 30 weeks of group treatment - 30 weeks Phase C - Booster treatment phase - 16 weeks Phase D - Follow-up phase after the end of treatment - 12 months
The impact of expectations with regards to their treatment will be assessed at baseline and at end of treatment Clients and clinicians will be questioned about their experiences in the treatment program at the end of treatment by means of semi-structured qualitative interviews
B-DIT developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp addresses this gap and provides a blended intervention for clients with mild to moderately severe personality pathology 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 conducting a 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 SCED allows drawing conclusions about effectiveness based on a relatively small sample while accommodating potential refinements to the intervention during the study period The following research questions will be addressed
1 How acceptable is a blended treatment program Dynamic Interpersonal Therapy B-DIT for adult clients with personality pathology and for their therapists
2 How effective is B-DIT for adult clients with personality pathology in terms of progress in improving symptom burden overall functioning and personality functioning along with changes in process measures mentalizing ability epistemic trust agency
3 Exploratively the effects on these process and outcome measures across treatment phases will be compared to determine if observed changes are consistent with the presumed working mechanisms of the intervention
Participants in the study will receive care as usual In complement to regular Routine Outcome Monitoring assessments as integrated part of treatment participants will be asked to complete an additional 26-item questionnaire repeatedly during their treatment and over a one year follow-up period in a Single Case Experimental Design with four phases
Phase A - Baseline Waiting List before start of treatment - with a minimum of 3 weeks Phase B - Intensive treatment phase 10 weeks of individual treatment followed by 30 weeks of group treatment - 30 weeks Phase C - Booster treatment phase - 16 weeks Phase D - Follow-up phase after the end of treatment - 12 months
The impact of expectations with regards to their treatment will be assessed at baseline and at end of treatment Clients and clinicians will be questioned about their experiences in the treatment program at the end of treatment by means of semi-structured qualitative interviews
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None