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| ID | Type | Description | Link |
|---|---|---|---|
| 30053 | Other Grant/Funding Number | Brain and Behavior Research Foundation |
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| Name | Class |
|---|---|
| Brain & Behavior Research Foundation | OTHER |
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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.
In this study, 100 adults who were diagnosed with BPD within the past three months will be randomly assigned to receive psychoeducational videos (4-10 minutes each) about the development, symptoms, naturalistic trajectory, and treatment of BPD (2/3 of participants) or matched-length videos about non-BPD, health-related topics (1/3 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) and Digit Symbol Matching Test, 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPD Videos and Feedback | Experimental | Ten daily 4-10 minute psychoeducational videos about BPD and personalized feedback about performance on neuropsychological tasks. |
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| BPD Videos and No Feedback | Experimental | Ten daily 4-10 minute psychoeducational videos about BPD. |
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| Non-BPD Videos and No Feedback | Sham Comparator | Ten daily 4-10 minute educational videos about health-related topics other than BPD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducational Videos | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Borderline Symptom List 23 (BSL-23) | 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. | Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 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. | Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment History Questionnaire | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lois W Choi-Kain, MD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38060545 | Derived | Choi-Kain LW, Murray GE, Jurist J, Ren B, Germine L. Online psychoeducation and digital assessments as a first step of treatment for borderline personality disorder: A protocol for a pilot randomized controlled trial. PLoS One. 2023 Dec 7;18(12):e0294331. doi: 10.1371/journal.pone.0294331. eCollection 2023. |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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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), 2/3 of participants will be directed to the BPD-video condition, and 1/3 to the non-BPD-video condition. Only the participants in the BPD-video condition will be randomized to receive feedback or not (1/2 each condition). No non-BPD-video participants will receive feedback.
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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.
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| Neuropsychological Feedback | Other | 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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| Non-BPD-related Educational Videos | Other | 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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| Baseline (day 1), Follow-Up (day 60) |
| BPD Knowledge Assessment | 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. | Baseline (day 1), Time 2 (day 15), Follow-Up (day 60) |
| Hospitalization Check-In | Number of patients who have been hospitalized. | Time 2 (day 15) and Time 3 (day 30) |
| McLean Assessment of Rejection Sensitivity (MARS) | 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. | Baseline (day 1), Follow-Up (day 60) |
| 3-Item Loneliness Scale (LS-3) | 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. | Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) |
| San Diego Wisdom Scale (SD-WISE) | 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. | Baseline (day 1), Follow-Up (day 60) |
| Level of Personality Functioning Scale (LPFS) | 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. | Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60) |
| Continuous Performance Test (Full-Length Version) | 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) |
| Read the Mind in the Eyes Task (RMET). Minimum score = 0, maximum score = 37. Higher score indicates greater accuracy in identifying facial emotion expressions. | Change (increase or decrease) in RMET score and sub-scores at time 2, time 3, and follow-up, as compared to baseline. | Baseline (day 1), Follow-Up (day 60) |
| Belmont Emotion Sensitivity Test (BEST) | 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. | Baseline (day 1), Follow-Up (day 60) |
| Digit Span Test (DST) | 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) |
| Daily Ecological Momentary Assessment (EMA) Measures | Trends over time of scores/ratings on all EMA questions and the 1-minute version of the CPT. The EMA Measures include:
| Daily, days 1-30 |
| Digit Symbol Matching Test (DSMT) | 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. | Baseline (day 1), daily days 1-30, Time 3 (day 30), Follow-Up (day 60) |
| Client Satisfaction Questionnaire (CSQ-8) | Acceptability measure. | Time 2 (day 15) |