Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy.

Abstract

Objectives.

Cognitive-behavioral therapy is effective for prenatal insomnia, but unresolved cognitive arousal limits patient outcomes. Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep strategies) on insomnia, depression, and cognitive arousal.

Methods.

A single-arm trial of 12 pregnant women with DSM-5 insomnia disorder (n=5/12 with comorbid depression) who received six sessions of PUMAS delivered individually via telemedicine. Pretreatment and posttreatment outcomes included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale’s cognitive factor (PSASC; nocturnal cognitive arousal), perinatal-focused rumination (appended to PSASC), and Glasgow sleep effort scale.

Results.

Eleven of 12 patients completed all sessions. Intent-to-treat analyses revealed a 10.83-point reduction in ISI (Cohen’s dz=3.05), resulting in 83.3% insomnia remission. PUMAS produced large reductions in EPDS (Cohen’s dz=2.76 in depressed group), resulting in all five baseline depressed patients remitting from depression. PUMAS produced large reductions in nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort (all Cohen’s dzs>2.00). Patients were highly satisfied with PUMAS and identified the telemedicine format and meditation app as positive features of its delivery. Patients rated sleep restriction and guided meditations as the most helpful treatment components.

Conclusion.

Prenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings support the concept and feasibility of PUMAS for pregnant women with insomnia who present with or without comorbid depression.

ClinicalTrials.gov ID: NCT04443959

INTRODUCTION

Many women experience insomnia during pregnancy with approximately half of women reporting clinically significant insomnia symptoms^1-5 and ~20% meeting diagnostic criteria for DSM-5 insomnia disorder.^6,7 Prevalence of insomnia symptoms increases across gestation with frequency rates highest in the third trimester.^1,5 Although insomnia has been historically dismissed as a normative feature of pregnancy,⁸ recent research highlights the serious consequences of untreated insomnia in pregnancy, including increased risk for preterm birth,⁹ infant APGAR scores < 7,¹⁰ infant NICU admissions,¹⁰ infant respiratory distress syndrome,¹⁰ gestational hypertension,¹¹ maternal depression,^3,12-14 and maternal suicidal ideation.^15,16 Indeed, maternal depression is among the most prevalent comorbidities with 20-50% of pregnant women with insomnia having co-occurring depression.^12,16,17 Given the high prevalence and harmful effects of untreated prenatal insomnia, an emerging literature has begun to evaluate the benefits of insomnia therapy during pregnancy.

In 2017, Tomfohr-Madsen et al. conducted a single-arm proof-of-concept trial testing the preliminary efficacy of cognitive-behavioral therapy for insomnia (CBTI) in 13 pregnant women with insomnia.¹⁸ CBTI is the gold standard treatment for insomnia in the general population,¹⁹ but had not yet been evaluated for prenatal insomnia. Results from the single-arm trial showed that women who participated in five weekly CBTI group sessions reported significant reductions in insomnia symptoms, depression, and fatigue,¹⁸ thereby supporting the concept of treating prenatal insomnia with CBTI.

In 2019, Manber and colleagues conducted a rigorous randomized controlled trial (RCT) confirming the efficacy of CBTI in pregnancy as delivered by a therapist in an individual format.²⁰ Not only did CBTI reduce insomnia during pregnancy, but CBTI also alleviated comorbid depression symptoms. These antidepressant effects are critical given the high rate of depression comorbidity,^12,16,17 and these results supported the role of insomnia therapeutics in managing perinatal depression. In a large RCT, CBTI benefits were extended to pregnant women with subclinical insomnia symptoms,²¹ indicating that pregnant women with even mild sleep disruptions benefit from intervention. To increase access to insomnia therapy, two additional RCTs supported the efficacy of CBTI as delivered via an automated digital program.^22,23 Importantly, findings consistently show that clinician-led and digital CBTI during pregnancy produce durable benefits for sleep and depression symptoms into postpartum.^21,23,24

However, findings from RCTs also reveal suboptimal clinical response to CBTI for a subgroup of patients with unresolved cognitive arousal symptoms.^25,26 Cognitive arousal—operationalized here as a transdiagnostic phenomenon involving heightened cognitive activity, often in the form of perseverative thinking (e.g., worry, rumination)—is a central feature of insomnia.^27,28 Pregnant women report high levels of cognitive arousal,²⁹ particularly at night,¹⁶ which fuels insomnia,¹² depression,^12,30,31 and thoughts of self-harm and suicide.¹⁵ Unsurprisingly, pregnant women with DSM-5 insomnia disorder report especially high levels of cognitive arousal at night.⁷

Reducing cognitive arousal may be a key treatment mechanism in insomnia therapy to alleviate insomnia and depression.^12,25 Unfortunately, CBTI yields inconsistent and modest effects on cognitive arousal.^23,26,32,33 Even so, when a significant—even if small—effect of CBTI on cognitive arousal is observed, reduced cognitive arousal facilitates therapy effects on insomnia and depression.³² On the other hand, because CBTI produces minimal effects on cognitive arousal symptoms, under-engagement of cognitive arousal symptoms may limit the benefits of standard CBTI during pregnancy for both sleep and non-sleep outcomes.^12,25,26 Thus, insomnia therapy approaches aimed at directly targeting cognitive arousal symptoms have been proposed to enhance treatment outcomes for pregnant women with insomnia and even comorbid depression.^25,26,34

A metacognitive model of insomnia proposed that mindfulness-based interventions (MBIs) directly reduce cognitive arousal.²⁸ As a result, mindfulness-based therapy for insomnia (MBTI) was created by placing behavioral sleep strategies within a MBI framework.^35,36 Clinical trial data show that MBTI produces large reductions in cognitive arousal in the non-perinatal insomnia patient population.^35,37 Moreover, MBTI is superior to non-sleep-focused MBIs at alleviating insomnia symptoms over the long-term.³⁸ These data suggest that combining behavioral sleep strategies with mindfulness components benefits both insomnia and cognitive arousal symptoms.

To date, no clinical trials evaluating a therapeutic approach that combines mindfulness with behavioral sleep strategies (e.g., MBTI) to address perinatal insomnia have been published. Even so, it is notable that everyday mindfulness levels are inversely associated with insomnia, depression, and cognitive arousal during pregnancy, ³⁹ and that mindfulness training protects against the harmful effects of poor sleep on stress during pregnancy.⁴⁰ Importantly, MBIs effectively reduce perseverative thinking and depression during pregnancy with high patient engagement and satisfaction.^41-44 MBIs may be well-received for improving prenatal sleep as evidenced by focus group data from pregnant women with insomnia revealing strong interest in mindfulness programs to improve sleep and alleviate perseverative thinking (e.g., perinatal-focused worry).⁴⁵

Owing to the potential benefits of treating prenatal insomnia with mindfulness and behavioral sleep strategies, we developed Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). Influenced by MBTI,³⁶ PUMAS places behavioral sleep strategies within a MBI framework with all components tailored to pregnancy (see Methods: Study intervention section). The present study was a single-arm proof-of-concept clinical trial testing the acute effects of PUMAS on insomnia, depression, cognitive arousal, and sleep effort in pregnant women with insomnia.

