Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcomes? Study protocol for a randomized controlled trial.
Circadian
Memory support
Sleep
Transdiagnostic
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
03 Oct 2024
03 Oct 2024
Historique:
received:
05
07
2024
accepted:
16
09
2024
medline:
4
10
2024
pubmed:
4
10
2024
entrez:
4
10
2024
Statut:
epublish
Résumé
Poor memory for treatment is associated with poorer treatment adherence and poorer patient outcomes. The memory support intervention (MSI) was developed to improve patient memory for treatment with the goal of improving patient outcomes. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether a new, streamlined, and potent version of the MSI improves outcomes for midlife and older adults. This streamlined MSI is comprised of constructive memory supports that will be applied to a broader range of treatment content. The platform for this study is the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). We will focus on midlife and older adults who are low income and experiencing mobility impairments. Participants (N = 178) will be randomly allocated to TranS-C + MSI or TranS-C alone. Both intervention arms include eight 50-min weekly sessions. Assessments will be conducted at pre-treatment, post-treatment, 6-, and 12-month follow-up (6FU and 12FU). Aim 1 will compare the effects of TranS-C + MSI versus TranS-C alone on sleep and circadian functioning, daytime functioning, well-being, and patient memory. Aim 2 will test whether patient memory for treatment mediates the relationship between treatment condition and patient outcomes. Aim 3 will evaluate if previously reported poor treatment response subgroups will moderate the relationship between treatment condition and (a) patient memory for treatment and (b) treatment outcome. Exploratory analyses will compare treatment condition on (a) patient adherence, patient-rated treatment credibility, and patient utilization of treatment contents, and (b) provider-rated acceptability, appropriateness, and feasibility. This study has the potential to provide evidence for (a) the efficacy of a new simplified version of the MSI for maintaining health, well-being, and functioning, (b) the wider application of the MSI for midlife and older adults and to the treatment of sleep and circadian problems, and (c) the efficacy of the MSI for sub-groups who are likely to benefit from the intervention. ClinicalTrials.gov NCT05986604. Registered on 2 August 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Poor memory for treatment is associated with poorer treatment adherence and poorer patient outcomes. The memory support intervention (MSI) was developed to improve patient memory for treatment with the goal of improving patient outcomes. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether a new, streamlined, and potent version of the MSI improves outcomes for midlife and older adults. This streamlined MSI is comprised of constructive memory supports that will be applied to a broader range of treatment content. The platform for this study is the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). We will focus on midlife and older adults who are low income and experiencing mobility impairments.
METHODS
METHODS
Participants (N = 178) will be randomly allocated to TranS-C + MSI or TranS-C alone. Both intervention arms include eight 50-min weekly sessions. Assessments will be conducted at pre-treatment, post-treatment, 6-, and 12-month follow-up (6FU and 12FU). Aim 1 will compare the effects of TranS-C + MSI versus TranS-C alone on sleep and circadian functioning, daytime functioning, well-being, and patient memory. Aim 2 will test whether patient memory for treatment mediates the relationship between treatment condition and patient outcomes. Aim 3 will evaluate if previously reported poor treatment response subgroups will moderate the relationship between treatment condition and (a) patient memory for treatment and (b) treatment outcome. Exploratory analyses will compare treatment condition on (a) patient adherence, patient-rated treatment credibility, and patient utilization of treatment contents, and (b) provider-rated acceptability, appropriateness, and feasibility.
DISCUSSION
CONCLUSIONS
This study has the potential to provide evidence for (a) the efficacy of a new simplified version of the MSI for maintaining health, well-being, and functioning, (b) the wider application of the MSI for midlife and older adults and to the treatment of sleep and circadian problems, and (c) the efficacy of the MSI for sub-groups who are likely to benefit from the intervention.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT05986604. Registered on 2 August 2023.
Identifiants
pubmed: 39363383
doi: 10.1186/s13063-024-08468-0
pii: 10.1186/s13063-024-08468-0
doi:
Banques de données
ClinicalTrials.gov
['NCT05986604']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
650Informations de copyright
© 2024. The Author(s).
Références
Jansen J, Butow PN, van Weert JCM, van Dulmen S, Devine RJ, Heeren TJ, et al. Does age really matter? Recall of information presented to newly referred patients with cancer. J Clin Oncol. 2008;26(33):5450–7.
pubmed: 18936478
doi: 10.1200/JCO.2007.15.2322
Lewkovich GN, Haneline MT. Patient recall of the mechanics of cervical spine manipulation. J Manipulative Physiol Ther. 2005;28(9):708–12.
pubmed: 16326241
doi: 10.1016/j.jmpt.2005.09.014
Lee JY, Harvey AG. Memory for therapy in bipolar disorder and comorbid insomnia. J Consult Clin Psychol. 2015;83(1):92.
pubmed: 25222800
doi: 10.1037/a0037911
Bober SL, Hoke LA, Duda RB, Tung NM. Recommendation recall and satisfaction after attending breast/ovarian cancer risk counseling. J Genet Couns. 2007;16:755–62.
pubmed: 17674165
doi: 10.1007/s10897-007-9109-0
Chambers MJ. Patient recall of recommendations in the behavioural treatment of insomnia. Sleep Research. 1991;20:222.
Linn AJ, van Dijk L, Smit EG, Jansen J, van Weert JCM. May you never forget what is worth remembering: the relation between recall of medical information and medication adherence in patients with inflammatory bowel disease. J Crohns Colitis. 2013;7(11):e543–50.
pubmed: 23660489
doi: 10.1016/j.crohns.2013.04.001
Dong L, Lee JY, Harvey AG. Do improved patient recall and the provision of memory support enhance treatment adherence? J Behav Ther Exp Psychiatry. 2017;54:219–28.
pubmed: 27614662
doi: 10.1016/j.jbtep.2016.08.017
Kravitz RL, Hays RD, Sherbourne CD, DiMatteo MR, Rogers WH, Ordway L, et al. Recall of recommendations and adherence to advice among patients with chronic medical conditions. Arch Intern Med. 1993;153(16):1869–78.
pubmed: 8250648
doi: 10.1001/archinte.1993.00410160029002
Sarfan LD, Zieve G, Gumport NB, Xiong M, Harvey AG. Optimizing outcomes, mechanisms, and recall of Cognitive Therapy for depression: Dose of constructive memory support strategies. Behav Res Ther. 2023;166:104325.
pubmed: 37210887
pmcid: 10513748
doi: 10.1016/j.brat.2023.104325
Schacter DL. The seven sins of memory: How the mind forgets and remembers. Boston: Houghton Mifflin Harcourt; 2002.
Easterbrook JA. The effect of emotion on cue utilization and the organization of behavior. Psychol Rev. 1959;66(3):183.
pubmed: 13658305
doi: 10.1037/h0047707
Ellis HC. The transfer of learning. New York: The Macmillan Company; 1965.
Almkvist O, Fratiglioni L, Agüero-Torres H, Viitanen M, Bäckman L. Cognitive support at episodic encoding and retrieval: Similar patterns of utilization in community-based samples of Alzheimer’s disease and vascular dementia patients. J Clin Exp Neuropsychol. 1999;21(6):816–30.
pubmed: 10649536
doi: 10.1076/jcen.21.6.816.862
Taconnat L, Baudouin A, Fay S, Raz N, Bouazzaoui B, El-Hage W, et al. Episodic memory and organizational strategy in free recall in unipolar depression: The role of cognitive support and executive functions. J Clin Exp Neuropsychol. 2010;32(7):719–27.
pubmed: 20155557
pmcid: 3091267
doi: 10.1080/13803390903512645
Bäckman L, Forsell Y. Episodic memory functioning in a community-based sample of old adults with major depression: utilization of cognitive support. J Abnorm Psychol. 1994;103(2):361.
pubmed: 8040505
doi: 10.1037/0021-843X.103.2.361
Harvey AG, Lee J, Williams J, Hollon SD, Walker MP, Thompson MA, et al. Improving outcome of psychosocial treatments by enhancing memory and learning. Perspect Psychol Sci. 2014;9(2):161–79.
pubmed: 25544856
pmcid: 4276345
doi: 10.1177/1745691614521781
Insel TR. The NIMH experimental medicine initiative. World Psychiatry. 2015;14(2):151.
pubmed: 26043323
pmcid: 4471962
doi: 10.1002/wps.20227
Nielsen L, Riddle M, King JW, Aklin WM, Chen W, Clark D, et al. The NIH Science of Behavior Change Program: Transforming the science through a focus on mechanisms of change. Behav Res Ther. 2018;101:3–11.
pubmed: 29110885
doi: 10.1016/j.brat.2017.07.002
Zieve GG, Dong L, Harvey AG. Patient memory for psychological treatment contents: Assessment, intervention, and future directions for a novel transdiagnostic mechanism of change. Behav Chang. 2019;36(1):1–11.
doi: 10.1017/bec.2019.1
Canning EA, Harackiewicz JM, Priniski SJ, Hecht CA, Tibbetts Y, Hyde JS. Improving performance and retention in introductory biology with a utility-value intervention. J Educ Psychol. 2018;110(6):834.
pubmed: 30294006
doi: 10.1037/edu0000244
Theobald EJ, Hill MJ, Tran E, Agrawal S, Arroyo EN, Behling S, et al. Active learning narrows achievement gaps for underrepresented students in undergraduate science, technology, engineering, and math. Proc Natl Acad Sci. 2020;117(12):6476–83.
pubmed: 32152114
pmcid: 7104254
doi: 10.1073/pnas.1916903117
Harackiewicz JM, Priniski SJ. Improving student outcomes in higher education: The science of targeted intervention. Annu Rev Psychol. 2018;69:409–35.
pubmed: 28934586
doi: 10.1146/annurev-psych-122216-011725
Zieve GG, Dong L, Weaver C, Ong SL, Harvey AG. Patient constructive learning behavior in cognitive therapy: A pathway for improving patient memory for treatment? Behav Res Ther. 2019;116:80–9.
pubmed: 30852323
doi: 10.1016/j.brat.2019.02.006
Harvey AG, Lee J, Smith RL, Gumport NB, Hollon SD, Rabe-Hesketh S, et al. Improving outcome for mental disorders by enhancing memory for treatment. Behav Res Ther. 2016;81:35–46.
pubmed: 27089159
pmcid: 5559714
doi: 10.1016/j.brat.2016.03.007
Dong L, Zieve G, Gumport NB, Armstrong CC, Alvarado-Martinez CG, Martinez A, et al. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? A randomized controlled trial. Behav Res Ther. 2022;157:104167.
