- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05358925
Psychoeducational Videos and Digital Assessments for BPD
Online Psychoeducational Videos and Digital Assessments as a Method for Broadening Access to Care for Borderline Personality Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Study Coordinator
- Phone Number: 617-855-2738
- Email: gundersonpdi@partners.org
Study Locations
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- Recruiting
- Mclean Hospital
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Contact:
- Lois W Choi-Kain, MD
- Phone Number: 617-855-3933
- Email: lchoikain@mgb.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- reliable access to a smartphone with a data plan for the duration of the study
- ability to speak and understand English
- age 18 years or older
- diagnosis of BPD within the past 6 months
- awake and able to complete EMA surveys between 9:00am and 9:00pm on most days
- located within the United States
Exclusion Criteria:
- cognitive disability that impedes ability to participate in the study
- current psychiatric symptoms that interfere with the individual's ability to provide consent or complete the research procedures (e.g., acute mania, acute psychosis, eating disorder threatening medical stability).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BPD Videos and Feedback
Ten daily 4-10 minute psychoeducational videos about BPD and personalized feedback about performance on neuropsychological tasks.
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A total of ten videos will be delivered daily Monday-Friday over approximately 2 weeks (days 1-15). The videos will each feature a mental health professional who is an expert in BPD explaining the topic in relatable language that can be understood by the general public. Each video will be approximately 4-10 minutes long, for a total of ~72 minutes of video. Videos will be shared via a hyperlink in a text message. The psychoeducational videos will cover the following topics: symptoms, basic factors about BPD, the naturalistic long term course of BPD, prevalence of BPD and its common comorbid disorders, key principles for recovery, available psychotherapeutic treatment options for BPD, common factors amongst treatments, medications, the interpersonal hypersensitivity model of BPD, and a review of the top 10 tips.
In the second phase of the study, participants randomized to the Feedback condition will receive an email with a personalized summary of their symptom endorsement and neuropsychological performance.
The feedback will include the relevant scores or sub-scores for each cognitive test (CPT, RMET, BEST, DST) from the first two time points.
For each score and sub-score, there will be a description of the cognitive domain that the metric assesses (e.g., attention span in the CPT).
The investigators will tailor the feedback to each participant's scores.
The investigators may adjust the format or wording of the feedback based on participant responses (i.e., if a participant alerts the investigators that some wording is unclear or confusing).
The investigators may also alter the feedback if they learn new information about the relevance or interpretability of these cognitive tests, as this is a growing field of research.
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Experimental: BPD Videos and No Feedback
Ten daily 4-10 minute psychoeducational videos about BPD.
|
A total of ten videos will be delivered daily Monday-Friday over approximately 2 weeks (days 1-15). The videos will each feature a mental health professional who is an expert in BPD explaining the topic in relatable language that can be understood by the general public. Each video will be approximately 4-10 minutes long, for a total of ~72 minutes of video. Videos will be shared via a hyperlink in a text message. The psychoeducational videos will cover the following topics: symptoms, basic factors about BPD, the naturalistic long term course of BPD, prevalence of BPD and its common comorbid disorders, key principles for recovery, available psychotherapeutic treatment options for BPD, common factors amongst treatments, medications, the interpersonal hypersensitivity model of BPD, and a review of the top 10 tips. |
Sham Comparator: Non-BPD Videos and No Feedback
Ten daily 4-10 minute educational videos about health-related topics other than BPD.
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The non-BPD-related educational videos will be matched in length and frequency to the BPD-related videos.
These videos will discuss aspects of mental and physical health that are not related to BPD.
Examples may include: nutrition and healthy eating, coping, self-compassion and self-care, stress and anxiety, depression, and healthy sleep habits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Borderline Symptom List 23 (BSL-23)
Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Change (increase or decrease) in BSL-23 mean score (average score across all 23 items) at time 2, time 3, and follow-up, as compared to baseline.
Minimum score = 0, maximum score = 4.
A higher score indicates more severe BPD symptoms.
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Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Change (increase or decrease) in PHQ-9 total score at time 2, time 3, and follow-up, as compared to baseline.
Minimum score = 0, maximum score = 27.
A higher score indicates more severe depressive symptoms.
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Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment History Questionnaire
Time Frame: Baseline (day 1), Follow-Up (day 60)
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Change between baseline and follow-up on the following metrics: A) Amount of treatment received in each of the following categories: individual therapy (# appointments per week for X weeks), group therapy (# months in group), day treatment (# days in program). B) Number of past psychiatric hospitalizations. C) History of BPD-specialized psychotherapy (yes/no). The minimum value is 0 for all questions on this questionnaire (e.g., 0 past hospitalizations). There is no maximum value for any question. A higher level of past engagement with mental health services may indicate a history of more severe psychopathology, or may indicate a greater level of access to mental health services, or a combination of these factors. |
Baseline (day 1), Follow-Up (day 60)
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BPD Knowledge Assessment
Time Frame: Baseline (day 1), Time 2 (day 15), Follow-Up (day 60)
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Change (increase or decrease) in BPD Knowledge Assessment total score at time 2 and follow-up, as compared to baseline.