In accordance with clinic operations and patient expectations since the COVID-19 pandemic began, PUMAS was delivered via telemedicine video with a therapist. We examined treatment effects on patient-reported symptoms from pretreatment to posttreatment. We hypothesized that PUMAS patients would report significant reductions in insomnia symptoms, depressive symptoms, nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort. To evaluate the feasibility and potential for patient-uptake, we assessed treatment engagement, treatment satisfaction, patient feedback on treatment components, and patient self-efficacy after completing the PUMAS program.

METHODS

Ethical consideration

Ethical approval was obtained from the Institutional Review Board of Henry Ford Health. Informed written consent was obtained from patients before participation. All patients were informed of the voluntary nature of the study and assured of anonymity, confidentiality, and the right to withdraw at any time.

Study setting, eligibility criteria, and participants

This study was conducted at Henry Ford Health, a large health system in Metro Detroit, Michigan, USA. We emailed an advertisement for an insomnia treatment study to 1,666 pregnant women in our system. 114 women requested a call from our team to learn about the study. Of these 114 women, we discussed study details over the phone with 44 women. At this step, we excluded 16 patients with the most common reason being a lack of iOS device. In the present study, patients were required to access guided meditations via the PUMAS app, which was developed for iOS, thus access to an iOS device was inclusionary (Table 1 for eligibility criteria). Regarding eligibility, gestational age of ≤ 28 weeks at screening was an inclusion criterion, which was selected to allow for adequate opportunity to complete the six-week program before delivery. As insomnia prevalence increases as pregnancy progresses,¹ recruiting patients as late as gestational week 28 (i.e., women entering the 3^rd trimester) allowed us to treat those in most need of prenatal insomnia care. See Figure 1 for CONSORT flow diagram.

Table 1.

Study eligibility criteria for treatment enrollment.

Inclusion	Exclusion
(1) Singleton pregnancy, gestational week 14-31. (2) Access to iPhone or iPad to access PUMAS app.1 (3) Insomnia Severity Index (ISI) score ≥ 11. (4) Ensure adequate sleep opportunity.2 (5) Age ≥ 18, English-speaking. (6) Reliable internet access for telemedicine treatment	(1) High risk pregnancy (age >40y, pre-eclampsia, BMI ≥40, any condition deemed serious risk to mother or fetus; hypertension and diabetes allowed). (2) Active suicidal intent (ideation allowed). (3) Night or rotating shift work. (4) Health condition unsafe for SRT (bipolar, epilepsy, etc.). (5) Patient-reported untreated sleep disorder diagnosis.

Note:

¹Guided meditations were available to patients for home practice via the PUMAS app, which served as a repository for meditation recordings. The app was developed for iOS, thus access to an iPhone or iPad was an inclusion criterion.

²Determined via clinical interview for DSM-5 insomnia disorder, criterion E.

Figure 1.

Study enrollment flowchart.

After learning details, 28 women consented to the study and completed an online survey for eligibility screening and baseline assessment. Of these 28 screeners, 14 women met eligibility criteria (Figure 1 for CONSORT flow diagram and exclusionary data). The most common reason for exclusion was subclinical insomnia symptoms (n=5), children disrupting maternal sleep at least once per week (n=4), and BMI ≥ 40 (n=4; predicts high-risk pregnancy and triggers a referral for a maternal-fetal medicine [MFM] ultrasound in our obstetrics clinics).

After baseline screening, participants were asked to participate in a clinical interview to assess for DSM-5 insomnia disorder. Insomnia diagnosis was largely for descriptive purposes rather than eligibility purposes (i.e., patients did not need to meet criteria for inclusion), except patients were required to report sleep difficulty despite adequate opportunity for sleep (Criterion E) for inclusion (Table 1). At this step, two additional participants were excluded from the study for not participating in the clinical interview, resulting in a total of 12 women enrolled into PUMAS treatment.

Procedures and study outcomes assessment schedule.

See Figure 1 for CONSORT flow diagram. Baseline screening surveys served as pretreatment values for study outcomes, sociodemographics, and other health information. Patients who met preliminary eligibility on the baseline surveys underwent a telemedicine clinical interview to assess diagnostic criteria for DSM-5 insomnia disorder. Within a week from the clinical interview, patients began PUMAS treatment, which included six weekly sessions described below. Posttreatment surveys were administered a week after the final PUMAS session.

Study intervention

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

was delivered via six weekly 60-minute telemedicine (i.e., video) individual sessions. PUMAS was developed by Kalmbach, Ong, Cheng, and Drake of the study team. Influenced by Ong’s mindfulness-based therapy for insomnia (MBTI),^36-38 PUMAS places behavioral sleep strategies within a MBI framework. PUMAS includes efficacious elements of CBTI and MBIs while tailoring sleep and mindfulness strategies to pregnancy. Each PUMAS session includes a mindfulness theme and behavioral sleep strategies (see Table 2 for a brief synopsis of each session). After each session, patients implement behavioral sleep strategies and practice mindfulness exercises at home. PUMAS was designed to be delivered by specialists (psychologists) and non-specialists (e.g., nurses) with foundational training in mindfulness-based intervention and behavioral sleep medicine. In the present study, PUMAS was manualized for study therapists and delivered by two clinical psychologists and a registered nurse. Specifically, each session was a 1:1 format (psychologist or nurse meeting with one patient). Study therapists were clinically supervised by Dr. Kalmbach, the developer of PUMAS.

Table 2.

Brief synopsis of each PUMAS session.

