Pregnancy Related, Sleep
Conditions
Keywords
pregnancy, sleep, mindfulness
Brief summary
The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50).
Detailed description
Poor sleep quality is highly prevalent during pregnancy, with important implications for maternal and infant health and well-being. Despite this, there is limited research on interventions to improve prenatal sleep, and prior research did not target the specific factors contributing to poor sleep quality in this population. Specifically, pregnant people report that physical symptoms, including discomfort and pain, disturb their sleep. In non-pregnant populations, this pain-sleep relationship is bidirectional, and maladaptive psychological responses to pain further exacerbate poor sleep. Theory and empirical evidence indicate that mindfulness-based interventions may be effective for targeting these psychological responses. The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50). Participants will be recruited to complete study questionnaires at two timepoints during pregnancy. Participants randomized to MBSR+PS will receive usual care, will be asked to attend 8 weekly group MBSR sessions (in addition to the MBSR orientation session, 1:1 interview with the instructor, and daylong retreat) and 6-8 PS sessions individually or in small groups, and will complete daily sleep and home practice diaries. Participants randomized to treatment as usual will receive usual care. The specific aims are: 1. To determine acceptability of MBSR+PS. 2. To determine feasibility of MBSR+PS. 3. To determine adherence to MBSR+PS. 4. To explore evidence of change in psychological mediators. 5. To explore between-group differences in sleep. 6. To explore group differences in other critical clinical outcomes (e.g. depressive symptoms, anxiety symptoms, stress). There is strong conceptual basis to predict the potential benefit of this approach for pregnant people. Targeting psychological responses to poor sleep during pregnancy may have significant public health benefits.
Interventions
BEHAVIORALMindfulness-Based Stress Reduction plus Prenatal Sleep supplement
MBSR+PS
OTHERTreatment as Usual
TAU
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnancy 12-28 weeks gestation at time of intervention start * 18 years of age or older * Regular access to a web-enabled computer, phone or tablet * Ability to read and speak English, and to provide informed consent * Poor sleep quality (PSQI \> 5)
Exclusion criteria
* Self-reported sleep disorder (e.g. sleep apnea, narcolepsy, parasomnia, circadian rhythm disorder) * Shift-work or nighttime caregiving responsibilities * Psychological, medical, or other issues that necessitate priority treatment (e.g. active suicidality, probable depression (PHQ-9 ≥ 10), psychosis, on bed rest, multiple gestation) * Current regular mindfulness practice (\>20 minutes/week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Total Score Greater Than or Equal to 24 on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 12 Weeks | Post-intervention, an average of 12 weeks | The Client Satisfaction Questionnaire (CSQ-8) score ranges from 8 to 32, with high scores indicating greater satisfaction. The CSQ-8 score of participants randomized to MBSR+PS will be reported; participants randomized to TAU will not complete the CSQ-8 as the questions pertain to the MBSR+PS program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Endpoint Measures at 12 Weeks | Post-intervention, an average of 12 weeks | For a measure to be considered complete, at least 95% of items must be completed. |
| Completeness of Study Measures at Baseline and at 12 Weeks | Baseline and post-intervention, an average of 12 weeks | For a measure to be considered complete, at least 95% of items must be completed. Completeness of study measures at baseline and 12 weeks are combined (averaged); the percentage of measures completed across timepoints is reported. |
| Percentage of MBSR and PS Sessions Attended | Baseline to post-intervention, an average of 12 weeks | This measure will not be collected for participants randomized to TAU. |
| Frequency of Home Practices From Baseline to 12 Weeks | Baseline to post-intervention, an average of 12 weeks | Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants randomized to TAU will not complete this measure. |
| Duration of Home Practices From Baseline to 12 Weeks | Baseline to post-intervention, an average of 12 weeks | Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants assigned to TAU will not complete this measure. |
| Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Self Compassion Scale - Short Form (SCS-SF) score ranges from 1 to 5, with higher scores indicating greater self-compassion. The change in SCS-SF score from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | We included two factors of the Five-Facet Mindfulness Questionnaire (FFMQ): the nonjudging factor (score ranges from 8 to 40) and the non-reactivity factors (score ranges from 7 to 35). Higher scores indicate greater mindfulness. The change in factor scores from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Coping Strategies Questionnaire - Revised (CSQ-R) score ranges from 0 to 36 on each of the 7 subscales, with higher scores indicating greater use of a coping strategy. The change in CSQ score from baseline to post-intervention (at 12 weeks) will be reported. |
| Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks | Baseline to post-intervention, an average of 12 weeks | Participants can attend 0-8 sessions of MBSR and of PS. |
| Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21. A total score of 5 or more indicates poor sleep quality; the higher the score, the worse the sleep quality. The change in PSQI score from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity. The change in ISI score from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Dysfunctional Beliefs About Sleep (DBAS) score ranges from 0 to 10, with a score of 4 or greater indicating unrealistic expectations for sleep, and greater scores indicating more dysfunctional beliefs about sleep. The change in DBAS score from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Measures for coping with sleep disturbances score ranges from 0 to 11, with greater scores indicating greater use of active coping measures for sleep disturbance. The change in Measures for coping with sleep disturbances score from baseline to post-intervention (at 12 weeks) will be reported. |
| Worry About Sleep Duration | Post-intervention, an average of 12 weeks | Single item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks. |
| Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks | Baseline to post-intervention, an average of 12 weeks | The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with a score greater than or equal to 10 indicating moderate to severe depression, and the higher the score, the greater the depressive symptom severity. The change in PHQ-9 score from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The PROMIS 6-item anxiety score ranges from 6 to 30, with higher scores indicating more severe anxiety; from raw scores, standardized T-scores can be determined. The change in PROMIS 6-item anxiety T-score from baseline to post-intervention (at 12 weeks) will be reported. The T-score values have a mean = 50 and SD = 10, with higher scores indicating greater anxiety. The T-scores are interpreted as follows: Less than 55 = None to slight anxiety 55.0-59.9 = Mild anxiety 60.0-69.9 = Moderate anxiety 70 and over = Severe anxiety |
| Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating greater appraisal of stress. The change in PSS score from baseline to post-intervention (at 12 weeks) will be reported. |
| Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks | Baseline and post-intervention, an average of 12 weeks | The Rumination-Reflection Questionnaire (RRQ) score ranges from 12 to 60 for each of the two factors. Greater scores indicate greater tendency to ruminate and reflect. The change in RRQ score from baseline to post-intervention (at 12 weeks) will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) The study intervention is standard mindfulness-based stress reduction (MBSR), which will be delivered through 8 weekly 2.5-hour sessions via video conferencing to groups of 20-30 pregnant and non-pregnant people. MBSR also consists of a 2.5-hour orientation session, a 30-minute private interview with the instructor, and an all-day retreat, all conducted via video conferencing. The supplemental prenatal sleep content will be delivered through 6-8 30-minute sessions via video conferencing either individually or to small groups, and draws material from mindfulness-based therapy for insomnia, mindfulness-based childbirth and parenting program, and cognitive behavior therapy for prenatal insomnia.
Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement: MBSR+PS
Treatment as Usual: TAU | 26 |
| Treatment as Usual The control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy, with the exception of asking participants to refrain from participating in non-study mindfulness practice. Use of non-study treatment will be tracked.
Treatment as Usual: TAU | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 33.31 years STANDARD_DEVIATION 5.02 | 31.85 years STANDARD_DEVIATION 5.45 | 32.58 years STANDARD_DEVIATION 5.24 |
| Pittsburgh Sleep Quality Index (PSQI) Score | 7.12 units on a scale STANDARD_DEVIATION 2.57 | 7.15 units on a scale STANDARD_DEVIATION 1.74 | 7.13 units on a scale STANDARD_DEVIATION 2.17 |
| Race/Ethnicity, Customized African American or Black | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Bi- or multi-racial or -ethnic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian, White, or European American | 13 Participants | 16 Participants | 29 Participants |
| Race/Ethnicity, Customized Latina, Latin American, or Hispanic | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 8 / 26 | 7 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Number of Participants With a Total Score Greater Than or Equal to 24 on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 12 Weeks
The Client Satisfaction Questionnaire (CSQ-8) score ranges from 8 to 32, with high scores indicating greater satisfaction. The CSQ-8 score of participants randomized to MBSR+PS will be reported; participants randomized to TAU will not complete the CSQ-8 as the questions pertain to the MBSR+PS program.
