Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality

NCT04316663 | Completed

• 1 other identifier: AAAS8486
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.

Conditions

Poor Quality Sleep

Keywords

Sleep Quality; Psychological Distress; Psychological Well-Being; Well-Being Therapy; Sleep Hygiene

Outcome Measures

Primary Outcomes (5)

• Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)

  Measured by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rating scale for the assessment of sleep quality over a 1-month time interval. The PSQI yields 7 component scores and one global score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is given a score from 0-3. The global score is calculated by summing the seven component scores, providing an overall score ranging from 0-21, where lower scores indicate a higher sleep quality.

  Baseline to immediate post-intervention

• Change in insomnia severity: Insomnia Severity Index (ISI)

  Measured by the Insomnia Severity Index (ISI), a 7-item self-rated questionnaire to measure insomnia severity in the past 2 weeks. The total score ranges from 0-28, with higher scores indicating greater severity of insomnia. Scores of 8-14, 15-21, and 22-28 are indicative of subthreshold, moderate, and severe clinical insomnia, respectively.

  Baseline to immediate post-intervention

• Changes in total sleep time

  Measured by self-reported sleep diary

  Baseline to immediate post-intervention

• Changes in sleep onset latency

  Measured by self-reported sleep diary

  Baseline to immediate post-intervention

• Changes in wake after sleep onset

  Measured by self-reported sleep diary

  Baseline to immediate post-intervention

Secondary Outcomes (2)

• Change in psychological distress

  Baseline to immediate post-intervention

• Change in psychological well-being

  Baseline to immediate post-intervention

Study Arms (2)

Well-Being and Sleep Hygiene

EXPERIMENTAL

Participants in the experimental group will receive an intervention focused on both principles of psychological well-being and sleep hygiene education.

Behavioral: Well-Being Intervention; Behavioral: Sleep Hygiene

Sleep Hygiene (Control)

ACTIVE COMPARATOR

Participants in the control group will receive sleep hygiene education alone.

Behavioral: Sleep Hygiene

Interventions

Well-Being Intervention BEHAVIORAL

The main aim of the well-being intervention is to reduce levels of distress through the promotion of psychological well-being. Key components of the intervention are self-monitoring of instances of well-being and what leads to their interruption (i.e., thoughts and behaviors), cognitive restructuring of interfering thoughts, and homework assignments to address dysfunctional behaviors and increase exposure to optimal experiences. Participants will become aware of their functioning based on six different dimensions of psychological well-being (i.e., self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth), and will be guided in finding a balance within each dimension.

Well-Being and Sleep Hygiene

Sleep Hygiene BEHAVIORAL

The main aim of sleep hygiene education is to provide participants with a set of behavioral and environmental recommendations intended to promote healthy sleep. During the intervention, participants will become aware of their own sleep patterns, will learn about healthy sleep habits, and will be encouraged to follow a set of recommendations to improve their sleep. Key components of the intervention are sleep hygiene and education.

Sleep Hygiene (Control); Well-Being and Sleep Hygiene

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Distress according to the Perceived Stress Scale
• Poor sleep quality according to the Pittsburgh Sleep Quality Index
• No diagnosis of sleep disorders
• English fluency
• Access to a computer with an Internet connection

You may not qualify if:

• Inability to provide informed consent for any reason
• Cognitive impairment according to the Montreal Cognitive Assessment
• Suspected presence of sleep apnea according to the Berlin Questionnaire
• Diagnosis of a chronic medical or psychiatric condition
• Severe depression or suicidal thoughts or wishes according to the Beck Depression Inventory
• Body Mass Index (BMI) ≥ 35 kg/m2
• Chronic use of medications for sleep or chronic medical and psychiatric conditions
• Any current psychological or behavioral intervention administered by a health care provider or as part of a research project
• Shift workers
• Pregnant women
• Parents or caregivers of newborns (\<1 year)
• Heavy drinkers (≥ 8 drinks/week for women and ≥ 15 drinks/week for men)
• Binge drinkers (≥ 4 drinks on a single occasion within about 2 hours for women and ≥ 5 drinks on a single occasion within about 2 hours for men
• Use of recreational or street drugs
• Heavy smokers (≥ 20 cigarettes daily)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (32)

• Almojali AI, Almalki SA, Alothman AS, Masuadi EM, Alaqeel MK. The prevalence and association of stress with sleep quality among medical students. J Epidemiol Glob Health. 2017 Sep;7(3):169-174. doi: 10.1016/j.jegh.2017.04.005. Epub 2017 May 5.