S1: Mindfulness intro & sleep hygiene. Sleep changes in pregnancy, introduction to mindfulness, mindful eating exercise, applying mindfulness principles to sleep (beginner’s mind, non-striving, patience, etc.), review sleep hygiene and create wind-down routine, end with sitting with breath meditation and establishing daily practice.	S4: Mind-body & awareness of unpleasantness. Yoga for mind-body connection. Review meditation practice and pleasant events. Adjust sleep schedule. Introduce mindful awareness of unpleasant events. Body scan for pain. Continue daytime and nighttime meditations, complete unpleasant events diary at home.
S2: Step out of autopilot & SRT. Streams & Clouds thought metaphor, review mindfulness practice and sleep diary, 3-P model of perinatal insomnia emphasizing time awake in bed and cognitive arousal. Modified sleep restriction. Mountain meditation, encourage patient to maintain daily meditation practice.	S5: Acceptance & letting go. Reflect on changes in acceptance & letting go. ‘It is what it is’ meditation. Review meditation practice, adjust sleep schedule. Review unpleasant events. Explore acceptance and letting go of unpleasant experiences. Continue day and night meditations and pleasant/unpleasant diaries.
S3: Compassion, nocturnal cognitive arousal, awareness of pleasantness, & stimulus control. Loving-kindness mediation, review mindfulness practice, adjust sleep schedule, modified stimulus control, mindful awareness of pleasant events, maintain daytime meditations, introduce nighttime meditations.	S6: Gratitude & relapse prevention. Connecting with baby meditation, review meditation practice, adjust sleep schedule, reflect on progress. Create action plan for insomnia (how to identify early signs, how to respond to insomnia). Review infant sleep education, which is provided to patient. End with gratitude meditation.

PUMAS Components.

Honoring pregnancy.

PUMAS includes education on normal vs abnormal perinatal sleep changes and the 3-P model for perinatal insomnia.⁸ All behavioral sleep strategies and mindfulness exercises were adapted for pregnancy.

Behavioral sleep strategies

include implementing a 30-minute wind-down period before bedtime (Session 1), sleep restriction therapy (SRT; Session 2), and stimulus control (Session 3). In a previous RCT examining digital CBTI in prenatal insomnia, SRT and stimulus control were rated favorably,²⁶ but were modified per patient feedback requesting less rigidity and more opportunity for sleep. Modification #1: Traditionally, SRT restricts patient time-in-bed to match sleep duration to minimize nighttime wakefulness. Manber modified SRT for pregnancy by restricting time-in-bed to be 30 minutes longer than the patient’s sleep duration,²⁰ which aligns with the presentation of SRT within MBTI.³⁶ We adopted this SRT modification and set a limit of never restricting time in bed < 6 hrs. Modification #2: Stimulus control involves getting out of bed during prolonged wakefulness at night, then returning to bed when sleepy. This strategy was modified such that, during episodes of prolonged wakefulness in the night, patients could choose to either meditate in bed to uncover sleepiness (the modification) or get out of bed and then return when sleepy (traditional method).

Mindfulness components

help pregnant women alleviate sleep effort and cognitive arousal by slowing wandering minds. MBIs have been successfully adapted to honor the perinatal period in the treatment of stress, depression, and anxiety.^43,44,46-52 In PUMAS, mindfulness exercises include mindful activities (e.g., mindfully bonding with fetus), applying mindful awareness to pleasant and unpleasant experiences, and practicing guided meditations in session and at home (3-5 recordings provided each session). Guided meditations were tailored to pregnancy (e.g., Mountain Meditation includes baby as vital to the mountain base) and are designed to foster maternal-fetal attachment (e.g., expressing compassion, love, and kindness to baby in Loving-Kindness). In each session, clinicians guided patients through one or two meditations, which was followed by a period of discussion to process the meditation experience. For at-home practice, patients listened to guided meditations on the PUMAS app, which served as a repository for all recorded meditations assigned in the program. Within the app, assigned meditations are listed under each session. Notably, 3-5 meditations were associated with each session. At the end of each session, patients were asked to practice with each new meditation at least once before the next session and were also encouraged to listen to previous weeks’ meditations as well. At the end of sessions 1 and 2, patients were asked to meditate at least once per day (not in bed at night). After session 3 until the end of the program, patients were asked to meditate at least twice per day; once in the day and then again in bed at night.

Blinding

Participants were not blind to their intervention but were blind to study hypotheses.

Measures

All study outcomes were assessed via online surveys hosted by Qualtrics. Primary study outcomes included insomnia (Insomnia Severity Index),⁵³ depression (Edinburgh Postnatal Depression Scale),⁵⁴ nocturnal cognitive arousal (Pre-Sleep Arousal Scale’s Cognitive factor),⁵⁵ nocturnal perinatal-focused rumination,¹⁶ and sleep effort (Glasgow sleep effort scale),⁵⁶ which are described below. These measures were assessed at baseline/pretreatment and posttreatment.

Sociodemographic information and history of insomnia treatment

were assessed during baseline screening. Patients reported age, race, annual household income, pregnancy-related health information, and current medications.

Treatment engagement

was assessed via session attendance with six sessions being the maximum number of sessions.

Treatment adherence

regarding at-home mindfulness exercises was assessed at posttreatment via patient reports of days per week they meditated at home during treatment and minutes per day they meditated during treatment.

DSM-5 insomnia disorder⁵⁷

was assessed via a clinical interview by a trained research assistant under the supervision of Dr. Kalmbach. Insomnia disorder was assessed for two purposes: (1) to ensure sleep difficulties occur despite adequate sleep opportunity and (2) for descriptive purposes. Prior research shows that prenatal insomnia—whether meeting diagnostic criteria or not—warrants treatment,^6,7 thus an insomnia diagnosis was not required for inclusion.

DSM-5 insomnia disorder requires sleep disturbance ≥ 3 nights/week that results in daytime impairment and lasts for at least three months for diagnosis. However, as we are interested in insomnia cases that onset prior to and during pregnancy, we described patients who met diagnostic criteria including the 3-month duration as well as those who met diagnostic criteria but with a duration of 1-2 months, the latter is less likely to miss insomnia cases that develop gestationally. Notably, the DSM-5 describes insomnia cases meeting all criteria but lasting 1-2 months as ‘episodic’ and should be coded as an ‘other specified insomnia disorder.’ Patients who endorsed sleep disturbance and daytime impairment criteria and reported a duration of 1 month or longer, despite adequate opportunity for sleep, were classified as having DSM-5 insomnia disorder, which includes patients with ‘episodic’ (1-2 months) or ‘persistent’ (≥ 3 months) courses per DSM-5 specifiers.

Insomnia Severity Index (ISI)

measured global insomnia symptom severity,^53,58 which was the primary end-point for sleep in this trial. Scores range from 0 to 28 with higher scores reflecting greater insomnia severity. ISI ≥ 11 indicates clinically significant insomnia symptoms and yields excellent sensitivity (.789) and outstanding specificity (.937) for detecting DSM-5 insomnia disorder in pregnancy.^7,58 Per standard practice, treatment remission was defined as ISI ≤ 7, which has been empirically supported for detecting good sleep in pregnancy.^7,58

The Edinburgh Postnatal Depression scale

was used to assess depression.⁵⁹ EPDS scores range from 0 to 30 with higher scores indicating greater depression. EPDS scores ≥ 10 cutoff yields good sensitivity and specificity for detecting minor and major depression. Moreover, Henry Ford Health women’s health clinics use the EPDS ≥ 10 cutoff to refer pregnant and postpartum women for further depression evaluation and potential treatment.

