Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Borderline Personality Disorder
  • Sleep Disturbance
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All participants are completing the same study procedure.Masking: None (Open Label)Masking Description: All participants are completing the same study procedure.Primary Purpose: Treatment

Participation Requirements

Age
Between 13 years and 18 years
Gender
Both males and females

Description

Borderline personality disorder (BPD) is a persistent and profoundly impairing mental disorder characterized by interpersonal turmoil, severe emotion dysregulation, and impulsivity(1). BPD often first manifests in adolescence(2) and even subthreshold levels of symptoms are associated with significan...

Borderline personality disorder (BPD) is a persistent and profoundly impairing mental disorder characterized by interpersonal turmoil, severe emotion dysregulation, and impulsivity(1). BPD often first manifests in adolescence(2) and even subthreshold levels of symptoms are associated with significant psychosocial morbidity(3). Approximately 69% to 80% of persons with this condition engage in self-injurious behavior, and as many as 9% die by suicide(4-5). Although efficacious treatment approaches have been developed (e.g., Dialectical Behavior Therapy [DBT];6), they are typically expensive, lengthy, and intensive. Identifying methods for optimizing BPD treatment and prevention is an urgent public health priority. Disrupted sleep is closely linked to defining characteristics of BPD such as higher sensitivity and reactivity to stress, behavioral impulsivity, interpersonal dysfunction, and poor emotion regulation(7). Studies have documented a range of sleep disturbances among BPD samples, and demonstrated that sleep problems are not better accounted for by concomitant depression or other psychiatric disorders(7-9). Importantly, sleep problems may worsen BPD symptom course and chronicity(10-11), heighten risk of suicide(12-13) and self-harm(14), and interfere with cognitive processes that are vital to behavioral intervention (e.g., memory consolidation, and attentional processes; 15). A greater understanding of sleep disturbance in BPD may help enrich treatment protocols, which currently place limited emphasis on sleep difficulties(11). Although approaches like Cognitive Behaviour Therapy for insomnia (CBT-I) and the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TranS-C-Youth) are effective with many populations(16), it is currently unknown whether sleep-focused interventions can be tolerated or followed adherently by youth with BPD features (who are often extremely dysregulated across affective, interpersonal, and behavioral domains). Objectives: 1) To assess transactional relations of sleep, interpersonal stressors, affect, impulsive behaviors, and self-harm among youth with BPD features (N = 50); 2) To assess the effects of a brief sleep intervention on subsequent sleep quality (primary outcome) and BPD symptoms (secondary outcome). This pilot study will establish recruitment feasibility, determine the acceptability and efficacy of a sleep-focused intervention among adolescents with BPD features, and provide crucial preliminary data to support future grants. Methodology. The investigators will use a pre-post intervention design with 2 assessments. Changes in BPD symptoms, self-reported sleep quality, and ambulatory monitoring of electroencephalogram (EEG) during sleep, will be assessed approximately 30 days post-treatment. Two 10-day EMA protocols (one prospective and one post-intervention) will provide data for transactional analyses. Participants: Adolescents ages 13-18 (N=50) will participate with a parent. Recruitment will be conducted through physician and therapist referrals and ethics-approved media advertisements and fliers posted in waiting rooms where youth with BPD are likely to be treated (e.g., children's hospital), and common community venues (coffee shops, libraries, community centers). Interested participants (and a parent) will complete a brief telephone screen to determine initial eligibility and schedule two virtual visits. Research Protocol: Phone Screening/Eligibility: Parental verbal consent for phone screen and Youth verbal assent for phone screen Brief interview to determine eligibility: McLean Screening Interview Schedule virtual visit 1 via Zoom over phone, or during email follow-up Send consent/assent documents via email (forms sent for electronic signature; see "Parental Permission and Authorization Document" and "Assent") Consent forms are signed/returned electronically. Baseline Questionnaires: - Send parents and youth measures via email for electronic completion: Youth questionnaires: Demographic Questionnaire The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) Adolescent Sleep Hygiene Scale Borderline Personality Features Scale for Children-11(BPFS-C-11) PROMIS Pediatric Sleep Disturbances SF8 PROMIS Pediatric Sleep Related Impairment SF8 Self-Concept and Identity Measure (SCIM) Adolescent Sleep Wake Scale - 10 item version Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale Short form (UPPS-P) Items from the Sleep Practices and Attitudes Questionnaire Parent-Report (can be completed online post-visit if needed): Demographic Questionnaire PROMIS Pediatric Sleep Disturbances Parent Proxy SF8 PROMIS Pediatric Sleep Practices Parent Proxy Sleep Disturbance Scale for Children PROMIS Pediatric Sleep Related Impairment Parent Proxy SF4 Child Behavior Checklist (CBCL) Virtual Visit 1 via Zoom Pre-visit risk assessment with youth Interviews: The Childhood Interview for Borderline Personality Disorder Lifetime Suicide Attempt Self-Injury Interview (L-SASSI) Schedule Sleep Band pick-up over the phone-participants to pick up on campus or coordinate other arrangements, as needed (e.g., mail). Provide psychoeducation and instructions on wearing sleep band and