Dataset Information

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

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.

SUBMITTER: Kalmbach DA

PROVIDER: S-EPMC8440671 | biostudies-literature | 2022 Mar-Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Kalmbach David A DA Cheng Philip P Roth Thomas T Swanson Leslie M LM Cuamatzi-Castelan Andrea A Roth Andrea A Drake Christopher L CL

Behavioral sleep medicine 20210315 2

<h4>Objective</h4>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 ...[more]

PMID: 33719795

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Project description:ImportanceAlthough digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many randomized clinical trials and is recommended as a first-line treatment option, few studies have systematically examined its effectiveness, engagement, durability, and adaptability in clinical settings.ObjectiveTo evaluate the clinical effectiveness, engagement, durability, and adaptability of dCBT-I.Design, setting, and participantsThis retrospective cohort study was conducted using longitudinal data collected via a mobile app named Good Sleep 365 between November 14, 2018, and February 28, 2022. Three therapeutic modes (ie, dCBT-I, medication, and their combination) were compared at month 1, month 3, and month 6 (primary). Inverse probability of treatment weighting (IPTW) using propensity scores was applied to enable homogeneous comparisons between the 3 groups.ExposuresTreatment with dCBT-I, medication therapy, or combination therapy according to prescriptions.Main outcomes and measuresThe Pittsburgh Sleep Quality Index (PSQI) score and its essential subitems were used as the primary outcomes. Effectiveness on comorbid somnolence, anxiety, depression, and somatic symptoms were used as secondary outcomes. Cohen d effect size, P value, and standardized mean difference (SMD) were used to measure differences in treatment outcomes. Changes in outcomes and response rates (≥3 points change in PSQI score) were also reported.ResultsA total of 4052 patients (mean [SD] age, 44.29 [12.01] years; 3028 [74.7%] female participants) were selected for dCBT-I (n = 418), medication (n = 862), and their combination (n = 2772). Compared with the change in PSQI score at 6 months for participants receiving medication alone (from a mean [SD] of 12.85 [3.49] to 8.92 [4.03]), both dCBT-I (from a mean [SD] of 13.51 [3.03] to 7.15 [3.25]; Cohen d, -0.50; 95% CI, -0.62 to -0.38; P < .001; SMD = 0.484) and combination therapy (from a mean [SD] of 12.92 [3.49] to 6.98 [3.43]; Cohen d, 0.50; 95% CI, 0.42 to 0.58; P < .001; SMD = 0.518) were associated with significant reductions; dCBT-I had a comparable effect as combination therapy (Cohen d, 0.05; 95% CI, -0.05 to 0.15; P = .66; SMD = 0.05), but showed unstable durability. Outcomes of dCBT-I improved steadily and rapidly during the first 3 months, and then fluctuated. The response rates with dCBT-I and combination therapy were higher than with medication. Changes in secondary outcomes indicated statistically significant benefits from dCBT-I and combination therapy. The results of subgroup analysis were consistent with the main findings, demonstrating the superiority of dCBT-I vs medication therapy in various subpopulations.Conclusions and relevanceIn this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits for insomnia. Future studies are needed to analyze its clinical effectiveness and reliability in distinct subpopulations.

Project description:BACKGROUND:Insomnia in adolescents is common, persistent, and associated with poor mental health including anxiety and depression. Insomnia in adolescents attending child mental health services is seldom directly treated, and the effects of digital cognitive behavioral therapy (CBT) for insomnia (CBTi) on the mental health of adolescents with significant mental health problems are unknown. OBJECTIVE:This open study aimed to assess the feasibility of adding supported Web-based CBT for insomnia to the usual care of young people aged 14 to 17 years attending specialist child and adolescent mental health services (CAMHS). METHODS:A total of 39 adolescents with insomnia aged 14 to 17 years attending specialist CAMHS were assessed and offered digital CBTi. The digital intervention was Sleepio, an evidence-based, self-directed, fully automated CBTi that has proven effective in multiple randomized controlled trials with adults. Self-report assessments of sleep (Sleep Condition Indicator [SCI], Insomnia Severity Scale, and Web- or app-based sleep diaries), anxiety (Revised Child Anxiety and Depression Scale [RCADS]), and depression (Mood and Feelings Questionnaire [MFQ]) were completed at baseline and post intervention. Postuse interviews assessed satisfaction with digital CBTi. RESULTS:Average baseline sleep efficiency was very poor (53%), with participants spending an average of 9.6 hours in bed but only 5.1 hours asleep. All participants scored less than 17 on the SCI, with 92% (36/39) participants scoring 15 or greater on the Insomnia Severity Scale, suggesting clinical insomnia. Of the 39 participants, 36 (92%) scored 27 or greater on the MFQ for major depression and 20 (51%) had clinically elevated symptoms of anxiety. The majority of participants (38/49, 78%) were not having any treatment for their insomnia, with the remaining 25% (12/49) receiving medication. Sleepio was acceptable, with 77% (30/39) of the participants activating their account and 54% (21/39) completing the program. Satisfaction was high, with 84% (16/19) of the participants finding Sleepio helpful, 95% (18/19) indicating that they would recommend it to a friend, and 37% (7/19) expressing a definite preference for a digital intervention. Statistically significant pre-post improvements were found in weekly diaries of sleep efficiency (P=.005) and sleep quality (P=.001) and on measures of sleep (SCI: P=.001 and Insomnia Severity Index: P=.001), low mood (MFQ: P=.03), and anxiety (RCADS: P=.005). CONCLUSIONS:Our study has a number of methodological limitations, particularly the small sample size, absence of a comparison group and no follow-up assessment. Nonetheless, our findings are encouraging and suggest that digital CBTi for young people with mental health problems might offer an acceptable and an effective way to improve both sleep and mental health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/11324.

Dataset Information

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

Objective

Participants

Methods

Results

Conclusions

Publications

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

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