The Pre-Sleep Arousal Scale’s Cognitive factor (PSASC)

is a transdiagnostic measure of nocturnal cognitive arousal.⁵⁵ PSASC scores range from 8 to 40 with higher scores indicating greater cognitive arousal while trying to fall asleep (e.g., ‘can’t shut off your thoughts’). PSASC ≥ 18 is a validated cutoff for detecting high nocturnal cognitive arousal in pregnancy.⁷

Nocturnal perinatal-focused rumination

was assessed via an appended item to the PSASC, which has been utilized in previous studies.^12,15,16 The item asks pregnant women how intensely they ‘worried or had stressful thoughts about your pregnancy or new infant’ when attempting to fall asleep. Scores range from 1 to 5 with higher scores indicating greater perinatal-focused rumination at night.

The Glasgow Sleep Effort Scale (GSES)

is a 7-item self-report survey of sleep effort during the past week.⁵⁶ The GSES taps cognitive arousal (‘I worry about not sleeping if I cannot sleep’), dysfunctional beliefs about sleep (‘I feel I should be able to control my sleep’), and maladaptive behaviors in response to anticipated sleep problems (‘I put off going to bed at night for fear of not being able to sleep’). GSES scores range from 0 to 21 with higher scores indicating greater sleep effort.

The Consumer’s Report Treatment Satisfaction Scale (CRTSS)⁶⁰

was adapted for insomnia by Manber et al.⁶¹ The CRTSS asks “How much do you feel the insomnia treatment program has helped you in the following areas?” We retained the following areas from Manber’s adaptation: insomnia, energy level, life enjoyment, hopefulness, self-esteem, and mood. We modified ‘coping’ to be ‘coping with stress,’ and replaced ‘work productivity’ with ‘stress related to pregnancy.’ Patients rated each area on a 5-point scale: 1 = Made things a lot worse, 2 = Made things somewhat worse, 3 = Made no difference, 4 = Made things somewhat better, and 5 = Made things a lot better.

Helpful and Unhelpful PUMAS components

were indicated after treatment by patients. Specifically, patients were provided with the following list of components and were asked to select checkboxes for the components they found most helpful and the least helpful: Meditations, sleep restriction, stimulus control, mindful activities, pleasant events diary, unpleasant events diary, the PUMAS app, and telemedicine video format of therapy.

Self-efficacy in mindfulness meditation

was assessed after treatment. Specifically, we asked patients: (1) How confident do you feel in your ability to meditate after practicing with the PUMAS app throughout the program? And (2) How skilled in mindfulness do you feel that you are after practicing with the PUMAS app throughout the program? Self-efficacy items were rated on a 1 to 5 scale including (1) not at all, (2) slightly, (3) somewhat, (4) quite, and (5) extremely confident/skilled in meditation.

Analysis Plan

Study outcomes were downloaded from Qualtrics. Analyses were performed in SPSS version 26 (IBM Corp) with a significance value of .05. We first examined descriptive data for sample characteristics, including sociodemographics and presenting clinical symptoms. Study hypotheses regarding efficacy first tested using intent-to-treat (ITT) analyses, which included all patients enrolled in PUMAS. Specifically, we conducted paired samples t-tests to test pretreatment to posttreatment effects of PUMAS on insomnia, depression, nocturnal cognitive arousal, and sleep effort. Paired samples t-test effect sizes are expressed using Cohen’s dz; small=.20, medium=.50, large=.80, very large ≥1.00 (Cohen’s dz is an effect size for change scores in repeated measures designs⁶²).

Finally, we evaluated patient feedback regarding treatment satisfaction, self-efficacy, and rating components of the program as helpful and unhelpful. We provided descriptive summary data for treatment satisfaction via responses to the CRTSS. In addition, we reported frequency data for PUMAS components that patients rated as most and least helpful, as well as patient self-efficacy data for descriptive purposes.

RESULTS

Patient characteristics.

Sample characteristics are reported in Table 3. Our sample consisted of 12 pregnant women aged 22 to 36 years, all of whom were in the second trimester at baseline screening (gestational week range: 21-27 weeks). All patients were either married or in a committed relationship. Most pregnancies were planned, 2/3 of the sample was nulliparous, and 41.7% of women in the study reported having other kids in the home. Two patients reported having hypertension, whereas no patients reported having diabetes.

Table 3.

Patient characteristics at baseline.

Age (M±SD, range)	30.33±4.23, 22-36 years	Education level
Gestational week (M±SD, range)	23.67±1.97, 21-27 weeks	Some college credit, but no degree	n=1/12, 8.3%
Relationship status (n, %)		Trade, technical, or vocational certificate	n=1/12, 8.3%
Married	n=11/12, 91.7%	Bachelor’s degree	n=6/12, 50.0%
Not married, but in a relationship	n=1/12, 8.3%	Master’s degree	n=4/12, 33.3%
Planned pregnancy (n, %)	n=9/12, 75.0%	Employment status (n, %)
Nulliparous (n, %)	n=8/12, 66.7%	Full-time	n=8/12, 66.7%
Other kids at home	n=5/12, 41.7%	Part-time	n=2/12, 16.7%
BMI (M±SD, range)	29.98±4.50, 21.80-39.00	Stay-at-home parent or homemaker	n=2/12, 16.7%
BMI ≥ 35 (n, %)	n=1/12, 8.3%	Annual household income (n, %)
Hypertension (n, %)		< $20,000	n=3/12, 25.0%
Gestational onset	n=1/12, 8.3%	$75,001 - $100,000	n=6/12, 50.0%
Pre-gestational onset	n=1/12, 8.3%	$100,001 - $200,000	n=2/12, 16.7%
Diabetes, type II (n,%)	n=0/12, 0.0%	> $200,000	n=1/12, 8.3%
Race (n, %)		DSM-5 insomnia disorder (n, %)
white	n=9/12, 75.0%	Chronic: Met criteria, duration ≥ 3 months	n=11/12, 91.7%
Black	n=1/12, 8.3%	Episodic: Met criteria, duration = 2 months	n=1/12, 8.3%
East or Southeast Asian	n=1/12, 8.3%	Sleep duration (M±SD)	6.67±.96 hours
Multi-racial	n=1/12, 8.3%	≤ 6 hours/night (n, %)	n=3/12, 25.0%
		Habitual snoring (≥ 3 nights/week; n, %)	n=2/12, 16.7%
		Antidepressant medication (n, %)	n=1/12, 8.3%
		Sleep aids (n, %)	n=0/12, 0.0%

Note: M±SD = mean and standard deviation. n = number of patients. % = percentage of patients. BMI = body mass index.

