Real-time Experiences With Sleep Training Study

NCT04507308 | Completed DMC

• 1 other identifier: 115454
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder; Sleep Disturbance

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sleep improvement

  Change from baseline sleep data (self- and informant-report, electroencephalogram data during sleep, and ecological momentary assessment data) to post-intervention data.

  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.

• Change in borderline personality disorder symptoms

  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).

  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.

Study Arms (1)

Transdiagnostic Sleep and Circadian Intervention

EXPERIMENTAL

All participants will undergo baseline assessment and then complete a brief, single-session sleep-focused intervention based on psychoeduation and handouts from the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TranS-C-Youth).

Behavioral: Single-session sleep intervention drawn from principles of the TranS-C youth protocol

Interventions

Single-session sleep intervention drawn from principles of the TranS-C youth protocol BEHAVIORAL

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 (TranS-C-Youth) to improve sleep.

Transdiagnostic Sleep and Circadian Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth between 13 and 18 years of age
• + 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

University of Western Ontario Westminster Hall

London, Ontario, N6G 2M1, Canada

Location

Related Publications (23)

• American Psychiatric Association, & American Psychiatric Association. DSM-5 Task Force. (2013). Diagnostic and statistical manual of mental disorders: DSM-5. (Fifth edition.). Washington, DC: American Psychiatric Association.

  BACKGROUND

• Kaess M, Brunner R, Chanen A. Borderline personality disorder in adolescence. Pediatrics. 2014 Oct;134(4):782-93. doi: 10.1542/peds.2013-3677. Epub 2014 Sep 22.

  PMID: 25246626 BACKGROUND

• Zimmerman M, Chelminski I, Young D, Dalrymple K, Martinez J. Is dimensional scoring of borderline personality disorder important only for subthreshold levels of severity? J Pers Disord. 2013 Apr;27(2):244-51. doi: 10.1521/pedi.2013.27.2.244.

  PMID: 23514187 BACKGROUND

• Soloff PH, Lis JA, Kelly T, Cornelius J, Ulrich R. Risk factors for suicidal behavior in borderline personality disorder. Am J Psychiatry. 1994 Sep;151(9):1316-23. doi: 10.1176/ajp.151.9.1316.

  PMID: 8067487 BACKGROUND

• Zanarini MC, Frankenburg FR, Hennen J, Reich DB, Silk KR. The McLean Study of Adult Development (MSAD): overview and implications of the first six years of prospective follow-up. J Pers Disord. 2005 Oct;19(5):505-23. doi: 10.1521/pedi.2005.19.5.505.

  PMID: 16274279 BACKGROUND

• Linehan, M. M. (1993). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press.

  BACKGROUND

• Winsper C, Tang NK, Marwaha S, Lereya ST, Gibbs M, Thompson A, Singh SP. The sleep phenotype of Borderline Personality Disorder: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2017 Feb;73:48-67. doi: 10.1016/j.neubiorev.2016.12.008. Epub 2016 Dec 15.

  PMID: 27988314 BACKGROUND

• Bastien CH, Guimond S, St-Jean G, Lemelin S. Signs of insomnia in borderline personality disorder individuals. J Clin Sleep Med. 2008 Oct 15;4(5):462-70.

  PMID: 18853705 BACKGROUND

• Benson KL, King R, Gordon D, Silva JA, Zarcone VP Jr. Sleep patterns in borderline personality disorder. J Affect Disord. 1990 Apr;18(4):267-73. doi: 10.1016/0165-0327(90)90078-m.

  PMID: 2140379 BACKGROUND

• Plante DT, Frankenburg FR, Fitzmaurice GM, Zanarini MC. Relationship between sleep disturbance and recovery in patients with borderline personality disorder. J Psychosom Res. 2013 Apr;74(4):278-82. doi: 10.1016/j.jpsychores.2013.01.006. Epub 2013 Feb 11.

  PMID: 23497827 BACKGROUND

• Selby, E.A., Ribeiro, J.D., Joiner Jr., T.E. (2013). What dreams may come: Emotional cascades and nightmares in borderline personality disorder. Dreaming, 23, 126.

