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Psychoeducational Videos and Digital Assessments for BPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05358925
Recruitment Status : Not yet recruiting
First Posted : May 3, 2022
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Lois W. Choi-Kain, MD, Mclean Hospital

Brief Summary:
In this study, 100 adults who were recently diagnosed with borderline personality disorder (BPD) will be randomized to either receive educational videos about BPD or educational videos about other topics. All participants in both conditions will complete daily surveys about their emotions and social interactions, and they will respond to surveys and complete cognitive tests at 4 different time points. Some participants will receive feedback about their cognitive test performance, and others will not. The investigators are interested in learning about how accurate education about BPD and enhanced knowledge about cognitive abilities might help people manage their BPD symptoms. The investigators expect that participants who received psychoeducation about BPD will have lower levels of BPD and depressive symptoms than other participants, and that participants who received feedback on their cognitive tests will also have lower symptoms.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Other: Psychoeducational Videos Other: Neuropsychological Feedback Other: Non-BPD-related Educational Videos Not Applicable

Detailed Description:
In this study, 100 adults who were diagnosed with BPD within the past three months will be randomly assigned to receive psychoeducational videos (12 minutes each) about the development, symptoms, naturalistic trajectory, and treatment of BPD (75% of participants) or matched-length videos about non-BPD, health-related topics (25% of participants). One video will be delivered every business day for two weeks. Participants will respond to 5-minute surveys on their recent social interactions, their feelings of threat, connectedness, and aloneness, and will complete a 1-minute version of the Continuous Performance Test (CPT), every day for 30 days. Participants will complete additional full-length surveys and cognitive tests at 4 time points: baseline (Day 1), Time 2 (day 15), Time 3 (Day 30), and Follow-up (day 60). The primary outcome is BPD symptom severity, and the secondary outcome is depressive symptom severity. The investigators expect that BPD-focused psychoeducation and personalized neuropsychological feedback will each lead to separate, measurable reductions in BPD and depressive symptom severity. The investigators also expect that the relationship between psychoeducation and symptom reduction will be mediated by increased knowledge about BPD, and that the relationship between neuropsychological feedback and symptom reduction will be mediated by increased cognitive control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This study includes two randomization branching points: (1) BPD-related videos vs. non-BPD-related videos, and (2) receive neuropsychological feedback vs. not. At branching point (1), 75% of participants will be directed to the BPD-video condition, and 25% to the non-BPD-video condition. Only the participants in the BPD-video condition will be randomized to receive feedback or not (50% each condition). No non-BPD-video participants will receive feedback.
Masking: None (Open Label)
Masking Description:

While the investigators will not explicitly inform participants of their condition, it will be apparent based on the content of the videos they receive and whether or not they receive feedback.

The investigators and study staff will be aware of condition assignments in order to facilitate the delivery of the appropriate videos and the neuropsychological feedback.

Primary Purpose: Treatment
Official Title: Online Psychoeducational Videos and Digital Assessments as a Method for Broadening Access to Care for Borderline Personality Disorder
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BPD Videos and Feedback
Ten daily 12-minute psychoeducational videos about BPD and personalized feedback about performance on neuropsychological tasks.
Other: Psychoeducational Videos

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 10-12 minutes long, for a total of ~120 minutes of video. Videos will be shared via a hyperlink in a text message.

The psychoeducational videos will cover the following topics: the history of the diagnosis of BPD and current diagnostic criteria, challenging BPD-related stigma, developmental pathways to BPD and biological predisposition, prevalence of BPD and its common comorbid disorders, the naturalistic course of BPD without treatment, available psychotherapeutic treatment options for BPD, current research on the neurobiological and genetic markers related to BPD, the interpersonal hypersensitivity model of BPD, lifestyle changes that are beneficial for people with BPD


Other: Neuropsychological Feedback
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 all 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.

Experimental: BPD Videos and No Feedback
Ten daily 12-minute psychoeducational videos about BPD.
Other: Psychoeducational Videos

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 10-12 minutes long, for a total of ~120 minutes of video. Videos will be shared via a hyperlink in a text message.