The sample predominantly self-identified racially as non-Hispanic white (75.0%). Patients were highly educated with 83.3% having a 4-year college degree or higher level of education. Half of the sample reported an annual household between $75,001 and $100,000, whereas a quarter of the sample reported annual household income of less than $20,000.

All 12 patients met diagnostic criteria for DSM-5 insomnia disorder. Of these 12 women, 11 patients met the ≥ 3-month duration for persistent insomnia, whereas 1 patient reported symptoms lasting 2 months for episodic insomnia. No patients reported taking prescription, over-the-counter, or dietary supplement sleep aids. See Table 3 for more baseline sleep characteristics.

PUMAS session attendance and adherence to guided meditations

Session attendance.

See Table 4 for session attendance. Eleven of 12 (91.7%) PUMAS patients completed all six sessions, whereas one patient withdrew from treatment after two sessions due to an unexpected major life event that logistically precluded her ability to remain in therapy. Notably, the patient who discontinued treatment provided posttreatment data for the primary study outcomes (insomnia, depression, nocturnal cognitive arousal, and sleep effort) a week after her final session but did not provide treatment feedback.

Table 4.

PUMAS engagement and adherence metrics.

Number of sessions attended
2 sessions (n,%)	1/12, 8.3%
6 sessions (n,%)	11/12; 91.7%
At-home guided meditations
Days per week (M±SD)	6.08±1.78
1 days per week (n,%)	1/12; 8.3%
5 days per week (n,%)	2/12; 16.7%
6 days per week (n, %)	1/12; 8.3%
7 days per week (n,%)	11/12; 57.9%
Minutes per day (M±SD)	20.00±9.05
10 minutes per day (n,%)	3/12; 25.0%
15 minutes per day (n,%)	2/12; 16.7%
20 minutes per day (n,%)	4/12; 33.3%
30 minutes per day (n,%)	1/12; 8.3%
35 minutes per day (n,%)	2/12; 16.7%

Note: M±SD = mean and standard deviation. n = number of patients. % = percentage of patients.

Meditation adherence.

See Table 4 for adherence metrics. Over half of patients reported meditating at home seven days per week during therapy (M±SD: 6.08±1.78). Only one patient meditated fewer than 5 days per week. On average, patients reported meditating an average of 20 minutes per day (range: 10-35 minutes).

PUMAS effects on insomnia, depression, nocturnal cognitive arousal, nocturnal perinatal-focused rumination, and sleep effort.

Insomnia symptoms.

Before PUMAS, all patients reported ISI scores ≥ 11 with a mean of 14.50±2.50. After PUMAS, mean ISI scores decreased to 3.67±3.11, representing a mean reduction of 10.83 points on the ISI. An ITT paired samples t-test revealed a significant reduction in ISI scores for PUMAS patients (t[11]=−10.45, p<.001), which corresponded to a very large effect (Cohen’s dz=3.05). At posttreatment, n=10/12 (83.3%) of patients remitted on insomnia (ISI≤7). When evaluating only patients who received an adequate dose of PUMAS (≥ 4 sessions), n=10/11 (90.9%) of PUMAS patients remitted from insomnia.

Depression symptoms.

Before PUMAS, mean EPDS scores were 8.67±5.33, which neared the clinical cutoff for minor and major depression. After PUMAS, mean EPDS scores decreased to 3.42±2.75, representing a mean reduction of 5.25 points on the EPDS. An ITT paired samples t-test revealed a significant reduction in EPDS scores for PUMAS patients (t[11]=−4.16, p=.002), which corresponded to a very large effect (Cohen’s dz=1.41).

To evaluate preliminary efficacy of PUMAS on depression symptoms in prenatal insomnia patients with comorbid depression, we reran the analysis in only those who reported EPDS scores ≥ 10 at baseline. Before PUMAS treatment, n=5/12 (41.7%) of patients screened positive for comorbid depression with an EPDS mean of 14.00±3.32. After PUMAS, mean EPDS scores in this comorbid depression group decreased to 5.00±2.55, representing a mean reduction of 9.00 points on the EPDS. An ITT paired samples t-test revealed a significant reduction in EPDS scores in this baseline depressed subgroup (t[4]=−6.07, p=.004), which corresponded to a very large effect (Cohen’s dz=2.76). All five of these patients remitted from depression (EPDS<10) after PUMAS treatment.

Nocturnal cognitive arousal.

Before PUMAS, n=8/12 (75.0%) screened positive for high nocturnal cognitive arousal (PSASC≥18) and mean PSASC scores were 20.75±4.58. After PUMAS, mean PSASC scores decreased to 12.50±4.23, representing a mean reduction of 8.25 points on the PSASC. An ITT paired samples t-test revealed a significant reduction in PSASC scores (t[11]=−7.18, p<.001), which corresponded to a very large effect (Cohen’s dz=2.08). After treatment, only one patient (8.3%) continued to report high cognitive arousal.

Nocturnal perinatal-focused rumination.

Before PUMAS, the mean perinatal rumination score was 3.08±.67, corresponding to moderate levels of rumination at night. After PUMAS, mean scores decreased to 1.75±.62, corresponding to rumination intensity levels between ‘not at all’ and ‘slightly.’ An ITT paired samples t-test revealed a significant reduction in perinatal-focused rumination (t[11]=−7.09, p<.001), which corresponded to a very large effect (Cohen’s dz=2.05).

Sleep effort.

Before PUMAS, mean GSES scores were 5.92±2.64, which decreased to 2.08±1.62 after treatment; a mean reduction of 3.83 points. An ITT paired samples t-test revealed a significant reduction in GSES scores (t[11]=−6.38, p<.001), which corresponded to a very large effect (Cohen’s dz=2.06).

Posthoc: Do patient outcomes differ based on clinician background?

When comparing patients who were treated by a psychologist (n=8) vs those treated by a registered nurse (n=4), patient outcomes (operationalized as change scores from pretreatment to posttreatment) did not differ for insomnia (p=.791), depression (p=.600), nocturnal cognitive arousal (p=.235), perinatal-focused rumination (p=.770), or sleep effort (p=.927).

Posthoc: Do patients with baseline depression have poorer treatment outcomes?