pubmed: 35963181
doi: 10.1016/j.brat.2022.104167
Zieve GG, Sarfan LD, Dong L, Tiab SS, Tran M, Harvey AG. Cognitive Therapy-as-Usual versus Cognitive Therapy plus the Memory Support Intervention for adults with depression: 12-month outcomes and opportunities for improved efficacy in a secondary analysis of a randomized controlled trial. Behav Res Ther. 2023;170:104419.
pubmed: 37879246
doi: 10.1016/j.brat.2023.104419
Sarfan LD, Zieve GG, Mujir F, Gumport NB, Xiong M, Harvey AG. Serial mediators of memory support strategies used with Cognitive Therapy for depression: Improving outcomes through patient adherence and treatment skills. Behav Ther. 2023;54(1):141–55.
pubmed: 36608972
doi: 10.1016/j.beth.2022.07.012
Richardson IM, Zieve GG, Harvey AG. Conceptual and procedural treatment contents in CBT for procrastination: Differential client recall and effects of recall on outcome. Atlanta: In Poster presentation at the meeting of the Association for Behavioral and Cognitive Therapies; 2019.
Zieve GG, Armstrong CC, Richardson IM, Garcia SB, Harvey AG. Measuring memory for treatment using patient conceptualizations of clinical vignettes: a pilot psychometric study in the context of cognitive therapy for depression. Cognit Ther Res. 2022;46(4):791–808.
doi: 10.1007/s10608-022-10293-1
Dong L, Lee JY, Harvey AG. Memory support strategies and bundles: A pathway to improving cognitive therapy for depression? J Consult Clin Psychol. 2017;85(3):187.
pubmed: 28221056
pmcid: 5563823
doi: 10.1037/ccp0000167
Dobson KS. A meta-analysis of the efficacy of cognitive therapy for depression. J Consult Clin Psychol. 1989;57(3):414.
pubmed: 2738214
doi: 10.1037/0022-006X.57.3.414
Rowe JW, Fulmer T, Fried L. Preparing for better health and health care for an aging population. JAMA. 2016;316(16):1643–4.
pubmed: 27668895
doi: 10.1001/jama.2016.12335
Administration for Community Living. 2019 Profile of Older Americans. 2020. https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2019ProfileOlderAmericans508.pdf
Li B, Zhu X, Hou J, Wang P, Li J. Combined cognitive training vs. memory strategy training in healthy older adults. Front Psychol. 2016;7:188403.
doi: 10.3389/fpsyg.2016.00834
Salthouse TA. When does age-related cognitive decline begin? Neurobiol Aging. 2009;30(4):507–14.
pubmed: 19231028
pmcid: 2683339
doi: 10.1016/j.neurobiolaging.2008.09.023
Glisky EL. Changes in cognitive function in human aging. In: Riddle D, editor. Brain aging: models, methods, and mechanisms. Boca Raton (FL): CRC Press; 2007. p. 3–20.
Parikh PK, Troyer AK, Maione AM, Murphy KJ. The impact of memory change on daily life in normal aging and mild cognitive impairment. Gerontologist. 2016;56(5):877–85.
pubmed: 26035897
doi: 10.1093/geront/gnv030
Ward EV, Berry CJ, Shanks DR, Moller PL, Czsiser E. Aging predicts decline in explicit and implicit memory: A life-span study. Psychol Sci. 2020;31(9):1071–83.
pubmed: 32735485
doi: 10.1177/0956797620927648
Zayas CE, He Z, Yuan J, Maldonado-Molina M, Hogan W, Modave F, et al. Examining healthcare utilization patterns of elderly and middle-aged adults in the United States. In: The Twenty-Ninth International Flairs Conference. 2016;2016:361-6.
Fok M, Stewart R, Besset A, Ritchie K, Prince M. Incidence and persistence of sleep complaints in a community older population. Int J Geriatr Psychiatry. 2010;25(1):37–45.
pubmed: 19513987
doi: 10.1002/gps.2295
Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995;18(6):425–32.
pubmed: 7481413
doi: 10.1093/sleep/18.6.425
Vitiello MV. Sleep in normal aging. Sleep Med Clin. 2006;1(2):171–6.
doi: 10.1016/j.jsmc.2006.04.007
Ohayon MM, Carskadon MA, Guilleminault C, Vitiello MV. Meta-analysis of quantitative sleep parameters from childhood to old age in healthy individuals: developing normative sleep values across the human lifespan. Sleep. 2004;27(7):1255–73.
pubmed: 15586779
doi: 10.1093/sleep/27.7.1255
Jonasdottir SS, Minor K, Lehmann S. Gender differences in nighttime sleep patterns and variability across the adult lifespan: a global-scale wearables study. Sleep. 2021;44(2):zsaa169.
pubmed: 32886772
doi: 10.1093/sleep/zsaa169
Sarsour K, Morin CM, Foley K, Kalsekar A, Walsh JK. Association of insomnia severity and comorbid medical and psychiatric disorders in a health plan-based sample: insomnia severity and comorbidities. Sleep Med. 2010;11(1):69–74.
pubmed: 19410512
doi: 10.1016/j.sleep.2009.02.008
Chiu HY, Wang MY, Chang CK, Chen CM, Chou KR, Tsai JC, et al. Early morning awakening and nonrestorative sleep are associated with increased minor non-fatal accidents during work and leisure time. Accid Anal Prev. 2014;71:10–4.
pubmed: 24875435
doi: 10.1016/j.aap.2014.05.002
Laugsand LE, Strand LB, Vatten LJ, Janszky I, Bjørngaard JH. Insomnia symptoms and risk for unintentional fatal injuries—the HUNT study. Sleep. 2014;37(11):1777–86.
