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Randomized Controlled Trial
. 2022 Mar-Apr;20(2):143-163.
doi: 10.1080/15402002.2021.1895793. Epub 2021 Mar 15.

Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy

David A Kalmbach  1 , Philip Cheng  1 , Thomas Roth  1 , Leslie M Swanson  2 , Andrea Cuamatzi-Castelan  1 , Andrea Roth  3 , Christopher L Drake  1
Affiliations
Randomized Controlled Trial

Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy

David A Kalmbach et al. Behav Sleep Med. 2022 Mar-Apr.

Abstract

Objective: Insomnia affects over half of pregnant and postpartum women. Early evidence indicates that cognitive-behavioral therapy for insomnia (CBTI) improves maternal sleep and mood. However, standard CBTI may be less efficacious in perinatal women than the broader insomnia population. This study sought to identify patient characteristics in a perinatal sample associated with poor response to CBTI, and characterize patient feedback to identify areas of insomnia therapy to tailor for the perinatal experience.

Participants: Secondary analysis of 46 pregnant women with insomnia symptoms who were treated with digital CBTI in a randomized controlled trial.

Methods: We assessed insomnia, cognitive arousal, and depression before and after prenatal treatment, then 6 weeks postpartum. Patients provided feedback on digital CBTI.

Results: Residual cognitive arousal after treatment was the most robust factor associated with treatment non-response. Critically, CBTI responders and non-responders differed on no other sociodemographic or pretreatment metrics. After childbirth, short sleep (<6 hrs/night) was associated with maternal reports of poor infant sleep quality. Patient feedback indicated that most patients preferred online treatment to in-person treatment. Although women described digital CBTI as convenient and helpful, many patients indicated that insomnia therapy would be improved if it addressed sleep challenges unique to pregnancy and postpartum. Patients requested education on maternal and infant sleep, flexibility in behavioral sleep strategies, and guidance to manage infant sleep.

Conclusions: Modifying insomnia therapy to better alleviate refractory cognitive arousal and address the changing needs of women as they progress through pregnancy and early parenting may increase efficacy for perinatal insomnia.Name: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum DepressionURL: clinicaltrials.govRegistration: NCT03596879.

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Conflict of interest statement

Declaration of Interest Statement

Dr. Kalmbach reports receiving nonfinancial support from Big Health Inc (provision of Sleepio for use in this clinical trial). Dr. Cheng has received research support from Harmony Biosciences. Dr. Thomas Roth has received research support from Aventis, Cephalon, Glaxo Smith Kline, Neurocrine, Pfizer, Sanofi, Schering-Plough, Sepracor, Somaxon, Syrex, Takeda, TransOral, Wyeth and Xenoport and has acted as a consultant for Abbott, Acadia, Acoglix, Actelion, Alchemers, Alza, Ancil, Arena, Astra Zeneca, Aventis, AVER, BMS, BTG, Cephalon, Cypress, Dove, Elan, Eli Lilly, Evotec, Forest, Glaxo Smith Kline, Hypnion, Impax, Intec, Intra-Cellular, Jazz, Johnson & Johnson, King, Lundbeck, McNeil, Medici Nova, Merck & Co., Neurim, Neurocrine, Neurogen, Novartis, Orexo, Organon, Prestwick, Procter-Gamble, Pfizer, Purdue, Resteva, Roche, Sanofi, Schering-Plough, Sepracor, Servier, Shire, Somaxon, Syrex, Takeda, TransOral, Vanda, Vivometrics, Wyeth, Yamanuchi, and Xenoport. Dr. Drake has received financial research support from Eisai Co., Procter & Gamble, Jazz, Suven; and has served on speakers bureau for Harmony Biosciences. No other financial or non-financial interests exist.

Figures

Figure 1.
Figure 1.
Flowchart of study enrollment and participation.
See this image and copyright information in PMC

References

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