As depression comorbidity affects approximately half of prenatal insomnia cases, we explored whether clinical presentations differed at treatment enrollment, and tested whether treatment outcomes differed between groups. See Supplement for detailed methods and results. Before PUMAS, patients with comorbid depression reported greater nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort relative to non-depressed patients (Table S1). Further analyses revealed that PUMAS produced very large effects on all study outcomes in depressed patients (Table S2). After PUMAS, patients with and without baseline comorbid depression did not differ on insomnia symptoms, depression, nocturnal cognitive arousal, and perinatal-focused rumination, whereas residual sleep effort persisted in formerly depressed patients (Table S3).

PUMAS treatment satisfaction and patient feedback.

Treatment satisfaction.

Patients were highly satisfied with treatment gains in insomnia (100% reported improvement), energy levels (90.9% reported improvement), stress related to pregnancy (90.9% reported improvement), and mood (90.9% reported improvement). See Table 6 for treatment satisfaction frequency data.

Table 6.

Treatment satisfaction and patient feedback (n=11).

CRTSS	A lot worse	Somewhat worse	No difference	Somewhat better	A lot better
Insomnia	0; 0.0%	0; 0.0%	0; 0.0%	2; 18.2%	9; 81.8%
Energy level	0; 0.0%	0; 0.0%	1; 9.1%	5; 45.5%	5; 45.5%
Pregnancy stress	0; 0.0%	0; 0.0%	1; 9.1%	4; 36.4%	6; 54.5%
Coping with stress	0; 0.0%	0; 0.0%	2; 18.2%	2; 18.2%	7; 63.6%
Life enjoyment	0; 0.0%	0; 0.0%	3; 27.3%	1; 9.1%	7; 63.6%
Hopefulness	0; 0.0%	0; 0.0%	2; 18.2%	2; 18.2%	7; 63.6%
Self-esteem	0; 0.0%	0; 0.0%	2; 18.2%	4; 36.4%	5; 41.7%
Mood	0; 0.0%	0; 0.0%	1; 9.1%	2; 27.3%	7; 63.6%
PUMAS component	Helpful (n, %)	Unhelpful (n, %)	Self-efficacy (n, %)
Sleep restriction	11; 100%	0; 0.0%	Confident in ability to meditate
Telemedicine	9; 81.8%	0; 0.0%	Slightly		2; 18.2%
PUMAS app	8; 72.7%	1; 9.1%	Quite		4; 36.4%
Meditations	8; 72.7%	2; 18.2%	Extremely		5; 45.5%
Mindful activities	4; 36.4%	2; 18.2%	Skilled in meditation
Stimulus control	3; 27.3%	5; 45.5%	Somewhat		4; 36.4%
Pleasant events diary	3; 27.3%	5; 45.5%	Quite		4; 36.4%
Unpleasant events diary	2; 18.2%	7; 63.6%	Extremely		3; 27.3%

Note: CRTSS = Consumer’s report treatment satisfaction scale modified for perinatal insomnia. Self-efficacy items were rated on a 1 to 5 scale including (1) not at all, (2) slightly, (3) somewhat, (4) quite, and (5) extremely confident/skilled in meditation.

Helpful and unhelpful components.

SRT was universally identified as a helpful component of PUMAS (100% endorsed as helpful). Other highly touted PUMAS components included telemedicine format of therapy (81.8% endorsed as helpful), guided meditations (72.7% endorsed as helpful), and the PUMAS app (72.7% endorsed as helpful). By comparison, mindful activities, stimulus control, and the pleasant and unpleasant events diaries received more mixed helpfulness ratings. See Table 6 for PUMAS component ratings.

Self-efficacy.

After completing the program, 81.8% of patients reported feeling ‘quite’ or ‘extremely’ confident in their ability to meditate, and 63.6% of patients reported feeling ‘quite’ or ‘extremely’ skilled in mindfulness meditation. See Table 6 for self-efficacy frequency data.

DISCUSSION

The present study was a single-arm proof-of-concept trial examining patient engagement, acute treatment effects, and patient-reported satisfaction and feedback for PUMAS, a mindfulness-based intervention imbued with behavioral sleep strategies tailored for pregnant women. Patients were highly engaged in PUMAS, which was delivered individually via telemedicine video by a psychologist or nurse. ITT analyses revealed large treatment effects on insomnia symptoms, depression symptoms, nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort. After completing the PUMAS program, patients reported high treatment satisfaction across several domains of functioning and quality of life. Taken together, PUMAS may represent a viable treatment option for prenatal insomnia, including patients with comorbid depression.

Patients are highly engaged in the PUMAS program

Over 90% of patients completed all six PUMAS sessions, indicating high patient engagement. Only one patient withdrew from treatment, which was due to an unforeseen major life event that precluded her ability to continue attending therapy after two sessions. High attendance was likely supported by the telemedicine format as reflected by 81.8% of patients identifying it as a helpful aspect of treatment delivery. Indeed, a prior study by our team (before the COVID-19 pandemic) showed that >80% of pregnant women with insomnia preferred telemedicine treatment over in-person therapy.²⁶ Given the equivalent effectiveness of telemedicine and in-person insomnia therapy,^63,64 telemedicine delivery increases access to insomnia therapy without sacrificing quality of care.⁶⁵

A critical aspect of PUMAS delivery in this study was its individual format wherein one patient works with a clinician. MBIs are traditionally delivered in group formats, which is reflected in the literature as clinical trials tend to evaluate only group-based MBIs.⁶⁶ Although mindfulness training in groups has clear benefits (cost effectiveness, learning mindfulness in a community context),⁶⁶ our clinical trial results suggest that a group format is not essential for PUMAS or likely other similar MBIs (e.g., MBTI) to be efficacious. Individual formats have unique benefits, including flexible scheduling, more personalized treatment, and better alignment with some patients’ preferences. Indeed, a large study examining patients’ MBI preferences showed that individual format was preferred over group formats.⁶⁷ Thus, the present study offers critical preliminary support for offering MBIs in individual formats when circumstances and patient preferences align for doing so.

Meditation practice is central to MBIs. In the present study, patients were asked to meditate daily using guided meditations using the provided PUMAS app. We observed that >90% of patients reported meditating at least five days per week with over half of patients meditating daily. Moreover, patients reported meditating an average of 20 minutes per day. Taken together, these data indicate good patient engagement in establishing a daily meditation practice.

Preliminary efficacy of PUMAS

Insomnia.