pubmed: 25364073
pmcid: 4196061
doi: 10.5665/sleep.4170
Chen P, Chiu H, Chiu H. Daytime sleepiness is independently associated with falls in older adults with dementia. Geriatr Gerontol Int. 2016;16(7):850–5.
pubmed: 26245804
doi: 10.1111/ggi.12567
Hill EL, Cumming RG, Lewis R, Carrington S, Le CDG. Sleep disturbances and falls in older people. J Gerontol A Biol Sci Med Sci. 2007;62(1):62
doi: 10.1093/gerona/62.1.62
Stone KL, Blackwell TL, Ancoli-Israel S, Cauley JA, Redline S, Marshall LM, et al. Sleep disturbances and risk of falls in older community-dwelling men: the outcomes of Sleep Disorders in Older Men (MrOS Sleep) Study. J Am Geriatr Soc. 2014;62(2):299–305.
pubmed: 24428306
pmcid: 3945231
doi: 10.1111/jgs.12649
Tang NKY, Wright KJ, Salkovskis PM. Prevalence and correlates of clinical insomnia co-occurring with chronic back pain. J Sleep Res. 2007;16(1):85–95.
pubmed: 17309767
doi: 10.1111/j.1365-2869.2007.00571.x
Endeshaw YW, Yoo W. Association between social and physical activities and insomnia symptoms among community-dwelling older adults. J Aging Health. 2016;28(6):1073–89.
pubmed: 26690253
doi: 10.1177/0898264315618921
Karlin BE, Trockel M, Spira AP, Taylor CB, Manber R. National evaluation of the effectiveness of cognitive behavioral therapy for insomnia among older versus younger veterans. Int J Geriatr Psychiatry. 2015;30(3):308–15.
pubmed: 24890708
doi: 10.1002/gps.4143
Lovato N, Lack L, Kennaway DJ. Comparing and contrasting therapeutic effects of cognitive-behavior therapy for older adults suffering from insomnia with short and long objective sleep duration. Sleep Med. 2016;22:4–12.
pubmed: 27544829
doi: 10.1016/j.sleep.2016.04.001
Sadler P, McLaren S, Klein B, Harvey J, Jenkins M. Cognitive behavior therapy for older adults with insomnia and depression: a randomized controlled trial in community mental health services. Sleep. 2018;41(8):zsy104.
doi: 10.1093/sleep/zsy104
Tanaka M, Kusaga M, Nyamathi AM, Tanaka K. Effects of brief cognitive behavioral therapy for insomnia on improving depression among community-dwelling older adults: A randomized controlled comparative study. Worldviews Evid Based Nurs. 2019;16(1):78–86.
pubmed: 30714310
doi: 10.1111/wvn.12342
Vitiello MV, Rybarczyk B, Von Korff M, Stepanski EJ. Cognitive behavioral therapy for insomnia improves sleep and decreases pain in older adults with co-morbid insomnia and osteoarthritis. J Clin Sleep Med. 2009;5(4):355–62.
pubmed: 19968014
pmcid: 2725255
doi: 10.5664/jcsm.27547
Irwin MR, Carrillo C, Sadeghi N, Bjurstrom MF, Breen EC, Olmstead R. Prevention of incident and recurrent major depression in older adults with insomnia: a randomized clinical trial. JAMA Psychiat. 2022;79(1):33–41.
doi: 10.1001/jamapsychiatry.2021.3422
Harvey AG, Buysse DJ. Treating sleep problems: A transdiagnostic approach. Guilford Publications; 2017.
Armstrong CC, Dong L, Harvey AG. Mediators and moderators of outcome from the Transdiagnostic Sleep and Circadian Intervention for adults with severe mental illness in a community setting. Behav Res Ther. 2022;151:104053.
pubmed: 35152036
doi: 10.1016/j.brat.2022.104053
Sarfan LD, Gasperetti CE, Gumport NB, Harvey AG. Outcomes from the transdiagnostic sleep and circadian intervention (TranS-C) for midlife and older adults with serious mental illness and sleep and circadian dysfunction. Behav Ther. 2022;53(4):585–99.
pubmed: 35697424
pmcid: 10927276
doi: 10.1016/j.beth.2022.02.001
Marquett RM, Thompson LW, Reiser RP, Holland JM, O’Hara RM, Kesler SR, et al. Psychosocial predictors of treatment response to cognitive-behavior therapy for late-life depression: an exploratory study. Aging Ment Health. 2013;17(7):830–8.
pubmed: 23631698
pmcid: 3755101
doi: 10.1080/13607863.2013.791661
Gumport NB, Harvey AG. Memory and learning for sleep and circadian treatment in serious mental illness treated in a community mental health setting. Behav Res Ther. 2022;149:104029.
pubmed: 34995953
doi: 10.1016/j.brat.2021.104029
Caudle DD, Senior AC, Wetherell JL, Rhoades HM, Beck JG, Kunik ME, et al. Cognitive errors, symptom severity, and response to cognitive behavior therapy in older adults with generalized anxiety disorder. Am J Geriatr Psychiatry. 2007;15(8):680–9.
pubmed: 17670997
doi: 10.1097/JGP.0b013e31803c550d
Mohlman J, Gorman JM. The role of executive functioning in CBT: a pilot study with anxious older adults. Behav Res Ther. 2005;43(4):447–65.
pubmed: 15701356
doi: 10.1016/j.brat.2004.03.007
Wetherell JL, Thorp SR, Patterson TL, Golshan S, Jeste DV, Gatz M. Quality of life in geriatric generalized anxiety disorder: a preliminary investigation. J Psychiatr Res. 2004;38(3):305–12.
pubmed: 15003436
doi: 10.1016/j.jpsychires.2003.09.003
Foley DJ, Monjan A, Simonsick EM, Wallace RB, Blazer DG. Incidence and remission of insomnia among elderly adults: an epidemiologic study of 6,800 persons over three years. Sleep. 1999;22:S366–72.
pubmed: 10394609
Marti CN, Kunik ME, Choi NG. The reciprocal relationship between depression and disability in low-income homebound older adults following tele-depression treatment. Int J Geriatr Psychiatry. 2021;36(6):802–10.
pubmed: 33275787
doi: 10.1002/gps.5480
Choi NG, Marti CN, Wilson NL, Chen GJ, Sirrianni L, Hegel MT, et al. Effect of telehealth treatment by lay counselors vs by clinicians on depressive symptoms among older adults who are homebound: A randomized clinical trial. JAMA Netw Open. 2020;3(8):e2015648–e2015648.
pubmed: 32865577
pmcid: 7489833
doi: 10.1001/jamanetworkopen.2020.15648
Choi NG, Pepin R, Marti CN, Stevens CJ, Bruce ML. Improving social connectedness for homebound older adults: randomized controlled trial of tele-delivered behavioral activation versus tele-delivered friendly visits. Am J Geriatr Psychiatry. 2020;28(7):698–708.
pubmed: 32238297
pmcid: 8767809
doi: 10.1016/j.jagp.2020.02.008
Havercamp SM, Scott HM. National health surveillance of adults with disabilities, adults with intellectual and developmental disabilities, and adults with no disabilities. Disabil Health J. 2015;8(2):165–72.
pubmed: 25595297
doi: 10.1016/j.dhjo.2014.11.002
Reichard A, Stransky M, Phillips K, McClain M, Drum C. Prevalence and reasons for delaying and foregoing necessary care by the presence and type of disability among working-age adults. Disabil Health J. 2017;10(1):39–47.
pubmed: 27771217
doi: 10.1016/j.dhjo.2016.08.001
Iezzoni LI, McCarthy EP, Davis RB, Siebens H. Mobility impairments and use of screening and preventive services. Am J Public Health. 2000;90(6):955.
pubmed: 10846515
pmcid: 1446260
doi: 10.2105/AJPH.90.6.955
Granberg RE, Heyer A, Gehrman PR, Gunter PW, Hoff NA, Guth A, et al. Patient and provider experiences with CBT-I administered in-person or via telemedicine: a randomized non-inferiority trial. Cogent Psychol. 2022;9(1):2038936.
doi: 10.1080/23311908.2022.2038936
Gehrman P, Gunter P, Findley J, Frasso R, Weljie AM, Kuna ST, et al. Randomized noninferiority trial of telehealth delivery of cognitive behavioral treatment of insomnia compared to in-person care. J Clin Psychiatry. 2021;82(5):36315.
doi: 10.4088/JCP.20m13723
Holmqvist M, Vincent N, Walsh K. Web-vs telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014;15(2):187–95.
pubmed: 24461370
doi: 10.1016/j.sleep.2013.10.013
Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning clinical science: unifying the discipline to improve the public health. Clinical psychological science. 2014;2(1):22–34.
pubmed: 25821658
pmcid: 4374633
doi: 10.1177/2167702613497932
Sundararaman R. US mental health delivery system infrastructure: A primer. Washington, DC: Congressional Research Service; 2009.
Sorensen JL, Rawson RA, Guydish JE, Zweben JE. Drug abuse treatment through collaboration: Practice and research partnerships that work. Washington DC: American Psychological Association; 2003.
Kravitz HM, Ganz PA, Bromberger J, Powell LH, Sutton-Tyrrell K, Meyer PM. Sleep difficulty in women at midlife: a community survey of sleep and the menopausal transition. Menopause. 2003;10(1):19–28.
pubmed: 12544673
Zhang B, Wing YK. Sex differences in insomnia: a meta-analysis. Sleep. 2006;29(1):85–93.
pubmed: 16453985
doi: 10.1093/sleep/29.1.85
Zarulli V, Barthold Jones JA, Oksuzyan A, Lindahl-Jacobsen R, Christensen K, Vaupel JW. Women live longer than men even during severe famines and epidemics. Proc Natl Acad Sci. 2018;115(4):E832–40.
pubmed: 29311321
pmcid: 5789901
doi: 10.1073/pnas.1701535115
Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0. World Health Organization. 2010.