  PMID: 28756825 BACKGROUND

• Bao YP, Han Y, Ma J, Wang RJ, Shi L, Wang TY, He J, Yue JL, Shi J, Tang XD, Lu L. Cooccurrence and bidirectional prediction of sleep disturbances and depression in older adults: Meta-analysis and systematic review. Neurosci Biobehav Rev. 2017 Apr;75:257-273. doi: 10.1016/j.neubiorev.2017.01.032. Epub 2017 Feb 6.

  PMID: 28179129 BACKGROUND

• Bermudez-Millan A, Perez-Escamilla R, Segura-Perez S, Damio G, Chhabra J, Osborn CY, Wagner J. Psychological Distress Mediates the Association between Food Insecurity and Suboptimal Sleep Quality in Latinos with Type 2 Diabetes Mellitus. J Nutr. 2016 Oct;146(10):2051-2057. doi: 10.3945/jn.116.231365. Epub 2016 Aug 3.

  PMID: 27489004 BACKGROUND

• Benasi G, Guidi J, Rafanelli C, Fava GA. New applications of Well-Being Therapy. Rivista Sperimentale di Freniatria, 1:87-106, 2019

  BACKGROUND

• Buysse DJ. Sleep health: can we define it? Does it matter? Sleep. 2014 Jan 1;37(1):9-17. doi: 10.5665/sleep.3298.

  PMID: 24470692 BACKGROUND

• Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of prospective observational studies. Psychosom Med. 2008 Sep;70(7):741-56. doi: 10.1097/PSY.0b013e31818105ba. Epub 2008 Aug 25.

  PMID: 18725425 BACKGROUND

• Czeisler CA. Impact of sleepiness and sleep deficiency on public health--utility of biomarkers. J Clin Sleep Med. 2011 Oct 15;7(5 Suppl):S6-8. doi: 10.5664/JCSM.1340.

  PMID: 22003334 BACKGROUND

• Fava GA, Sonino N. Psychosomatic assessment. Psychother Psychosom. 2009;78(6):333-41. doi: 10.1159/000235736. Epub 2009 Aug 27.

  PMID: 19713727 BACKGROUND

• Fava GA. Well-Being Therapy treatment manual and clinical applications. Basel: Karger, 2016.

  BACKGROUND

• Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.

  PMID: 27043240 BACKGROUND

• Franzen PL, Buysse DJ. Sleep disturbances and depression: risk relationships for subsequent depression and therapeutic implications. Dialogues Clin Neurosci. 2008;10(4):473-81. doi: 10.31887/DCNS.2008.10.4/plfranzen.

  PMID: 19170404 BACKGROUND

• Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.

  PMID: 25454674 BACKGROUND

• Jahoda M. Current concepts of positive mental health. New York, NY, US: Basic Books, 1958.

  BACKGROUND

• Leger D, Poursain B, Neubauer D, Uchiyama M. An international survey of sleeping problems in the general population. Curr Med Res Opin. 2008 Jan;24(1):307-17. doi: 10.1185/030079907x253771.

  PMID: 18070379 BACKGROUND

• Lund HG, Reider BD, Whiting AB, Prichard JR. Sleep patterns and predictors of disturbed sleep in a large population of college students. J Adolesc Health. 2010 Feb;46(2):124-32. doi: 10.1016/j.jadohealth.2009.06.016. Epub 2009 Aug 3.