The psychoeducational videos will cover the following topics: the history of the diagnosis of BPD and current diagnostic criteria, challenging BPD-related stigma, developmental pathways to BPD and biological predisposition, prevalence of BPD and its common comorbid disorders, the naturalistic course of BPD without treatment, available psychotherapeutic treatment options for BPD, current research on the neurobiological and genetic markers related to BPD, the interpersonal hypersensitivity model of BPD, lifestyle changes that are beneficial for people with BPD


Sham Comparator: Non-BPD Videos and No Feedback
Ten daily 12-minute educational videos about health-related topics other than BPD.
Other: Non-BPD-related Educational Videos
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, lifestyle changes to combat stress, what is psychotherapy?, prevalence of depression and anxiety in the general population, healthy sleep habits.




Primary Outcome Measures :
  1. Borderline Symptom List 23 (BSL-23) [ Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) ]
    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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) ]
    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.


Other Outcome Measures:
  1. Treatment History Questionnaire [ Time Frame: Baseline (day 1), Follow-Up (day 60) ]

    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.


  2. BPD Knowledge Assessment [ Time Frame: Baseline (day 1), Time 2 (day 15), Follow-Up (day 60) ]
    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.

  3. Hospitalization Check-In [ Time Frame: Time 2 (day 15) and Time 3 (day 30) ]
    Number of patients who have been hospitalized.

  4. McLean Assessment of Rejection Sensitivity (MARS) [ Time Frame: Baseline (day 1), Follow-Up (day 60) ]
    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.

  5. 3-Item Loneliness Scale (LS-3) [ Time Frame: Baseline (day 1), Follow-Up (day 60) ]
    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.

  6. San Diego Wisdom Scale (SD-WISE) [ Time Frame: Baseline (day 1), Follow-Up (day 60) ]
    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.

  7. Level of Personality Functioning Scale (LPFS) [ Time Frame: Baseline (day 1), Follow-Up (day 60) ]
    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.

  8. Continuous Performance Test (Full-Length Version) [ Time Frame: Baseline (day 1), Follow-Up (day 60) ]

    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.


  9. 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), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) ]
    Change (increase or decrease) in RMET score and sub-scores at time 2, time 3, and follow-up, as compared to baseline.

  10. Belmont Emotion Sensitivity Test (BEST) [ Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) ]
    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.

  11. Digit Span Test (DST) [ Time Frame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) ]

    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.


  12. Daily Ecological Momentary Assessment (EMA) Measures [ Time Frame: Daily, days 1-30 ]

    Trends over time of scores/ratings on all EMA questions and the 1-minute version of the CPT.

    The EMA Measures include:

    • General Functioning: "Did you attend work/school today?" (yes/no) A higher number of days attending work/school indicates better functioning.
    • Social Functioning (# of social interactions since last assessment): Minimum value = 0, no maximum value. A higher number indicates a more active social life.
    • Psychological & Interpersonal States: 14 individual questions, each rated from 0-2. Questions are considered individually, rather than combined into summary scores. A higher score indicates that the participant identifies more strongly with the psychological/interpersonal state (e.g., "I feel securely connected to at least one person I care about." or "I am on alert for signs of rejection.")
    • CPT (1-minute version): The minimum and maximum scores and interpretation of the 1-minute CPT are the same as the full-length version listed above.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 3 months
  • awake and able to complete EMA surveys between 9:00am and 9:00pm on most days
  • located within Massachusetts.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05358925


Contacts
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Contact: Study Coordinator 617-855-2738 gundersonpdi@partners.org

Sponsors and Collaborators
Mclean Hospital
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Lois W Choi-Kain, MD Mclean Hospital
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Responsible Party: Lois W. Choi-Kain, MD, Director, Gunderson Personality Disorder; Assistant Professor of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT05358925    
Other Study ID Numbers: 2022P000892
30053 ( Other Grant/Funding Number: Brain and Behavior Research Foundation )
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lois W. Choi-Kain, MD, Mclean Hospital:
borderline personality disorder
ecological momentary assessment
psychoeducation
neuropsychological feedback
symptom tracking
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders