Clinical trial NCT04986007 - References

Suicidal Ideation — Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults

Citation(s)

•   Bastien CH, Vallieres A, Morin CM
  Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
•   Bernert RA, Kim JS, Iwata NG, Perlis ML
  Sleep disturbances as an evidence-based suicide risk factor. Curr Psychiatry Rep. 2015 Mar;17(3):554. doi: 10.1007/s11920-015-0554-4.
•   Birchler-Pedross A, Frey S, Chellappa SL, Gotz T, Brunner P, Knoblauch V, Wirz-Justice A, Cajochen C
  Higher frontal EEG synchronization in young women with major depression: a marker for increased homeostatic sleep pressure? Sleep. 2011 Dec 1;34(12):1699-706. doi: 10.5665/sleep.1440.
•   Boivin DB, Czeisler CA, Dijk DJ, Duffy JF, Folkard S, Minors DS, Totterdell P, Waterhouse JM
  Complex interaction of the sleep-wake cycle and circadian phase modulates mood in healthy subjects. Arch Gen Psychiatry. 1997 Feb;54(2):145-52. doi: 10.1001/archpsyc.1997.01830140055010.
•   Brewster GS, Riegel B, Gehrman PR
  Insomnia in the Older Adult. Sleep Med Clin. 2018 Mar;13(1):13-19. doi: 10.1016/j.jsmc.2017.09.002. Epub 2017 Nov 22.
•   Cajochen C, Brunner DP, Krauchi K, Graw P, Wirz-Justice A
  Power density in theta/alpha frequencies of the waking EEG progressively increases during sustained wakefulness. Sleep. 1995 Dec;18(10):890-4. doi: 10.1093/sleep/18.10.890.
•   Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM
  The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
•   Cheng P, Luik AI, Fellman-Couture C, Peterson E, Joseph CLM, Tallent G, Tran KM, Ahmedani BK, Roehrs T, Roth T, Drake CL
  Efficacy of digital CBT for insomnia to reduce depression across demographic groups: a randomized trial. Psychol Med. 2019 Feb;49(3):491-500. doi: 10.1017/S0033291718001113. Epub 2018 May 24.
•   Christensen H, Batterham PJ, Gosling JA, Ritterband LM, Griffiths KM, Thorndike FP, Glozier N, O'Dea B, Hickie IB, Mackinnon AJ
  Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016 Apr;3(4):333-41. doi: 10.1016/S2215-0366(15)00536-2. Epub 2016 Jan 28. Erratum In: Lancet Psychiatry. 2016 Apr;3(4):320.
•   Clark L, Dombrovski AY, Siegle GJ, Butters MA, Shollenberger CL, Sahakian BJ, Szanto K
  Impairment in risk-sensitive decision-making in older suicide attempters with depression. Psychol Aging. 2011 Jun;26(2):321-330. doi: 10.1037/a0021646.
•   Dawson DA, Grant BF, Stinson FS
  The AUDIT-C: screening for alcohol use disorders and risk drinking in the presence of other psychiatric disorders. Compr Psychiatry. 2005 Nov-Dec;46(6):405-16. doi: 10.1016/j.comppsych.2005.01.006.
•   Dombrovski AY, Butters MA, Reynolds CF 3rd, Houck PR, Clark L, Mazumdar S, Szanto K
  Cognitive performance in suicidal depressed elderly: preliminary report. Am J Geriatr Psychiatry. 2008 Feb;16(2):109-15. doi: 10.1097/JGP.0b013e3180f6338d.
•   Dombrovski AY, Clark L, Siegle GJ, Butters MA, Ichikawa N, Sahakian BJ, Szanto K
  Reward/Punishment reversal learning in older suicide attempters. Am J Psychiatry. 2010 Jun;167(6):699-707. doi: 10.1176/appi.ajp.2009.09030407. Epub 2010 Mar 15.
•   Drummond SP, Paulus MP, Tapert SF
  Effects of two nights sleep deprivation and two nights recovery sleep on response inhibition. J Sleep Res. 2006 Sep;15(3):261-5. doi: 10.1111/j.1365-2869.2006.00535.x.
•   Ferentinos P, Porichi E, Christodoulou C, Dikeos D, Papageorgiou C, Douzenis A
  Sleep disturbance as a proximal predictor of suicidal intent in recently hospitalized attempters. Sleep Med. 2016 Mar;19:1-7. doi: 10.1016/j.sleep.2015.10.021. Epub 2015 Nov 24.
•   Frey S, Birchler-Pedross A, Hofstetter M, Brunner P, Gotz T, Munch M, Blatter K, Knoblauch V, Wirz-Justice A, Cajochen C
  Young women with major depression live on higher homeostatic sleep pressure than healthy controls. Chronobiol Int. 2012 Apr;29(3):278-94. doi: 10.3109/07420528.2012.656163.
•   Fujino Y, Mizoue T, Tokui N, Yoshimura T
  Prospective cohort study of stress, life satisfaction, self-rated health, insomnia, and suicide death in Japan. Suicide Life Threat Behav. 2005 Apr;35(2):227-37. doi: 10.1521/suli.35.2.227.62876.
•   Gibbs LM, Dombrovski AY, Morse J, Siegle GJ, Houck PR, Szanto K
  When the solution is part of the problem: problem solving in elderly suicide attempters. Int J Geriatr Psychiatry. 2009 Dec;24(12):1396-404. doi: 10.1002/gps.2276.
•   Grandner MA, Olivier K, Gallagher R, Hale L, Barrett M, Branas C, Killgore WDS, Parthasarathy S, Gehrels JA, Alfonso-Miller P
  Quantifying impact of real-world barriers to sleep: The Brief Index of Sleep Control (BRISC). Sleep Health. 2020 Oct;6(5):587-593. doi: 10.1016/j.sleh.2020.01.013. Epub 2020 May 29.
•   Harris LM, Huang X, Linthicum KP, Bryen CP, Ribeiro JD
  Sleep disturbances as risk factors for suicidal thoughts and behaviours: a meta-analysis of longitudinal studies. Sci Rep. 2020 Aug 17;10(1):13888. doi: 10.1038/s41598-020-70866-6.
•   Hedegaard H, Curtin SC, Warner M
  Suicide Mortality in the United States, 1999-2017. NCHS Data Brief. 2018 Nov;(330):1-8.
•   Hedstrom AK, Hossjer O, Bellocco R, Ye W, Trolle LY, Akerstedt T
  Insomnia in the context of short sleep increases suicide risk. Sleep. 2021 Apr 9;44(4):zsaa245. doi: 10.1093/sleep/zsaa245.
•   Kay DB, Dombrovski AY, Buysse DJ, Reynolds CF, Begley A, Szanto K
  Insomnia is associated with suicide attempt in middle-aged and older adults with depression. Int Psychogeriatr. 2016 Apr;28(4):613-9. doi: 10.1017/S104161021500174X. Epub 2015 Nov 10.
•   Kleiman EM, Turner BJ, Fedor S, Beale EE, Huffman JC, Nock MK
  Examination of real-time fluctuations in suicidal ideation and its risk factors: Results from two ecological momentary assessment studies. J Abnorm Psychol. 2017 Aug;126(6):726-738. doi: 10.1037/abn0000273. Epub 2017 May 8.
•   Klingman KJ, Jungquist CR, Perlis ML
  Questionnaires that screen for multiple sleep disorders. Sleep Med Rev. 2017 Apr;32:37-44. doi: 10.1016/j.smrv.2016.02.004. Epub 2016 Feb 27.
•   Lewinsohn PM, Seeley JR, Roberts RE, Allen NB
  Center for Epidemiologic Studies Depression Scale (CES-D) as a screening instrument for depression among community-residing older adults. Psychol Aging. 1997 Jun;12(2):277-87. doi: 10.1037//0882-7974.12.2.277.
•   Li SX, Lam SP, Yu MW, Zhang J, Wing YK
  Nocturnal sleep disturbances as a predictor of suicide attempts among psychiatric outpatients: a clinical, epidemiologic, prospective study. J Clin Psychiatry. 2010 Nov;71(11):1440-6. doi: 10.4088/JCP.09m05661gry.
•   Lin HT, Lai CH, Perng HJ, Chung CH, Wang CC, Chen WL, Chien WC
  Insomnia as an independent predictor of suicide attempts: a nationwide population-based retrospective cohort study. BMC Psychiatry. 2018 May 2;18(1):117. doi: 10.1186/s12888-018-1702-2.
•   Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N
  Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8.
•   Manber R, Simpson NS, Bootzin RR
  A step towards stepped care: delivery of CBT-I with reduced clinician time. Sleep Med Rev. 2015 Feb;19:3-5. doi: 10.1016/j.smrv.2014.09.003. Epub 2014 Oct 8. No abstract available.
•   Margolis SA, Kelly DA, Daiello LA, Davis J, Tremont G, Pillemer S, Denby C, Ott BR
  Anticholinergic/Sedative Drug Burden and Subjective Cognitive Decline in Older Adults at Risk of Alzheimer's Disease. J Gerontol A Biol Sci Med Sci. 2021 May 22;76(6):1037-1043. doi: 10.1093/gerona/glaa222.
•   May CP, Hasher L
  Synchrony effects in inhibitory control over thought and action. J Exp Psychol Hum Percept Perform. 1998 Apr;24(2):363-79. doi: 10.1037//0096-1523.24.2.363.
•   May CP
  Synchrony effects in cognition: the costs and a benefit. Psychon Bull Rev. 1999 Mar;6(1):142-7. doi: 10.3758/bf03210822.
•   McCall WV, Benca RM, Rosenquist PB, Youssef NA, McCloud L, Newman JC, Case D, Rumble ME, Szabo ST, Phillips M, Krystal AD
  Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT): A Randomized Clinical Trial. Am J Psychiatry. 2019 Nov 1;176(11):957-965. doi: 10.1176/appi.ajp.2019.19030267. Epub 2019 Sep 20.
•   McGirr A, Dombrovski AY, Butters MA, Clark L, Szanto K
  Deterministic learning and attempted suicide among older depressed individuals: cognitive assessment using the Wisconsin Card Sorting Task. J Psychiatr Res. 2012 Feb;46(2):226-32. doi: 10.1016/j.jpsychires.2011.10.001. Epub 2011 Oct 22.
•   Monk TH, Buysse DJ, Reynolds CF 3rd, Berga SL, Jarrett DB, Begley AE, Kupfer DJ
  Circadian rhythms in human performance and mood under constant conditions. J Sleep Res. 1997 Mar;6(1):9-18. doi: 10.1046/j.1365-2869.1997.00023.x.
•   Monk TH, Buysse DJ, Reynolds CF 3rd, Jarrett DB, Kupfer DJ
  Rhythmic vs homeostatic influences on mood, activation, and performance in young and old men. J Gerontol. 1992 Jul;47(4):P221-7. doi: 10.1093/geronj/47.4.p221.
•   Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T; American Academy of Sleep Medicine
  Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep. 2006 Nov;29(11):1415-9.
•   Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C
  The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
•   Morrison GE, Simone CM, Ng NF, Hardy JL
  Reliability and validity of the NeuroCognitive Performance Test, a web-based neuropsychological assessment. Front Psychol. 2015 Nov 3;6:1652. doi: 10.3389/fpsyg.2015.01652. eCollection 2015.
•   Munch M, Knoblauch V, Blatter K, Wirz-Justice A, Cajochen C
  Is homeostatic sleep regulation under low sleep pressure modified by age? Sleep. 2007 Jun;30(6):781-92. doi: 10.1093/sleep/30.6.781.
•   Murray G, Allen NB, Trinder J
  Mood and the circadian system: investigation of a circadian component in positive affect. Chronobiol Int. 2002 Nov;19(6):1151-69. doi: 10.1081/cbi-120015956.
•   Niggemyer KA, Begley A, Monk T, Buysse DJ
  Circadian and homeostatic modulation of sleep in older adults during a 90-minute day study. Sleep. 2004 Dec 15;27(8):1535-41. doi: 10.1093/sleep/27.8.1535.
•   Patel D, Steinberg J, Patel P
  Insomnia in the Elderly: A Review. J Clin Sleep Med. 2018 Jun 15;14(6):1017-1024. doi: 10.5664/jcsm.7172.
•   Perlis ML, Grandner MA, Brown GK, Basner M, Chakravorty S, Morales KH, Gehrman PR, Chaudhary NS, Thase ME, Dinges DF
  Nocturnal Wakefulness as a Previously Unrecognized Risk Factor for Suicide. J Clin Psychiatry. 2016 Jun;77(6):e726-33. doi: 10.4088/JCP.15m10131.
•   Perlis ML, Grandner MA, Chakravorty S, Bernert RA, Brown GK, Thase ME
  Suicide and sleep: Is it a bad thing to be awake when reason sleeps? Sleep Med Rev. 2016 Oct;29:101-7. doi: 10.1016/j.smrv.2015.10.003. Epub 2015 Oct 19.
•   Pigeon WR, Funderburk JS, Cross W, Bishop TM, Crean HF
  Brief CBT for insomnia delivered in primary care to patients endorsing suicidal ideation: a proof-of-concept randomized clinical trial. Transl Behav Med. 2019 Nov 25;9(6):1169-1177. doi: 10.1093/tbm/ibz108.
•   Pigeon WR, Pinquart M, Conner K
  Meta-analysis of sleep disturbance and suicidal thoughts and behaviors. J Clin Psychiatry. 2012 Sep;73(9):e1160-7. doi: 10.4088/JCP.11r07586.
•   Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ
  The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
•   Puustinen J, Lahteenmaki R, Polo-Kantola P, Salo P, Vahlberg T, Lyles A, Neuvonen PJ, Partinen M, Raiha I, Kivela SL
  Effect of withdrawal from long-term use of temazepam, zopiclone or zolpidem as hypnotic agents on cognition in older adults. Eur J Clin Pharmacol. 2014 Mar;70(3):319-29. doi: 10.1007/s00228-013-1613-6. Epub 2013 Dec 12.
•   Radloff LS
  The use of the Center for Epidemiologic Studies Depression Scale in adolescents and young adults. J Youth Adolesc. 1991 Apr;20(2):149-66. doi: 10.1007/BF01537606.
•   Richard-Devantoy S, Szanto K, Butters MA, Kalkus J, Dombrovski AY
  Cognitive inhibition in older high-lethality suicide attempters. Int J Geriatr Psychiatry. 2015 Mar;30(3):274-83. doi: 10.1002/gps.4138. Epub 2014 May 12.
•   Rossler W, Angst J, Ajdacic-Gross V, Haker H, Berrouiguet S, Ujeyl M, Glozier N, Hengartner MP
  Sleep Disturbances and Suicidality-A Longitudinal Analysis From a Representative Community Study Over 30 Years. Front Psychiatry. 2018 Jul 16;9:320. doi: 10.3389/fpsyt.2018.00320. eCollection 2018.
•   Schmidt C, Collette F, Cajochen C, Peigneux P
  A time to think: circadian rhythms in human cognition. Cogn Neuropsychol. 2007 Oct;24(7):755-89. doi: 10.1080/02643290701754158.
•   Spitzer RL, Kroenke K, Williams JB, Lowe B
  A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
•   Trockel M, Karlin BE, Taylor CB, Brown GK, Manber R
  Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. Sleep. 2015 Feb 1;38(2):259-65. doi: 10.5665/sleep.4410.
•   Tubbs AS, Fernandez FX, Perlis ML, Hale L, Branas CC, Barrett M, Chakravorty S, Khader W, Grandner MA
  Suicidal ideation is associated with nighttime wakefulness in a community sample. Sleep. 2021 Jan 21;44(1):zsaa128. doi: 10.1093/sleep/zsaa128.
•   Tubbs AS, Harrison-Monroe P, Fernandez FX, Perlis ML, Grandner MA
  When reason sleeps: attempted suicide during the circadian night. J Clin Sleep Med. 2020 Oct 15;16(10):1809-1810. doi: 10.5664/jcsm.8662.
•   Tubbs AS, Perlis ML, Basner M, Chakravorty S, Khader W, Fernandez F, Grandner MA
  Relationship of Nocturnal Wakefulness to Suicide Risk Across Months and Methods of Suicide. J Clin Psychiatry. 2020 Feb 25;81(2):19m12964. doi: 10.4088/JCP.19m12964.
•   Valdez P, Ramirez C, Garcia A, Talamantes J, Cortez J
  Circadian and homeostatic variation in sustained attention. Chronobiol Int. 2010 Jan;27(2):393-416. doi: 10.3109/07420521003765861.
•   Verweij IM, Romeijn N, Smit DJ, Piantoni G, Van Someren EJ, van der Werf YD
  Sleep deprivation leads to a loss of functional connectivity in frontal brain regions. BMC Neurosci. 2014 Jul 19;15:88. doi: 10.1186/1471-2202-15-88.
•   Wang HE, Campbell-Sills L, Kessler RC, Sun X, Heeringa SG, Nock MK, Ursano RJ, Jain S, Stein MB
  Pre-deployment insomnia is associated with post-deployment post-traumatic stress disorder and suicidal ideation in US Army soldiers. Sleep. 2019 Feb 1;42(2):zsy229. doi: 10.1093/sleep/zsy229.
•   WHO ASSIST Working Group
  The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
•   Wright KP, Lowry CA, Lebourgeois MK
  Circadian and wakefulness-sleep modulation of cognition in humans. Front Mol Neurosci. 2012 Apr 18;5:50. doi: 10.3389/fnmol.2012.00050. eCollection 2012.
•   Wyatt JK, Ritz-De Cecco A, Czeisler CA, Dijk DJ
  Circadian temperature and melatonin rhythms, sleep, and neurobehavioral function in humans living on a 20-h day. Am J Physiol. 1999 Oct;277(4 Pt 2):R1152-63. doi: 10.1152/ajpregu.1999.277.4.r1152.
•   Zachariae R, Lyby MS, Ritterband LM, O'Toole MS
  Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
•   Zuromski KL, Cero I, Witte TK
  Insomnia symptoms drive changes in suicide ideation: A latent difference score model of community adults over a brief interval. J Abnorm Psychol. 2017 Aug;126(6):739-749. doi: 10.1037/abn0000282. Epub 2017 May 29.

Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults (ANSWERS-OA): A Pilot, Open-Label, Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia

Details for clinical trial NCT04986007