Notably, all patients were recruited in the late second trimester and received care while entering the third trimester. Given that insomnia prevalence and severity increases across pregnancy, we aimed to treat women the most need of prenatal insomnia care. ITT analyses revealed that PUMAS patients reported a mean reduction of 10.83 points on the ISI, resulting in 83.3% of patients remitting from insomnia. These trial data preliminarily support efficacy of PUMAS for prenatal insomnia. The observed magnitude of insomnia alleviation was larger than observations in previous clinical trials treating prenatal insomnia with clinician-led CBTI (ISI reduction of 7.40 points)²⁰ and a fully automated digital CBTI program (ISI reduction of 4.91 points).²³ Reflecting the magnitude of this effect, our observed remission rate of 83.3% was higher than insomnia remission rates produced by clinician-led CBTI (63.8%)²⁰ and digital CBTI (34.8% - 44.0%).^22,23 Mind that we are simply reporting descriptive statistics here, whereas a comparative efficacy RCT would be needed to test whether PUMAS and CBTI produce different patient outcomes.

Nocturnal cognitive arousal and perinatal-focused rumination.

Given the insomniogenic effects of high nocturnal cognitive arousal, reducing cognitive arousal has been proposed to enhance insomnia therapy outcomes.^12,25,28,45 Unfortunately, extant clinical trial data indicate that CBTI produces no clinically meaningful benefit for these symptoms during pregnancy.^23,26 To address this limitation of CBTI, enhancing insomnia therapy with mindfulness has been proposed to improve reduction in cognitive arousal symptoms.^12,25,28 Indeed, clinical trial data from the non-perinatal insomnia patient population shows insomnia therapy that combines behavioral sleep strategies and mindfulness meditation produces large reductions in nocturnal cognitive arousal.^35,37

In the present study, PUMAS produced very large reductions in nocturnal cognitive arousal and perinatal-focused rumination. Before treatment, 75.0% of patients screened positive for high cognitive arousal (PSASC ≥ 18), but this frequency rate decreased to 8.3% after PUMAS. These large reductions in nocturnal cognitive arousal and perinatal-focused rumination contrast with a previous CBTI trial which revealed no significant reductions in cognitive arousal, rumination, or worry in prenatal insomnia patients.^23,26 Taken together, these data preliminarily support combining mindfulness meditation with behavioral sleep strategies to enhance alleviation of cognitive arousal symptoms in prenatal insomnia.

Sleep effort

has been described as ‘effortful preoccupation with sleep’ that perpetuates insomnia.⁵⁶ Sleep effort is comprised of behavioral and cognitive elements.⁵⁶ Behaviorally, sleep effort may manifest as delaying bedtime for fear of inability to sleep. Cognitively, sleep effort may manifest as dysfunctional beliefs about sleep (e.g., “I am no good at sleeping”) and as heightened cognitive arousal (e.g., sleep-focused worry). Clinical trial data from the general insomnia population shows that sleep effort is successfully reduced with behavioral sleep strategies⁶⁸ and MBTI.^35,37 No published clinical trials in prenatal insomnia have reported sleep effort outcomes.

Owing to the role of cognitive arousal in sleep effort, we tested sleep effort as an outcome in PUMAS. Findings revealed that PUMAS substantially reduced sleep effort. One possible pathway from PUMAS to reductions in sleep effort may involve the mindfulness principle of ‘non-striving.’ Congruent with this principle, the PUMAS program emphasizes creating the right conditions for sleep then letting go, rather than promoting behaviors that strive for sleep.

Depression.

Consistent with larger studies of pregnant women with insomnia,^7,12 nearly half of pregnant women with DSM-5 insomnia in the present trial screened positive for comorbid depression at baseline. Study findings support PUMAS as efficacious in reducing comorbid depressive symptoms as indicated by a mean EPDS reduction of 5.25 points in the full sample, which corresponded to a very large effect. Importantly, CBTI trials have produced modest antidepressant effects for both clinician-led therapy (EPDS reduction of 3.4 points, corresponding to a small effect of Cohen’s d=.15)²⁰ and digital therapy (EPDS reduction of 1.59 points, which was non-significant).²³

Among the subgroup of patients with clinically elevated depression (n=5), PUMAS produced a mean EPDS reduction of 9.00 points, corresponding to a very large effect. Moreover, all five PUMAS patients with baseline depression remitted from depression after treatment, offering strong preliminary support for the antidepressant effects of PUMAS for pregnant women with insomnia and comorbid depression.

Preliminary efficacy of PUMAS for patients with comorbid depression.

Given the high rate of comorbid depression in prenatal insomnia, we not only examined the antidepressant effects of PUMAS in the depressed subgroup, but we also explored whether PUMAS was efficacious for alleviating sleep and cognitive arousal in depressed patients.

Depressed patients presented to treatment with higher levels of cognitive arousal, perinatal-focused rumination, and sleep effort than prenatal insomnia patients without depression. Despite greater cognitive-emotional symptoms before treatment, PUMAS was highly efficacious for depressed patients producing large reductions in insomnia, cognitive arousal, rumination, and sleep effort. After completing PUMAS, patients with baseline comorbid depression no longer differed from non-depressed patients on insomnia, cognitive arousal, or perinatal-focused rumination, thereby further supporting the preliminary efficacy of PUMAS for normalizing these symptoms in depressed prenatal insomnia patients. However, depressed patients continued reporting higher levels of sleep effort than non-depressed patients after PUMAS treatment, despite large reductions in sleep effort and remission of insomnia and depression. This suggests that modifications to better decrease sleep may enhance PUMAS patient outcomes, particularly for depressed patients.

Treatment satisfaction and feedback

Treatment satisfaction.

All patients indicated that PUMAS improved their sleep with most patients rating their sleep as ‘a lot better.’ Most patients also reported high satisfaction regarding improvement in energy levels, pregnancy stress, coping, mood, and all other domains of function measured (all domains listed in Table 6). No patients reported any worsening of function in any domain.

Which PUMAS components were rated as helpful?

Most patients rated the telemedicine therapy format and the PUMAS app as helpful aspects of treatment delivery. Regarding treatment components, all PUMAS patients rated modified SRT as a helpful component of PUMAS and most patients rated the guided meditations as helpful. By comparison, mindful activities, stimulus control, and the pleasant events diary received mixed helpfulness ratings, whereas the unpleasant events diary was rated as unhelpful by more than half the sample.

Self-efficacy.

The extant literature supports continued mindfulness practice to maintain health benefits over the long-term.⁶⁹ Although the present proof-of-concept trial did not assess long-term effects, we asked patients to rate their self-efficacy in mindful meditation, which may help promote longer-term meditation practice. After PUMAS, >80% of patients reported high levels of confidence in their ability to meditate and >60% rated themselves as highly skilled in meditation. Future studies should (a) examine whether meditation self-efficacy predicts future long-term practice and (b) determine strategies for maximizing meditation self-efficacy and promoting long-term meditation practice for patients who complete MBIs.