Von Korff M, Ustun TB, Ormel J, Kaplan I, Simon GE. Self-report disability in an international primary care study of psychological illness. J Clin Epidemiol. 1996;49(3):297–303.
doi: 10.1016/0895-4356(95)00512-9
Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, et al. Development of short forms from the PROMIS™ sleep disturbance and sleep-related impairment item banks. Behav Sleep Med. 2012;10(1):6–24.
doi: 10.1080/15402002.2012.636266
Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–9.
pubmed: 15817019
doi: 10.1111/j.1532-5415.2005.53221.x
Epstein LJ, Kristo D, Strollo PJ Jr, FN, Malhotra A, Patil SP, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263–76.
pubmed: 19960649
doi: 10.5664/jcsm.27497
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540–5.
pubmed: 1798888
doi: 10.1093/sleep/14.6.540
Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, et al. Reliability of the structured clinical interview for DSM-5 sleep disorders module. J Clin Sleep Med. 2018;14(3):459–64.
pubmed: 29458705
pmcid: 5837848
doi: 10.5664/jcsm.7000
Amorim P. Mini International Neuropsychiatric Interview (MINI): validação de entrevista breve para diagnóstico de transtornos mentais. Brazilian Journal of Psychiatry. 2000;22:106–15.
doi: 10.1590/S1516-44462000000300003
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–77.
pubmed: 22193671
pmcid: 3893686
doi: 10.1176/appi.ajp.2011.10111704
Bootzin RR. Stimulus control treatment for insomnia. Proceedings of the American Psychological Association. 1972;7:395–6.
Spielman AJ, Saskin P, Thorpy MJ. Treatment of chronic insomnia by restriction of time in bed. Sleep. 1987;10(1):45–56.
pubmed: 3563247
Riedel BW, Lichstein KL, Dwyer WO. Sleep compression and sleep education for older insomniacs: self-help versus therapist guidance. Psychol Aging. 1995;10(1):54.
pubmed: 7779317
doi: 10.1037/0882-7974.10.1.54
Lichstein KL, Riedel BW, Wilson NM, Lester KW, Aguillard RN. Relaxation and sleep compression for late-life insomnia: a placebo-controlled trial. J Consult Clin Psychol. 2001;69(2):227.
pubmed: 11393600
doi: 10.1037/0022-006X.69.2.227
Harvey AG. A cognitive model of insomnia. Behav Res Ther. 2002;40(8):869–93.
pubmed: 12186352
doi: 10.1016/S0005-7967(01)00061-4
Morin CM, Stone J, Trinkle D, Mercer J, Remsberg S. Dysfunctional beliefs and attitudes about sleep among older adults with and without insomnia complaints. Psychol Aging. 1993;8(3):463.
pubmed: 8216967
doi: 10.1037/0882-7974.8.3.463
Aloia MS, Di Dio L, Ilniczky N, Perlis ML, Greenblatt DW, Giles DE. Improving compliance with nasal CPAP and vigilance in older adults with OSAHS. Sleep and Breathing. 2001;5(01):13–22.
pubmed: 11868136
doi: 10.1055/s-2001-12789
Krakow B, Zadra A. Imagery rehearsal therapy: principles and practice. Sleep Med Clin. 2010;5(2):289–98.
doi: 10.1016/j.jsmc.2010.01.004
Morin CM, Bastien C, Guay B, Radouco-Thomas M, Leblanc J, Vallières A. Randomized clinical trial of supervised tapering and cognitive behavior therapy to facilitate benzodiazepine discontinuation in older adults with chronic insomnia. Am J Psychiatry. 2004;161(2):332–42.
pubmed: 14754783
doi: 10.1176/appi.ajp.161.2.332
Tighe CA, Phares A, Weiner DK, Beehler GP, VanSwearingen J, Harvey AG, et al. Adaptation and Preliminary Test of a Behavioral Intervention to Promote Sleep Health in Cardiac Rehabilitation. Behavioral Sleep Medicine. 2024:1-6.
Craik FIM, Lockhart RS. Levels of processing: A framework for memory research. J Verbal Learning Verbal Behav. 1972;11(6):671–84.
doi: 10.1016/S0022-5371(72)80001-X
Murphy GL, Medin DL. The role of theories in conceptual coherence. Psychol Rev. 1985;92(3):289.
pubmed: 4023146
doi: 10.1037/0033-295X.92.3.289
Ley P, Bradshaw PW, Eaves D, Walker CM. A method for increasing patients’ recall of information presented by doctors1. Psychol Med. 1973;3(2):217–20.
pubmed: 4715854
doi: 10.1017/S0033291700048558
Hunt RR, McDaniel MA. The enigma of organization and distinctiveness. J Mem Lang. 1993;32(4):421–45.
doi: 10.1006/jmla.1993.1023
Baddeley A. Working memory: Theories, models, and controversies. Annu Rev Psychol. 2012;63:1–29.
pubmed: 21961947
doi: 10.1146/annurev-psych-120710-100422
Baddeley AD, Hitch G. Working Memory. In: Bower GH, editor. Psychology of Learning and Motivation. Academic Press; 1974. p. 47–89. Available from: https://www.sciencedirect.com/science/article/pii/S0079742108604521
Rogers T, Milkman KL. Reminders through association. Psychol Sci. 2016;27(7):973–86.
pubmed: 27207873
pmcid: 5510470
doi: 10.1177/0956797616643071
Gick ML, Holyoak KJ. Schema induction and analogical transfer. Cogn Psychol. 1983;15(1):1–38.
doi: 10.1016/0010-0285(83)90002-6
Lockhart RS, Lamon M, Gick ML. Conceptual transfer insimple insight problems. Mem Cognit. 1988;16:36–44.
pubmed: 28255827
doi: 10.3758/BF03197743
Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, et al. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010;33(6):781–92.
pubmed: 20550019
pmcid: 2880437
doi: 10.1093/sleep/33.6.781
Dong L, Martinez AJ, Buysse DJ, Harvey AG. A composite measure of sleep health predicts concurrent mental and physical health outcomes in adolescents prone to eveningness. Sleep Health. 2019;5(2):166–74.
