Clinical trial NCT04507308: Real-time Experiences With Sleep Training Study
Official title: Real-time Experiences With Sleep Training Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Sleep Disturbance
Keywords: ecological momentary assessment
electroencephalogram
Transdiagnostic Sleep and Circadian Intervention Youth
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants are completing the same study procedure.
Primary purpose: TREATMENT

Brief summary: Borderline personality disorder (BPD) is a serious mental illness that often first emerges in adolescence. Effective treatments are typically expensive, lengthy, and intense (e.g., Dialectical Behavior Therapy). Thus, setting individuals up for treatment success is extremely important. Disrupted sleep is closely linked to many BPD symptoms (e.g., moodiness, impulsivity, interpersonal problems), and people with BPD have a range of sleep-related problems. Importantly, sleep problems may make BPD symptoms worse, longer lasting, and also interfere with learning new skills in treatment. Understanding sleep problems in BPD may help create better interventions, as most therapies for BPD do not currently address sleep difficulties. Although approaches like Cognitive Behaviour Therapy for insomnia (CBT-I) and the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TranS-C-Youth) work well with many populations, scientists don't yet know if youth with BPD features can tolerate a sleep-focused intervention. The investigators will recruit youth between ages 13 and 18 who have 3 or more clinically impairing BPD symptoms from the London community and via clinician referrals. They will also recruit a parent to report on their child's sleep patterns, mental health symptoms, and accompany youth to an intervention session. Participants will complete diagnostic interviews and a range of surveys to assess their current functioning (e.g., sleep, mental health, BPD symptoms). Investigators will also ask youth to report on their BPD symptoms multiple times per day in real time and track their sleep at night for a 10-day period. Participants will also wear a headband to track their brain waves while they sleep. After an initial 10-day monitoring period, youth participants will receive a brief, single-session sleep intervention with their parent using materials from the TranS-C-Youth protocol. Adolescents will be asked to follow a sleep plan created during their visit for three weeks before completing another 10 days of assessment. Participants will complete a follow-up survey battery upon completion of the second real-time survey protocol, and also be invited to complete surveys one-month post intervention. The investigators hypothesize that day-to-day variability in sleep will influence BPD symptom presentation, and vice versa. They also hypothesize that our intervention will improve sleep quantity/quality among an at-risk sample, and may be associated with decreased BPD symptoms relative to baseline.

Detailed 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 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:

1. 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
2. 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.
3. 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)
4. 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 \~
5. 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).
6. Call participant to schedule sleep band drop-off (on campus)

   \~ Participant returns sleep band \~
7. 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 \~
8. Call participant to schedule second sleep band pick-up (on campus)

   \~ Participants receive/pick-up sleep band (pick-up within 1 week of call) \~
9. 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.
10. 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.\~
11. Call participant to schedule sleep band drop-off (on campus) Participant drops-off sleep band
12. Payment given for EMA electronically (emailed) after sleep band is returned undamaged
13. 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

Eligibility criteria: Inclusion Criteria:

* Youth between 13 and 18 years of age
* 3+ clinically impairing symptoms of borderline personality disorder as determined via screening interview
* Parent available to complete informant-report and accompany participant to sleep intervention session
* Participant has a cellular phone or reliable access to a computer to complete ecological momentary assessment protocol

Exclusion Criteria:

* Participants without English language proficiency will be excluded as the study requires verbal and written components delivered exclusively in English.
* Participants with fewer than 3 clinically impairing BPD symptoms will be excluded from the study.
* We will exclude adolescents who present with an intellectual disability or have a schizophrenia spectrum diagnosis.
* Participants who do not have a parent/caregiver available to attend the virtual intervention session will also be excluded from the study.
* Participants without access to a personal cellular phone or reliable access to a computer with internet will be excluded.

Primary outcomes:
measure: Sleep improvement
timeFrame: Baseline data will be collected over the course of a 10 day period (including ecological momentary assessment data) and compared to data collected over a second 10 day window one-month post intervention.
measure: Change in borderline personality disorder symptoms
timeFrame: Baseline data will be collected over the course of a 10 day period (including ecological momentary assessment data) and compared to data collected over a second 10 day window one-month post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario Westminster Hall
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Erin A Kaufman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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