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Real-time Experiences With Sleep Training Study

Real-time Experiences With Sleep Training Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04507308
Acronym
REST
Enrollment
57
Registered
2020-08-11
Start date
2024-06-01
Completion date
2026-06-21
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder, Sleep Disturbance

Keywords

ecological momentary assessment, electroencephalogram, Transdiagnostic Sleep and Circadian Intervention Youth

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 (TSC-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 Salt Lake City community, via chart review, 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 TSC-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 (TSC-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 = 57); 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=57) will participate with a parent. Recruitment will be conducted through chart review at the Huntsman Mental Health Institute, physician and therapist referrals, and ethics-approved media advertisements and fliers. Interested participants (and a parent) will complete a brief telephone or Zoom 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 2. At visit 1, perform consent/assent and sign forms via electronic signature on REDCap; see "Parental Permission and Authorization Document" and "Assent") Virtual Visit 1 via Zoom * Pre-visit risk assessment with youth (UWRAP) * Interviews: * The Childhood Interview for Borderline Personality Disorder * Lifetime Suicide Attempt Self-Injury Interview (L-SASII) * Means-End Problem-Solving Task (MEPS) * Schedule Sleep Band pick-up-participants to pick up on campus or coordinate other arrangements, as needed (e.g., mail). * End-of-visit risk assessment with youth 4\. Baseline Questionnaires: * Send parents and youth measures via email for electronic completion on REDCap: 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: * 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) * Participants receive/pick-up sleep band \ * Provide psychoeducation and instructions on wearing sleep band and completing EMA protocol * Schedule visit 2 (intervention visit) 5\. Ecological momentary assessment (EMA) and EEG Protocol 1 (10 days): * EMA assessments are collected 5 times per day. Upon waking, participants report bed time and wake time for calibration with sleep EEG data * Each daily survey assesses 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 monitor EMA responses each day. * When responses during the EMA protocol indicate imminent risk of suicide or self-injury, 988 and SafeUT contact information automatically display on participants' smart phone, and research staff immediately receive an automated e-mail. Research staff are able to log into REDCap to view participants' responses, and may contact the participant by text or 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 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 DCFS. 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\. \ 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 or Dr. Kaufman completed the following handouts from the TSC Youth protocol (an established, evidence-based sleep intervention for adolescents) in collaboration with the participant and their parent: * "Functional Analysis" * "Improving Your Sleep Summary" * "My Sleep Goals" * "Rise-up checklist" * "Wind-down handout" * "Stimulus Control" * 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 \ 3-to-4-week period where youth implement and get accustomed to their new sleep plan \ 8\. Sleep headband band pick-up (on campus) 9\. Post-EMA and EEG Protocol 2 (10 days; 3-4 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 monitored EMA responses daily for compliance and safety as described above. 10\. Sleep headband drop-off (on campus) 11\. Post-test Questionnaires: * Send parents and youth measures via email for electronic completion on REDCap: 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.\ 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. * 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

Interventions

BEHAVIORALSingle-session sleep intervention drawn from principles of the TSC-youth protocol

We are providing participants psychoeducation on sleep and will be going over several handouts from the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TSC-Youth) to improve sleep.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

All participants are completing the same study procedure.

Intervention model description

All participants are completing the same study procedure.

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep improvementBaseline 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.Change from baseline sleep data (self- and informant-report, electroencephalogram data during sleep, and ecological momentary assessment data) to post-intervention data.
Change in borderline personality disorder symptomsBaseline 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.Change in participants' BPD symptoms from baseline (assessed via diagnostic interview and a 10-day ecological momentary assessment protocol) to one-month post-intervention (via a second 10-day ecological momentary assessment protocol).

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORErin A Kaufman, Ph.D.

University of Utah

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026