pubmed: 30928117
pmcid: 6452900
doi: 10.1016/j.sleh.2018.11.009
Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, et al. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012;35(2):287–302.
pubmed: 22294820
pmcid: 3250369
doi: 10.5665/sleep.1642
Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006;29(9):1155–73.
pubmed: 17040003
doi: 10.1093/sleep/29.9.1155
Coates TJ, Killen JD, George J, Marchini E, Silverman S, Thoresen C. Estimating sleep parameters: a multitrait-multimethod analysis. J Consult Clin Psychol. 1982;50(3):345.
pubmed: 7096737
doi: 10.1037/0022-006X.50.3.345
Sheehan DV, Harnett-Sheehan K, Raj B. The measurement of disability. Int Clin Psychopharmacol. 1996;11:89–95.
pubmed: 8923116
doi: 10.1097/00004850-199606003-00015
Leon AC, Olfson M, Portera L, Farber L, Sheehan DV. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. The international journal of psychiatry in medicine. 1997;27(2):93–105.
pubmed: 9565717
doi: 10.2190/T8EM-C8YH-373N-1UWD
Konecky B, Meyer EC, Marx BP, Kimbrel NA, Morissette SB. Using the WHODAS 2.0 to assess functional disability associated with DSM-5 mental disorders. Am J Psych. 2014;171(8):818–20.
doi: 10.1176/appi.ajp.2014.14050587
Diener ED, Emmons RA, Larsen RJ, Griffin S. The satisfaction with life scale. J Pers Assess. 1985;49(1):71–5.
pubmed: 16367493
doi: 10.1207/s15327752jpa4901_13
Watson D, Clark LA, Carey G. Positive and negative affectivity and their relation to anxiety and depressive disorders. J Abnorm Psychol. 1988;97(3):346.
pubmed: 3192830
doi: 10.1037/0021-843X.97.3.346
Lee JY, Worrell FC, Harvey AG. The development and validation of the Memory Support Rating Scale. Psychol Assess. 2016;28(6):715.
pubmed: 26389597
doi: 10.1037/pas0000219
Gumport NB, Williams JJ, Harvey AG. Learning cognitive behavior therapy. J Behav Ther Exp Psychiatry. 2015;48:164–9.
pubmed: 25898288
pmcid: 4426215
doi: 10.1016/j.jbtep.2015.03.015
Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The cognitive failures questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982;21(1):1–16.
pubmed: 7126941
doi: 10.1111/j.2044-8260.1982.tb01421.x
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.
pubmed: 11132119
doi: 10.1016/S0005-7916(00)00012-4
Gumport NB, Dolsen EA, Harvey AG. Usefulness and utilization of treatment elements from the Transdiagnostic Sleep and Circadian Intervention for adolescents with an evening circadian preference. Behav Res Ther. 2019;123: 103504.
pubmed: 31678861
pmcid: 6864305
doi: 10.1016/j.brat.2019.103504
Condon HE, Maurer LF, Kyle SD. Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Sleep Med Rev. 2021;56: 101412.
pubmed: 33422935
doi: 10.1016/j.smrv.2020.101412
Espie CA, Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, et al. Effect of digital cognitive behavioral therapy for insomnia on health, psychological well-being, and sleep-related quality of life: a randomized clinical trial. JAMA Psychiat. 2019;76(1):21–30.
doi: 10.1001/jamapsychiatry.2018.2745
Milani SA, Marsiske M, Striley CW. Discriminative ability of Montreal Cognitive Assessment subtests and items in racial and ethnic minority groups. Alzheimer Dis Assoc Disord. 2019;33(3):226–32.
pubmed: 31058685
pmcid: 6710139
doi: 10.1097/WAD.0000000000000310
Dautzenberg G, Lijmer J, Beekman A. Clinical value of the Montreal Cognitive Assessment (MoCA) in patients suspected of cognitive impairment in old age psychiatry. Using the MoCA for triaging to a memory clinic. Cogn Neuropsychiatry. 2021;26(1):1–17.
pubmed: 33272076
doi: 10.1080/13546805.2020.1850434
Pendlebury ST, Welch SJV, Cuthbertson FC, Mariz J, Mehta Z, Rothwell PM. Telephone assessment of cognition after transient ischemic attack and stroke: modified telephone interview of cognitive status and telephone Montreal Cognitive Assessment versus face-to-face Montreal Cognitive Assessment and neuropsychological battery. Stroke. 2013;44(1):227–9.
pubmed: 23138443
doi: 10.1161/STROKEAHA.112.673384
Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, et al. Prevalence of obstructive sleep apnea in the general population: a systematic review. Sleep Med Rev. 2017;34:70–81.
pubmed: 27568340
doi: 10.1016/j.smrv.2016.07.002
Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, et al. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015;3(4):310–8.
pubmed: 25682233
pmcid: 4404207
doi: 10.1016/S2213-2600(15)00043-0
Johns MW. Sensitivity and specificity of the multiple sleep latency test (MSLT), the maintenance of wakefulness test and the Epworth sleepiness scale: failure of the MSLT as a gold standard. J Sleep Res. 2000;9(1):5–11.
pubmed: 10733683
doi: 10.1046/j.1365-2869.2000.00177.x
Gumport NB, Dong L, Lee JY, Zhao X, Harvey AG. Development and preliminary validation of the treatment adherence rating scale. J Behav Ther Exp Psychiatry. 2023;79: 101832.