This instrument is currently in development.
A higher score will indicate a greater level of knowledge related to BPD.
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Baseline (day 1), Time 2 (day 15), Follow-Up (day 60)
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Hospitalization Check-In
Time Frame: Time 2 (day 15) and Time 3 (day 30)
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Number of patients who have been hospitalized.
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Time 2 (day 15) and Time 3 (day 30)
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McLean Assessment of Rejection Sensitivity (MARS)
Time Frame: Baseline (day 1), Follow-Up (day 60)
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Change (increase or decrease) in MARS total score between baseline and follow-up.
Minimum score = 11, maximum score = 55.
A higher score indicates a greater sensitivity to rejection.
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Baseline (day 1), Follow-Up (day 60)
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San Diego Wisdom Scale (SD-WISE)
Time Frame: Baseline (day 1), Follow-Up (day 60)
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Change (increase or decrease) in SD-WISE total score and sub-scores (Acceptance of Divergent Perspectives, Decisiveness, Emotional Regulation, Pro-Social Behaviors, Self-Reflection, Social Advising, and Spirituality) between baseline and follow-up.
For the total score and all sub-scores, the minimum score = 1, maximum score = 5.
A higher score indicates a better outcome.
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Baseline (day 1), Follow-Up (day 60)
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Digit Span Test (DST)
Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Change (increase or decrease) in DST total score and sub-scores (Digits Forward and Digits Backward) at time 2, time 3, and follow-up, as compared to baseline. The DST total score has a minimum of 0 and a maximum of 30. The Digits Forward sub-score has a minimum of 0 and a maximum of 16. The Digits Backward sub-score has a minimum of 0 and a maximum of 14. A higher total score indicates greater memory and attention ability. A higher Digits Forward score primarily indicates greater attention/concentration. A higher Digits Backward score primarily indicates better working memory. |
Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Daily Ecological Momentary Assessment (EMA) Measures
Time Frame: Daily, days 1-30
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Trends over time of scores/ratings on all EMA questions and the 1-minute version of the CPT. The EMA Measures include:
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Daily, days 1-30
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3-Item Loneliness Scale (LS-3)
Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Change (increase or decrease) in LS-3 total score between baseline and follow-up.
Minimum score = 3, maximum score = 9.
A higher score indicates more frequent feelings of loneliness.
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Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Level of Personality Functioning Scale (LPFS)
Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Change (increase or decrease) in LPFS total score between baseline and follow-up.
Minimum score = 12, maximum score = 48.
A higher score indicates more severe impairment in personality functioning.
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Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
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Continuous Performance Test (Full-Length Version)
Time Frame: Baseline (day 1), Time 3 (day 30), Follow-Up (day 60)
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Change (increase or decrease) in CPT scores (Detectability, Omissions, Commissions, Perseverations) between baseline and follow-up. CPT scores are calculated as T-Scores (minimum=0, maximum=100). Higher Commission and Perseveration scores indicate a higher level of impulsivity. Higher Detectability, Omission, and Commission scores indicate a higher level of inattentiveness. |
Baseline (day 1), Time 3 (day 30), Follow-Up (day 60)
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Read the Mind in the Eyes Task (RMET). Minimum score = 0, maximum score = 37. Higher score indicates greater accuracy in identifying facial emotion expressions.
Time Frame: Baseline (day 1), Follow-Up (day 60)
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Change (increase or decrease) in RMET score and sub-scores at time 2, time 3, and follow-up, as compared to baseline.
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Baseline (day 1), Follow-Up (day 60)
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Belmont Emotion Sensitivity Test (BEST)
Time Frame: Baseline (day 1), Follow-Up (day 60)
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Change (increase or decrease) in BEST score for each condition (Happiness, Fear, Anger) at time 2, time 3, and follow-up, as compared to baseline.
For each condition, minimum score = 0, maximum score = 56.
A higher score indicates greater accuracy in differentiating facial emotion expressions.
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Baseline (day 1), Follow-Up (day 60)
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Digit Symbol Matching Test (DSMT)
Time Frame: Baseline (day 1), daily days 1-30, Time 3 (day 30), Follow-Up (day 60)
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Changes (increase or decrease) and trends in DSMT score at time 3 and follow up as compared to baseline, and across the 30 days of EMA.
The score indicates processing speed.
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Baseline (day 1), daily days 1-30, Time 3 (day 30), Follow-Up (day 60)
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Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Time 2 (day 15)
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Acceptability measure.
|
Time 2 (day 15)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lois W Choi-Kain, MD, Mclean Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022P000892
- 30053 (Other Grant/Funding Number: Brain and Behavior Research Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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