Clinical trial NCT05358925: Psychoeducational Videos and Digital Assessments for BPD
Official title: Online Psychoeducational Videos and Digital Assessments as a Method for Broadening Access to Care for Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
ecological momentary assessment
psychoeducation
neuropsychological feedback
symptom tracking
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2022-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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), 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.
Primary purpose: TREATMENT

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.

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 (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.

Eligibility 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 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).

Primary outcomes:
measure: Borderline Symptom List 23 (BSL-23)
timeFrame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
Other outcomes:
measure: Treatment History Questionnaire
timeFrame: Baseline (day 1), Follow-Up (day 60)
measure: BPD Knowledge Assessment
timeFrame: Baseline (day 1), Time 2 (day 15), Follow-Up (day 60)
measure: Hospitalization Check-In
timeFrame: Time 2 (day 15) and Time 3 (day 30)
measure: McLean Assessment of Rejection Sensitivity (MARS)
timeFrame: Baseline (day 1), Follow-Up (day 60)
measure: 3-Item Loneliness Scale (LS-3)
timeFrame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
measure: San Diego Wisdom Scale (SD-WISE)
timeFrame: Baseline (day 1), Follow-Up (day 60)
measure: Level of Personality Functioning Scale (LPFS)
timeFrame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
measure: Continuous Performance Test (Full-Length Version)
timeFrame: Baseline (day 1), Time 3 (day 30), Follow-Up (day 60)
measure: Read the Mind in the Eyes Task (RMET). Minimum score = 0, maximum score = 37. Higher score indicates greater accuracy in identifying facial emotion expressions.
timeFrame: Baseline (day 1), Follow-Up (day 60)
measure: Belmont Emotion Sensitivity Test (BEST)
timeFrame: Baseline (day 1), Follow-Up (day 60)
measure: Digit Span Test (DST)
timeFrame: Baseline (day 1), Time 2 (day 15), Time 3 (day 30), Follow-Up (day 60)
measure: Daily Ecological Momentary Assessment (EMA) Measures
timeFrame: Daily, days 1-30
measure: Digit Symbol Matching Test (DSMT)
timeFrame: Baseline (day 1), daily days 1-30, Time 3 (day 30), Follow-Up (day 60)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Time 2 (day 15)
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Lois W Choi-Kain, MD
role: PRINCIPAL_INVESTIGATOR
References: