Psychoeducational Videos and Digital Assessments for BPD

Borderline Personality Disorder Clinical Trial

Official title:

Online Psychoeducational Videos and Digital Assessments as a Method for Broadening Access to Care for Borderline Personality Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358925
• Other study ID #: 2022P000892
• Secondary ID: 30053
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: Study Coordinator
• Phone: 617-855-2738
• Email: gundersonpdi[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

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 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.
• 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 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.
• 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, coping, self-compassion and self-care, stress and anxiety, depression, and healthy sleep habits.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline (day 1), Follow-Up (day 60)
Other	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)
Other	Hospitalization Check-In	Number of patients who have been hospitalized.	Time 2 (day 15) and Time 3 (day 30)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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: 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.	Daily, days 1-30
Other	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)
Other	Client Satisfaction Questionnaire (CSQ-8)	Acceptability measure.	Time 2 (day 15)
Primary	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)
Secondary	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)