completing EMA protocol End-of-visit risk assessment with youth Participants receive/pick-up sleep band ~ Ecological momentary assessment (EMA) and EEG Protocol 1 (10 days): EMA assessments will be collected 5 times per day. Upon waking, participants will report bed time and wake time for calibration with sleep EEG data Each daily survey will assess current mood, sleep, and BPD symptoms since the last prompt (e.g., perceived emotional control/dyscontrol, emotional lability, interpersonal conflict, impulsive behavior, dissociation, self-harm urges/behaviors; see attached EMA protocol). Research staff will monitor EMA responses each morning. When responses during the EMA protocol indicate imminent risk of suicide or self-injury (see EMA protocol for specific rules), the CMHA Ontario's suicide crisis number will automatically display on participants' smart phone, and research staff will immediately receive an automated e-mail. Research staff are able to log into the secure database to view participants' responses, and Dr. Kaufman may contact the participant by telephone for risk assessment and safety planning. Appropriate intervention or follow-up care will be arranged. In cases of immediate safety risk, the research team will define a feasible safety plan with the participant (this may include other members in the participants' network and/or crisis intervention services and emergency care). If child abuse or neglect is disclosed, the alleged abuse will be reported to local child welfare services and provincial/territorial social service ministries. During the consent process, all participants will be informed of limits to confidentiality and our legal obligations to report dangerous situations. EMA protocols of similar duration and assessment frequency have been successfully conducted with individuals at risk for self-harm with excellent participant compliance rates (21-23). Call participant to schedule sleep band drop-off (on campus) ~ Participant returns sleep band ~ Virtual visit 2 via Zoom Pre-visit risk assessment Together, youth and parent watch a video providing psychoeducation about sleep Youth will receive a sleep-focused skills training session with their parent: ~A clinical psychology graduate student will complete the following handouts from the TranS-C Youth protocol (an established, evidence-based sleep intervention for adolescents) in collaboration with the participant and their parent: "Case Conceptualization" "Improving Your Sleep Summary" "Rise-up checklist" "Wind-down handout" "Stimulus Control" "My Sleep Goals" Participants will be asked to practice the skills they have learned for the following month and be provided digital copies of their worksheets to support their unique sleep plan. End-of-visit risk assessment 2-week period where youth implement and get accustomed to their new sleep plan ~ Call participant to schedule second sleep band pick-up (on campus) ~ Participants receive/pick-up sleep band (pick-up within 1 week of call) ~ Post-EMA and EEG Protocol 2 (10 days; 3 weeks post-intervention) - EMA assessments will proceed as they did for protocol 1 (i.e., 5 times per day), with additional prompts to assess sleep plan/skill usage. Research staff will monitor EMA responses by examining data each morning. When responses during the EMA protocol indicate imminent risk of suicide or self-injury, the CMHA Ontario's suicide crisis number will automatically display on participants' smart phone, and research staff will immediately receive an automated e-mail. Research staff are able to log into the secure database to view participants' responses, and Dr. Kaufman may contact the participant by telephone for risk assessment and safety planning. Appropriate intervention or follow-up care will be arranged. In cases of immediate safety risk, the research team will define a feasible safety plan that includes other members in the participants' network and/or crisis intervention services and emergency care. If child abuse or neglect is disclosed, the alleged abuse will be reported to local child welfare services and provincial/territorial social service ministries. During the consent process, all participants will be informed of limits to confidentiality and our legal obligations to report dangerous situations. Post-test Questionnaires: - Send parents and youth measures via email for electronic completion: Youth: DERS-SF Adolescent Sleep Hygiene Scale BPFS-C-11 PROMIS Pediatric Sleep Disturbances SF8 PROMIS Pediatric Sleep Related Impairment SF8 SCIM Adolescent Sleep Wake Scale - 10 item version UPPS-P Items from the Sleep Practices and Attitudes Questionnaire Parents: PROMIS Pediatric Sleep Disturbances Parent Proxy SF8 PROMIS Pediatric Sleep Practices Parent Proxy Sleep Disturbance Scale for Children PROMIS Pediatric Sleep Related Impairment Parent Proxy SF4 ~Questionnaires need to be completed no later than 1 week after 2nd EMA protocol.~ Call participant to schedule sleep band drop-off (on campus) Participant drops-off sleep band Payment given for EMA electronically (emailed) after sleep band is returned undamaged 1-Month Follow-up Participants will be emailed questionnaires 1-month following completion of their second EMA protocol. Those who complete these questionnaires will be entered to win a drawing for a $50 gift card (one for parents and one for teens) Youth emailed: DERS-SF Adolescent Sleep Hygiene Scale BPFS-C-11 PROMIS Pediatric Sleep Disturbances SF8 PROMIS Pediatric Sleep Related Impairment SF8 SCIM Adolescent Sleep Wake Scale - 10 item version Parents emailed: PROMIS Pediatric Sleep Disturbances Parent Proxy SF8 PROMIS Pediatric Sleep Practices Parent Proxy Sleep Disturbance Scale for Children PROMIS Pediatric Sleep Related Impairment Parent Proxy SF4

Tracking Information

NCT #
NCT04507308
Collaborators
Not Provided
Investigators
Principal Investigator: Erin A Kaufman, Ph.D. University of Western Ontario, Canada