Clinical trial NCT04316663: Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality
Official title: Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality in a Non-clinical Population of Distressed Adults Reporting Poor Sleep: A Pilot Parallel-arm, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Quality Sleep
Keywords: Sleep Quality
Psychological Distress
Psychological Well-Being
Well-Being Therapy
Sleep Hygiene
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Psychological distress is often associated with poor sleep quality. The role of psychological well-being has often been neglected and most interventions for sleep improvement have focused primarily on sleep disorders. This approach is limited to those individuals who have specific conditions and little resources have been directed to the promotion of sleep quality in the general population.

This study will be a pilot parallel-arm, randomized controlled trial to assess the baseline associations between psychological well-being and different measures of sleep outcomes, determine the effect of elements of a psychological well-being promoting intervention on sleep quality, and examine effect size estimates of key sleep-related outcomes (duration, efficiency, quality) to provide essential data to inform a main efficacy trial.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Heavy caffeine users (\> 400 mg a day, corresponding to about 4 or 5 cups of coffee)

Primary outcomes:
measure: Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to immediate post-intervention
measure: Change in insomnia severity: Insomnia Severity Index (ISI)
timeFrame: Baseline to immediate post-intervention
measure: Changes in total sleep time
timeFrame: Baseline to immediate post-intervention
measure: Changes in sleep onset latency
timeFrame: Baseline to immediate post-intervention
measure: Changes in wake after sleep onset
timeFrame: Baseline to immediate post-intervention
Secondary outcomes:
measure: Change in psychological distress
timeFrame: Baseline to immediate post-intervention
measure: Change in psychological well-being
timeFrame: Baseline to immediate post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Marie-Pierre St-Onge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Benasi G, Guidi J, Rafanelli C, Fava GA. New applications of Well-Being Therapy. Rivista Sperimentale di Freniatria, 1:87-106, 2019
citation: Buysse DJ. Sleep health: can we define it? Does it matter? Sleep. 2014 Jan 1;37(1):9-17. doi: 10.5665/sleep.3298.
citation: 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.
citation: 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.
citation: Fava GA, Sonino N. Psychosomatic assessment. Psychother Psychosom. 2009;78(6):333-41. doi: 10.1159/000235736. Epub 2009 Aug 27.
citation: Fava GA. Well-Being Therapy treatment manual and clinical applications. Basel: Karger, 2016.
citation: 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.
citation: 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.
citation: 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.
citation: Jahoda M. Current concepts of positive mental health. New York, NY, US: Basic Books, 1958.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Rafanelli C, Park SK, Ruini C, Ottolini F, Cazzaro M, Fava GA. Rating wellbeing and distress. Stress & Health 16(1): 55-61, 2000.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Beck AT, Steer RA, Brown GK. Beck Depression Inventory: second edition manual. San Antonio (TX): The Psychological Corporation, 1996.
citation: 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.
citation: Fava GA, Guidi J. The pursuit of euthymia. World Psychiatry. 2020 Feb;19(1):40-50. doi: 10.1002/wps.20698.
citation: Kellner R. A symptom questionnaire. J Clin Psychiatry. 1987 Jul;48(7):268-74.
citation: 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.
citation: 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.
citation: 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.