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Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial.

Publication ,  Journal Article
Felder, JN; Epel, ES; Neuhaus, J; Krystal, AD; Prather, AA
Published in: Jama Psychiatry
May 1, 2020

IMPORTANCE: Despite the prevalence and adverse consequences of prenatal insomnia, a paucity of research is available regarding interventions to improve insomnia symptoms during pregnancy. OBJECTIVE: To test the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) compared with standard treatment among pregnant women with insomnia symptoms. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial enrolled pregnant women from November 23, 2016, to May 22, 2018. Of the 2258 women assessed for eligibility using an online self-report questionnaire, 208 were randomized to receive digital CBT-I (n = 105) or standard treatment (n = 103) for insomnia. Participants were pregnant up to 28 weeks' gestation, and they either had elevated insomnia symptom severity or met the criteria for insomnia caseness as determined by self-report questionnaires. Participants completed outcome measures at 10 weeks (postintervention) and 18 weeks (follow-up) after randomization. All study visits were completed remotely, and the intervention was delivered digitally. Data were analyzed between December 12, 2018, and July 2, 2019. INTERVENTIONS: Digital CBT-I consisted of 6 weekly sessions of approximately 20 minutes each. Standard treatment reflected standard care. Women receiving standard treatment had no limits placed on the receipt of nonstudy treatments, including medication and psychotherapy. MAIN OUTCOMES AND MEASURES: All outcomes were assessed remotely using self-report questionnaires administered via online survey. The primary outcome was the change in insomnia symptom severity (measured by the Insomnia Severity Index) from baseline to postintervention. Secondary outcomes were sleep efficiency and nightly sleep duration (defined by sleep diary), global sleep quality (measured by the Pittsburgh Sleep Quality Index), depressive symptom severity (measured by the Edinburgh Postnatal Depression Scale), and anxiety symptom severity (measured by the Generalized Anxiety Disorder Scale-7). For each outcome, we also examined the change from baseline to follow-up. RESULTS: The 208 participants had a mean (SD) age of 33.6 (3.7) years and a mean (SD) gestational age of 17.6 (6.3) weeks at baseline. Most of the participants were white (138 [66.3%]), married or cohabiting (196 [94.2%]), had a college degree (180 [86.5%]), and earned $100 000 or more per year (141 [67.8%]). Women randomized to receive digital CBT-I experienced statistically significantly greater improvements in insomnia symptom severity from baseline to postintervention compared with women randomized to receive standard treatment (time-by-group interaction, difference = -0.36; 95% CI, -0.48 to -0.23; χ2 = 29.8; P < .001; d = -1.03). Improvements from baseline to postintervention for all secondary outcomes, with the exception of sleep duration, were statistically significant. A similar pattern of results was evident for the change from baseline to follow-up. CONCLUSIONS AND RELEVANCE: In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02805998.

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Published In

Jama Psychiatry

DOI

EISSN

2168-6238

Publication Date

May 1, 2020

Volume

77

Issue

5

Start / End Page

484 / 492

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Telemedicine
  • Surveys and Questionnaires
  • Sleep Initiation and Maintenance Disorders
  • Pregnancy Complications
  • Pregnancy
  • Humans
  • Female
  • Cognitive Behavioral Therapy
  • Adult
 

Citation

APA
Chicago
ICMJE
MLA
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Felder, J. N., Epel, E. S., Neuhaus, J., Krystal, A. D., & Prather, A. A. (2020). Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial. Jama Psychiatry, 77(5), 484–492. https://doi.org/10.1001/jamapsychiatry.2019.4491
Felder, Jennifer N., Elissa S. Epel, John Neuhaus, Andrew D. Krystal, and Aric A. Prather. “Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial.Jama Psychiatry 77, no. 5 (May 1, 2020): 484–92. https://doi.org/10.1001/jamapsychiatry.2019.4491.
Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial. Jama Psychiatry. 2020 May 1;77(5):484–92.
Felder, Jennifer N., et al. “Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial.Jama Psychiatry, vol. 77, no. 5, May 2020, pp. 484–92. Pubmed, doi:10.1001/jamapsychiatry.2019.4491.
Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial. Jama Psychiatry. 2020 May 1;77(5):484–492.

Published In

Jama Psychiatry

DOI

EISSN

2168-6238

Publication Date

May 1, 2020

Volume

77

Issue

5

Start / End Page

484 / 492

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Telemedicine
  • Surveys and Questionnaires
  • Sleep Initiation and Maintenance Disorders
  • Pregnancy Complications
  • Pregnancy
  • Humans
  • Female
  • Cognitive Behavioral Therapy
  • Adult