pubmed: 36584414
doi: 10.1016/j.jbtep.2022.101832
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12:1–12.
doi: 10.1186/s13012-017-0635-3
Gumport NB, Stephanie HY, Mullin AC, Mirzadegan IA, Harvey AG. The validation of a provider-reported fidelity measure for the transdiagnostic sleep and circadian intervention in a community mental health setting. Behav Ther. 2020;51(5):800–13.
pubmed: 32800307
doi: 10.1016/j.beth.2019.11.006
Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001;285(14):1856–64.
pubmed: 11308399
doi: 10.1001/jama.285.14.1856
Gumport NB, Zieve GG, Dong L, Harvey AG. The Development and Validation of the Memory Support Treatment Provider Checklist. Behav Ther. 2021;52(4):932–44.
pubmed: 34134832
doi: 10.1016/j.beth.2020.11.005
Spybrook J, Raudenbush SW, Liu X feng, Congdon R, Martínez A. Optimal design for longitudinal and multilevel research: Documentation for the “Optimal Design” software. New York: William T. Grant Foundation; 2006.
Raudenbush SW, Spybrook J, Congdon R, Liu X, Martinez A, Bloom H, et al. Optimal design software for multi-level and longitudinal research (Version 3.01)[Software]. 2011.
Fritz MS, MacKinnon DP. Required sample size to detect the mediated effect. Psychol Sci. 2007;18(3):233–9.
pubmed: 17444920
doi: 10.1111/j.1467-9280.2007.01882.x
Qiu W, Qiu MW. Package ‘powerMediation.’ R Foundation for Statistical Computing. 2018;
Dong N, Maynard R. PowerUp! : A Tool for Calculating Minimum Detectable Effect Sizes and Minimum Required Sample Sizes for Experimental and Quasi-Experimental Design Studies. J Res Educ Eff. 2013Jan;1(6):24–67.
Fischer D, Lombardi DA, Marucci-Wellman H, Roenneberg T. Chronotypes in the US–influence of age and sex. PLoS ONE. 2017;12(6): e0178782.
pubmed: 28636610
pmcid: 5479630
doi: 10.1371/journal.pone.0178782
Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J Roy Stat Soc: Ser B (Methodol). 1995;57(1):289–300.
doi: 10.1111/j.2517-6161.1995.tb02031.x
Raudenbush SW, Bryk AS. Hierarchical linear models: Applications and data analysis methods. Vol. 1. sage; 2002.
Hox J, Moerbeek M, Van de Schoot R. Multilevel analysis: Techniques and applications. Routledge; 2017.
Goldstein H. Multilevel statistical models. John Wiley & Sons; 2011.
Little RJA, Rubin DB. Statistical analysis with missing data. Vol. 793. John Wiley & Sons; 2019.
Black AC, Harel O, Betsy MD. Missing data techniques for multilevel data: Implications of model misspecification. J Appl Stat. 2011;38(9):1845–65.
doi: 10.1080/02664763.2010.529882
Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. Bmj. 2012;345:e5840.
Kim S, Kim Y, Lim SS, Ryoo JH, Yoon JH. Long commute time and sleep problems with gender difference in work–life balance: a cross-sectional study of more than 25,000 workers. Saf Health Work. 2019;10(4):470–5.
pubmed: 31890330
pmcid: 6933265
doi: 10.1016/j.shaw.2019.08.001
Zhang B, Wing YK. Sex differences in insomnia: a meta-analysis. Sleep. 2006;29(1):85–93.
pubmed: 16453985
doi: 10.1093/sleep/29.1.85
Beck F, Léger D, Fressard L, Peretti-Watel P, Verger P, Group C. Covid-19 health crisis and lockdown associated with high level of sleep complaints and hypnotic uptake at the population level. J Sleep Res. 2021;30(1): e13119.
doi: 10.1111/jsr.13119
Kyle SD, Miller CB, Rogers Z, Siriwardena AN, MacMahon KM, Espie CA. Sleep restriction therapy for insomnia is associated with reduced objective total sleep time, increased daytime somnolence, and objectively impaired vigilance: implications for the clinical management of insomnia disorder. Sleep. 2014;37(2):229–37.
pubmed: 24497651
pmcid: 3900612
doi: 10.5665/sleep.3386
Vincent N, Lewycky S, Finnegan H. Barriers to engagement in sleep restriction and stimulus control in chronic insomnia. J Consult Clin Psychol. 2008;76(5):820.
pubmed: 18837599
doi: 10.1037/0022-006X.76.5.820
American Psychological Association. Ethical Principles of Psychologists and Code of Conduct. Washington, DC: American Psychological Association; 2017. Available from: http://www.apa.org/ethics/code/index.aspx .
Walker ER, Cummings JR, Hockenberry JM, Druss BG. Insurance status, use of mental health services, and unmet need for mental health care in the United States. Psychiatr Serv. 2015;66(6):578–84.
pubmed: 25726980
pmcid: 4461054
doi: 10.1176/appi.ps.201400248
Mander BA, Winer JR, Walker MP. Sleep and human aging. Neuron. 2017;94(1):19–36.
pubmed: 28384471
pmcid: 5810920
doi: 10.1016/j.neuron.2017.02.004
Gumport NB, Harvey AG. Memory and learning for sleep and circadian treatment in serious mental illness treated in a community mental health setting. Behav Res Ther. 2022;149:104029.
pubmed: 34995953
doi: 10.1016/j.brat.2021.104029