Study limitations

The present study should be interpreted in light of methodological limitations that are inherent but appropriate to proof-of-concept trials. The first limitation pertains to the reliance on patient estimates of time spent meditating, which may be biased and do not reflect daily or weekly fluctuations in meditation habits. A goal of this proof-of-concept study was to test and continue to develop the PUMAS app (a repository for the guided meditations), and the app was not capable of capturing patient-time spent listening to the guided meditations during this trial. Secondly, the modest sample size is a limitation, even if appropriate of proof-of-concept trials. Given the multiple comparisons in the present study (five primary end-points including the ISI, EPDS, PSASC, GSES, and perinatal rumination), further research is needed to evaluate these treatment effects for PUMAS.

We also acknowledge limits to population representativeness based on two characteristics of our sample. First, the patient sample was 75.0% non-Hispanic white, which exceeds white representation relative to our previous insomnia clinical trial in pregnancy²³ and even our non-intervention sleep studies in pregnancy.^7,12 Second, access to an iOS device was an inclusion criterion, which limited representativeness of our sample and may have contributed to oversampling of white and/or affluent women. Future research is needed to test patient engagement and treatment efficacy of PUMAS in a more racially and socioeconomically diverse sample, especially given evidence showing that CBTI underperforms in pregnant women with insomnia who identify racially as Black.⁷⁰ Moreover, PUMAS engagement and efficacy should be tested in patients without access to a meditation repository app to determine how best to deliver guided meditations to these patients and ensure adherence to this critical component of this mindfulness-based sleep program. Third, all patients were recruited from the mid-to-late second trimester resulting in all patients receiving care in the second and third trimester of pregnancy. To optimally guide potential implementation of PUMAS in prenatal care, future research is needed on treatment engagement and efficacy of PUMAS when patients enroll in the first trimester or even early third trimester. Along the lines of implementation, it is notable that the prevalence of obstructive sleep apnea (OSA) and restless legs syndrome (RLS) increase during pregnancy and may be comorbid with insomnia, and thus represent important considerations when treating insomnia in the real-world.⁷¹ Research is needed to determine the efficacy of PUMAS in patients presenting with comorbid OSA or RLS.

Lastly, a lack of follow-up outcome data into the postpartum period is a limitation. As this proof-of-concept study did not include a control group, we decided not to evaluate postpartum outcomes. Simply put: Without a control group, we would be unable to test effects of prenatal insomnia care on postpartum sleep given myriad postpartum disruptions to maternal sleep associated with nighttime feeds and unconsolidated infant sleep. Notably, in a previous RCT, we observed that untreated pregnant women with insomnia reported decreases in insomnia symptoms during the newborn period simply due to sleep deprivation in early postpartum.²³ Along these lines, a longer-term RCT showed that prenatal CBTI sleep gains do not reappear in postpartum until six months after childbirth, which is when infant and maternal sleep begin to decouple for many families.²⁴

Conclusions and future directions

Our study supports the concept and feasibility of PUMAS to treat pregnant women with DSM-5 insomnia disorder. Patients were highly engaged and adherent to PUMAS, which was efficacious whether delivered by a psychologist or nurse. PUMAS produced large acute effects on insomnia, depression, nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort. Importantly, PUMAS produced large effects on study outcomes even in patients presenting with comorbid depression. Depressed patients reported normalization of insomnia, depression, cognitive arousal, and rumination. After treatment, patients were highly satisfied with the PUMAS program and identified its telemedicine video format and the PUMAS app as positive features of its delivery. Patients rated modified SRT and the guided meditations as the two most helpful components of the program.

Findings from this proof-of-concept study support testing PUMAS in a larger RCT wherein PUMAS can be compared to a control intervention, which will provide a more rigorous test of its efficacy. In addition, a control group would support testing the durability of PUMAS benefits for sleep and other outcomes into and across postpartum. Given that CBTI during pregnancy benefits prenatal and postnatal sleep,^20-24 comparing PUMAS and CBTI during pregnancy may be warranted. Future studies should explore whether certain perinatal insomnia patient profiles may be better triaged to CBTI or a mindfulness-based approach like PUMAS.

Table 5.

PUMAS-related changes in primary study outcomes as tested by paired samples t-tests.

	Pretreatment	Posttreatment	t-statistic, p, Cohen’s dz
Insomnia symptoms (ISI)
Total Score (M±SD)	14.50±2.50	3.67±3.11	t(11)=−10.45, p<.001, dz=3.05
ISI range	12-20	0-10
ITT: Remission (ISI≤7; n,%)	--	10/12, 83.3%	--
PP: Remission (ISI≤7; n,%)	--	10/11, 90.9%	--
Depression symptoms (EPDS; M±SD)
Full sample (n=12)	8.67±5.33	3.42±2.75	t(11)=−4.16, p=.002, dz=1.41
Baseline EPDS≥10 (n=5)	14.00±3.32	5.00±2.55	t(4)=−6.07, p=.004, dz=2.76
Depression remission (EPDS<10; n;%)	--	5/5; 100.0%	--
Nocturnal Cognitive Arousal (PSASC; M±SD)	20.75±4.58	12.50±4.23	t(11)=−7.18, p<.001, dz=2.08
PSASC ≥ 18 (n;%)	9/12; 75.0%	1/12; 8.3%	--
Perinatal-focused rumination (M±SD)	3.08±0.67	1.75±0.62	t(11)=−7.09, p<.001, dz=2.05
Sleep Effort (GSES; M±SD)	5.92±2.64	2.08±1.62	t(11)=−6.38, p<.001, dz=2.06

Note: t-statistic, p, and Cohen’s dz correspond to the test statistic, significance value, and effect size associated with paired samples t-tests. M±SD = mean and standard deviation. n = number of patients. % = percentage of patients. ITT = intent-to-treat analysis. PP = per protocol analysis consisting only of patients who completed at least four sessions of PUMAS. ISI = insomnia severity index. Remission is operationalized as ISI scores of ≤ 7 at posttreatment. EPDS = Edinburgh postnatal depression scale. EPDS ≥ 10 indicates positive screen for minor or major depression. PSASC = pre-sleep arousal scale, cognitive factor. PSASC ≥ 18 indicates high nocturnal cognitive arousal. Perinatal-focused rumination was measured via a single item appended to the PSASC. GSES = Glasgow sleep effort scale.

Highlights.

• PUMAS places behavioral sleep strategies in a mindfulness framework and all treatment components are tailored to pregnancy.

• All pregnant women in this study met diagnostic criteria for DSM-5 insomnia disorder before treatment.

• PUMAS alleviated insomnia, depression, nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort.

• Patients identified sleep restriction and guided meditations as the most helpful components of the PUMAS program.

• Patients identified the telemedicine video format and a meditation app as helpful facilitators of treatment delivery.