  PMID: 20113918 BACKGROUND

• Murawski B, Wade L, Plotnikoff RC, Lubans DR, Duncan MJ. A systematic review and meta-analysis of cognitive and behavioral interventions to improve sleep health in adults without sleep disorders. Sleep Med Rev. 2018 Aug;40:160-169. doi: 10.1016/j.smrv.2017.12.003. Epub 2017 Dec 29.

  PMID: 29397329 BACKGROUND

• Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.

  PMID: 12531146 BACKGROUND

• Ohayon MM, O'Hara R, Vitiello MV. Epidemiology of restless legs syndrome: a synthesis of the literature. Sleep Med Rev. 2012 Aug;16(4):283-95. doi: 10.1016/j.smrv.2011.05.002. Epub 2011 Jul 26.

  PMID: 21795081 BACKGROUND

• Pressman SD, Cohen S. Does positive affect influence health? Psychol Bull. 2005 Nov;131(6):925-971. doi: 10.1037/0033-2909.131.6.925.

  PMID: 16351329 BACKGROUND

• Rafanelli C, Park SK, Ruini C, Ottolini F, Cazzaro M, Fava GA. Rating wellbeing and distress. Stress & Health 16(1): 55-61, 2000.

  BACKGROUND

• Ryff CD. Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19.

  PMID: 24281296 BACKGROUND

• Seixas AA, Nunes JV, Airhihenbuwa CO, Williams NJ, Pandi-Perumal SR, James CC, Jean-Louis G. Linking emotional distress to unhealthy sleep duration: analysis of the 2009 National Health Interview Survey. Neuropsychiatr Dis Treat. 2015 Sep 25;11:2425-30. doi: 10.2147/NDT.S77909. eCollection 2015.

  PMID: 26442563 BACKGROUND

• Scott D, Paterson JL, Happell B. Poor sleep quality in Australian adults with comorbid psychological distress and physical illness. Behav Sleep Med. 2014;12(4):331-41. doi: 10.1080/15402002.2013.819469. Epub 2013 Nov 1.

  PMID: 24180418 BACKGROUND

• Tinetti ME, Bogardus ST Jr, Agostini JV. Potential pitfalls of disease-specific guidelines for patients with multiple conditions. N Engl J Med. 2004 Dec 30;351(27):2870-4. doi: 10.1056/NEJMsb042458. No abstract available.

  PMID: 15625341 BACKGROUND

• Vaghela P, Sutin AR. Discrimination and sleep quality among older US adults: the mediating role of psychological distress. Sleep Health. 2016 Jun;2(2):100-108. doi: 10.1016/j.sleh.2016.02.003. Epub 2016 Apr 4.

  PMID: 28923251 BACKGROUND

• Beck AT, Steer RA, Brown GK. Beck Depression Inventory: second edition manual. San Antonio (TX): The Psychological Corporation, 1996.

  BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Fava GA, Guidi J. The pursuit of euthymia. World Psychiatry. 2020 Feb;19(1):40-50. doi: 10.1002/wps.20698.

  PMID: 31922678 BACKGROUND

• Kellner R. A symptom questionnaire. J Clin Psychiatry. 1987 Jul;48(7):268-74.

  PMID: 3597327 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Ryff CD. Happiness is everything or is it? Explorations on the meaning of psychological well-being. Journal of Personality and Social Psychology 57(6):1069-81, 1989.

  BACKGROUND

• Spoormaker VI, Verbeek I, van den Bout J, Klip EC. Initial validation of the SLEEP-50 questionnaire. Behav Sleep Med. 2005;3(4):227-46. doi: 10.1207/s15402010bsm0304_4.

  PMID: 16190812 BACKGROUND

Related Links

• American Academy of Sleep Medicine
• National Sleep Foundation
• National Institute of Health

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being; Sleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior; Health Behavior

Study Officials

• Marie-Pierre St-Onge, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Medicine

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: April 28, 2020
• Primary Completion: January 17, 2021
• Study Completion: April 20, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after the completion of the study.
• Access Criteria: Request data in writing by contacting the PI.

Locations

US (1)