  BACKGROUND

• Balestrieri M, Rucci P, Sbrana A, Ravani L, Benvenuti A, Gonnelli C, Dell'osso L, Cassano GB. Lifetime rhythmicity and mania as correlates of suicidal ideation and attempts in mood disorders. Compr Psychiatry. 2006 Sep-Oct;47(5):334-41. doi: 10.1016/j.comppsych.2006.01.004. Epub 2006 Apr 21.

  PMID: 16905394 BACKGROUND

• Winsper C, Tang NK. Linkages between insomnia and suicidality: prospective associations, high-risk subgroups and possible psychological mechanisms. Int Rev Psychiatry. 2014 Apr;26(2):189-204. doi: 10.3109/09540261.2014.881330.

  PMID: 24892894 BACKGROUND

• Semiz UB, Basoglu C, Ebrinc S, Cetin M. Nightmare disorder, dream anxiety, and subjective sleep quality in patients with borderline personality disorder. Psychiatry Clin Neurosci. 2008 Feb;62(1):48-55. doi: 10.1111/j.1440-1819.2007.01789.x.

  PMID: 18289141 BACKGROUND

• Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. doi: 10.1016/j.smrv.2005.11.001. Epub 2006 Mar 24.

  PMID: 16564189 BACKGROUND

• Essner B, Noel M, Myrvik M, Palermo T. Examination of the Factor Structure of the Adolescent Sleep-Wake Scale (ASWS). Behav Sleep Med. 2015;13(4):296-307. doi: 10.1080/15402002.2014.896253. Epub 2014 Apr 17.

  PMID: 24742264 BACKGROUND

• LeBourgeois MK, Giannotti F, Cortesi F, Wolfson AR, Harsh J. The relationship between reported sleep quality and sleep hygiene in Italian and American adolescents. Pediatrics. 2005 Jan;115(1 Suppl):257-65. doi: 10.1542/peds.2004-0815H.

  PMID: 15866860 BACKGROUND

• Harvey, A.G., 2015. A transdiagnostic intervention for youth sleep and circadian problems. Cognitive and Behavioral Practice, 3, 341-355.

  BACKGROUND

• Bastida-Pozuelo MF, Sanchez-Ortuno MM, Meltzer LJ. Nurse-led brief sleep education intervention aimed at parents of school-aged children with neurodevelopmental and mental health disorders: Results from a pilot study. J Spec Pediatr Nurs. 2018 Oct;23(4):e12228. doi: 10.1111/jspn.12228. Epub 2018 Nov 27.

  PMID: 30480370 BACKGROUND

• Ellis JG, Cushing T, Germain A. Treating Acute Insomnia: A Randomized Controlled Trial of a "Single-Shot" of Cognitive Behavioral Therapy for Insomnia. Sleep. 2015 Jun 1;38(6):971-8. doi: 10.5665/sleep.4752.

  PMID: 25515106 BACKGROUND

• Husky M, Olie E, Guillaume S, Genty C, Swendsen J, Courtet P. Feasibility and validity of ecological momentary assessment in the investigation of suicide risk. Psychiatry Res. 2014 Dec 15;220(1-2):564-70. doi: 10.1016/j.psychres.2014.08.019. Epub 2014 Aug 15.

  PMID: 25155939 BACKGROUND

• Jahng S, Wood PK, Trull TJ. Analysis of affective instability in ecological momentary assessment: Indices using successive difference and group comparison via multilevel modeling. Psychol Methods. 2008 Dec;13(4):354-75. doi: 10.1037/a0014173.

  PMID: 19071999 BACKGROUND

• Trull TJ, Solhan MB, Tragesser SL, Jahng S, Wood PK, Piasecki TM, Watson D. Affective instability: measuring a core feature of borderline personality disorder with ecological momentary assessment. J Abnorm Psychol. 2008 Aug;117(3):647-61. doi: 10.1037/a0012532.

  PMID: 18729616 BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Erin A Kaufman, Ph.D.

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants are completing the same study procedure.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: All participants are completing the same study procedure.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: November 17, 2020
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Each of the above supporting information may be provided following the end of the study and publication of primary findings. Directly or indirectly identifiable data will be destroyed after 7 years (consistent with University of Western Ontario's policy). All other data will be available for 25 years.
• Access Criteria: Interested researchers can email the principle investigator to request de-identified data. They will be asked to provide a plan for data security.

Locations

CA (1)