Time frame: Post-intervention, an average of 12 weeks
Population: The overall number of participants analyzed (n=23) is one lower than reported in the participant flow module because one participant skipped the items for this measure but completed the majority of the other endpoint surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Number of Participants With a Total Score Greater Than or Equal to 24 on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 12 Weeks | 20 Participants |
Secondary
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
The Coping Strategies Questionnaire - Revised (CSQ-R) score ranges from 0 to 36 on each of the 7 subscales, with higher scores indicating greater use of a coping strategy. The change in CSQ score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Distracting score | .38 units on a scale | Standard Deviation 0.73 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Catastrophizing score | -.36 units on a scale | Standard Deviation 0.58 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Ignoring score | -.25 units on a scale | Standard Deviation 1.03 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Distancing score | .54 units on a scale | Standard Deviation 1.34 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Coping score | -.08 units on a scale | Standard Deviation 0.93 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Praying score | .04 units on a scale | Standard Deviation 0.95 |
| Treatment as Usual | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Coping score | -.05 units on a scale | Standard Deviation 0.97 |
| Treatment as Usual | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Distracting score | -.09 units on a scale | Standard Deviation 0.98 |
| Treatment as Usual | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Distancing score | .41 units on a scale | Standard Deviation 0.98 |
| Treatment as Usual | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Catastrophizing score | -.14 units on a scale | Standard Deviation 1.04 |
| Treatment as Usual | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Praying score | .33 units on a scale | Standard Deviation 1.09 |
| Treatment as Usual | Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks | Ignoring score | .03 units on a scale | Standard Deviation 1.21 |
Secondary
Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks
The Dysfunctional Beliefs About Sleep (DBAS) score ranges from 0 to 10, with a score of 4 or greater indicating unrealistic expectations for sleep, and greater scores indicating more dysfunctional beliefs about sleep. The change in DBAS score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks | -1.11 units on a scale | Standard Deviation 1.15 |
| Treatment as Usual | Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks | -.96 units on a scale | Standard Deviation 1.24 |
Secondary
Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks
We included two factors of the Five-Facet Mindfulness Questionnaire (FFMQ): the nonjudging factor (score ranges from 8 to 40) and the non-reactivity factors (score ranges from 7 to 35). Higher scores indicate greater mindfulness. The change in factor scores from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks | Nonjudging score | 2.00 units on a scale | Standard Deviation 4.17 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks | Nonreacting score | 2.04 units on a scale | Standard Deviation 5.15 |
| Treatment as Usual | Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks | Nonjudging score | 1.58 units on a scale | Standard Deviation 5.72 |
| Treatment as Usual | Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks | Nonreacting score | 1.46 units on a scale | Standard Deviation 4.2 |
Secondary
Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks
The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity. The change in ISI score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks | -5.29 units on a scale | Standard Deviation 4.09 |
| Treatment as Usual | Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks | -4.17 units on a scale | Standard Deviation 4.06 |
Secondary
Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks
The Measures for coping with sleep disturbances score ranges from 0 to 11, with greater scores indicating greater use of active coping measures for sleep disturbance. The change in Measures for coping with sleep disturbances score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
Population: Data were not collected for this measure.
Secondary
Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks
The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with a score greater than or equal to 10 indicating moderate to severe depression, and the higher the score, the greater the depressive symptom severity. The change in PHQ-9 score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline to post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks | -1.78 units on a scale | Standard Deviation 2.7 |
| Treatment as Usual | Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks | -1.38 units on a scale | Standard Deviation 3.02 |
Secondary
Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks
The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating greater appraisal of stress. The change in PSS score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks | -1.83 units on a scale | Standard Deviation 3.93 |
| Treatment as Usual | Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks | -2.46 units on a scale | Standard Deviation 5.14 |
Secondary
Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks
The Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21. A total score of 5 or more indicates poor sleep quality; the higher the score, the worse the sleep quality. The change in PSQI score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks | -2.58 units on a scale | Standard Deviation 2.21 |
| Treatment as Usual | Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks | -1.79 units on a scale | Standard Deviation 2.06 |
Secondary
Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks
The PROMIS 6-item anxiety score ranges from 6 to 30, with higher scores indicating more severe anxiety; from raw scores, standardized T-scores can be determined. The change in PROMIS 6-item anxiety T-score from baseline to post-intervention (at 12 weeks) will be reported. The T-score values have a mean = 50 and SD = 10, with higher scores indicating greater anxiety. The T-scores are interpreted as follows: Less than 55 = None to slight anxiety 55.0-59.9 = Mild anxiety 60.0-69.9 = Moderate anxiety 70 and over = Severe anxiety
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks | -1.45 T-score | Standard Deviation 7.79 |
| Treatment as Usual | Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks | -2.32 T-score | Standard Deviation 7.55 |
Secondary
Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks
The Rumination-Reflection Questionnaire (RRQ) score ranges from 12 to 60 for each of the two factors. Greater scores indicate greater tendency to ruminate and reflect. The change in RRQ score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks | Rumination score | -1.46 units on a scale | Standard Deviation 6.85 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks | Reflection score | .96 units on a scale | Standard Deviation 3.85 |
| Treatment as Usual | Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks | Rumination score | -2.75 units on a scale | Standard Deviation 5.84 |
| Treatment as Usual | Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks | Reflection score | -.13 units on a scale | Standard Deviation 5.04 |
Secondary
Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks
The Self Compassion Scale - Short Form (SCS-SF) score ranges from 1 to 5, with higher scores indicating greater self-compassion. The change in SCS-SF score from baseline to post-intervention (at 12 weeks) will be reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks | 1.12 units on a scale | Standard Deviation 5.64 |
| Treatment as Usual | Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks | 2.71 units on a scale | Standard Deviation 7.57 |
Secondary
Completeness of Study Measures at Baseline and at 12 Weeks
For a measure to be considered complete, at least 95% of items must be completed. Completeness of study measures at baseline and 12 weeks are combined (averaged); the percentage of measures completed across timepoints is reported.
Time frame: Baseline and post-intervention, an average of 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Completeness of Study Measures at Baseline and at 12 Weeks | 95.2 percentage of measures completed |
| Treatment as Usual | Completeness of Study Measures at Baseline and at 12 Weeks | 96.1 percentage of measures completed |
Secondary
Duration of Home Practices From Baseline to 12 Weeks
Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants assigned to TAU will not complete this measure.
Time frame: Baseline to post-intervention, an average of 12 weeks
Population: Participants randomized to MBSR+PS. The participant flow module lists n=24 analyzed because 24 participants completed endpoint measures. The overall number of participants analyzed for this measure is n=23 because the three participants who did not initiate MBSR+PS were not invited to complete this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Duration of Home Practices From Baseline to 12 Weeks | 36.21 number of minutes per day | Standard Deviation 35 |
Secondary
Frequency of Home Practices From Baseline to 12 Weeks
Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants randomized to TAU will not complete this measure.
Time frame: Baseline to post-intervention, an average of 12 weeks
Population: Participants randomized to MBSR+PS. The participant flow module lists n=24 analyzed because 24 participants completed endpoint measures. The overall number of participants analyzed for this measure is n=23 because the three participants who did not initiate MBSR+PS were not invited to complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Frequency of Home Practices From Baseline to 12 Weeks | MBSR Home Practice | 85.84 percentage of days | Standard Deviation 17.99 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Frequency of Home Practices From Baseline to 12 Weeks | PS Home Practice | 96.66 percentage of days | Standard Deviation 4.19 |
Secondary
Number of Participants Completing Endpoint Measures at 12 Weeks
For a measure to be considered complete, at least 95% of items must be completed.
Time frame: Post-intervention, an average of 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Number of Participants Completing Endpoint Measures at 12 Weeks | 24 Participants |
| Treatment as Usual | Number of Participants Completing Endpoint Measures at 12 Weeks | 24 Participants |
Secondary
Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks
Participants can attend 0-8 sessions of MBSR and of PS.
Time frame: Baseline to post-intervention, an average of 12 weeks
Population: This measure will only be collected for the MBSR+PS group; it is not applicable for participants randomized to TAU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks | 23 Participants |
Secondary
Percentage of MBSR and PS Sessions Attended
This measure will not be collected for participants randomized to TAU.
Time frame: Baseline to post-intervention, an average of 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Percentage of MBSR and PS Sessions Attended | MBSR attendance | 80.00 percentage of sessions attended | Standard Deviation 8.08 |
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Percentage of MBSR and PS Sessions Attended | PS attendance | 82.00 percentage of sessions attended | Standard Deviation 7.1 |
Secondary
Worry About Sleep Duration
Single item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks.
Time frame: Post-intervention, an average of 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS) | Worry About Sleep Duration | 9 Participants |
| Treatment as Usual | Worry About Sleep Duration | 8 Participants |