Trial Outcomes & Findings for Research on Improving Sleep During Pregnancy (NCT NCT05017974)
NCT ID: NCT05017974
Last Updated: 2023-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Post-intervention, an average of 12 weeks
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research on Improving Sleep During Pregnancy
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.31 years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
31.85 years
STANDARD_DEVIATION 5.45 • n=7 Participants
|
32.58 years
STANDARD_DEVIATION 5.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, White, or European American
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latina, Latin American, or Hispanic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bi- or multi-racial or -ethnic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
|
7.12 units on a scale
STANDARD_DEVIATION 2.57 • n=5 Participants
|
7.15 units on a scale
STANDARD_DEVIATION 1.74 • n=7 Participants
|
7.13 units on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-intervention, an average of 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=23 Participants
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
|
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
|
|---|---|---|
|
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 outcome
Timeframe: Baseline to post-intervention, an average of 12 weeksPopulation: This measure will only be collected for the MBSR+PS group; it is not applicable for participants randomized to TAU.
Participants can attend 0-8 sessions of MBSR and of PS.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
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
|
|---|---|---|
|
Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-intervention, an average of 12 weeksFor a measure to be considered complete, at least 95% of items must be completed.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Number of Participants Completing Endpoint Measures at 12 Weeks
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksFor 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Completeness of Study Measures at Baseline and at 12 Weeks
|
95.2 percentage of measures completed
|
96.1 percentage of measures completed
|
SECONDARY outcome
Timeframe: Baseline to post-intervention, an average of 12 weeksThis measure will not be collected for participants randomized to TAU.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
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
|
|---|---|---|
|
Percentage of MBSR and PS Sessions Attended
MBSR attendance
|
80.00 percentage of sessions attended
Standard Deviation 8.08
|
—
|
|
Percentage of MBSR and PS Sessions Attended
PS attendance
|
82.00 percentage of sessions attended
Standard Deviation 7.10
|
—
|
SECONDARY outcome
Timeframe: Baseline to post-intervention, an average of 12 weeksPopulation: 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.
Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants randomized to TAU will not complete this measure.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=23 Participants
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
|
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
|
|---|---|---|
|
Frequency of Home Practices From Baseline to 12 Weeks
MBSR Home Practice
|
85.84 percentage of days
Standard Deviation 17.99
|
—
|
|
Frequency of Home Practices From Baseline to 12 Weeks
PS Home Practice
|
96.66 percentage of days
Standard Deviation 4.19
|
—
|
SECONDARY outcome
Timeframe: Baseline to post-intervention, an average of 12 weeksPopulation: 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.
Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants assigned to TAU will not complete this measure.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=23 Participants
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
|
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
|
|---|---|---|
|
Duration of Home Practices From Baseline to 12 Weeks
|
36.21 number of minutes per day
Standard Deviation 35.00
|
—
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks
|
1.12 units on a scale
Standard Deviation 5.64
|
2.71 units on a scale
Standard Deviation 7.57
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksWe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
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
|
1.58 units on a scale
Standard Deviation 5.72
|
|
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
|
1.46 units on a scale
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Catastrophizing score
|
-.36 units on a scale
Standard Deviation .58
|
-.14 units on a scale
Standard Deviation 1.04
|
|
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Distracting score
|
.38 units on a scale
Standard Deviation .73
|
-.09 units on a scale
Standard Deviation .98
|
|
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Ignoring score
|
-.25 units on a scale
Standard Deviation 1.03
|
.03 units on a scale
Standard Deviation 1.21
|
|
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Distancing score
|
.54 units on a scale
Standard Deviation 1.34
|
.41 units on a scale
Standard Deviation .98
|
|
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Coping score
|
-.08 units on a scale
Standard Deviation .93
|
-.05 units on a scale
Standard Deviation .97
|
|
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Praying score
|
.04 units on a scale
Standard Deviation .95
|
.33 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks
Rumination score
|
-1.46 units on a scale
Standard Deviation 6.85
|
-2.75 units on a scale
Standard Deviation 5.84
|
|
Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks
Reflection score
|
.96 units on a scale
Standard Deviation 3.85
|
-.13 units on a scale
Standard Deviation 5.04
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks
|
-2.58 units on a scale
Standard Deviation 2.21
|
-1.79 units on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks
|
-5.29 units on a scale
Standard Deviation 4.09
|
-4.17 units on a scale
Standard Deviation 4.06
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks
|
-1.11 units on a scale
Standard Deviation 1.15
|
-.96 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksPopulation: Data were not collected for this measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-intervention, an average of 12 weeksSingle item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=24 Participants
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
|
Treatment as Usual
n=24 Participants
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
|
|---|---|---|
|
Worry About Sleep Duration
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks
|
-1.78 units on a scale
Standard Deviation 2.70
|
-1.38 units on a scale
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks
|
-1.45 T-score
Standard Deviation 7.79
|
-2.32 T-score
Standard Deviation 7.55
|
SECONDARY outcome
Timeframe: Baseline and post-intervention, an average of 12 weeksThe 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 Participants
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
|
Treatment as Usual
n=26 Participants
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
|
|---|---|---|
|
Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks
|
-1.83 units on a scale
Standard Deviation 3.93
|
-2.46 units on a scale
Standard Deviation 5.14
|
Adverse Events
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)
n=26 participants at risk
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
|
Treatment as Usual
n=26 participants at risk
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
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
gestational diabetes dx
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
7.7%
2/26 • Number of events 2 • Baseline to 12 weeks
|
|
Infections and infestations
COVID diagnosis
|
11.5%
3/26 • Number of events 3 • Baseline to 12 weeks
|
7.7%
2/26 • Number of events 2 • Baseline to 12 weeks
|
|
Psychiatric disorders
Elevated anxiety symptoms
|
7.7%
2/26 • Number of events 2 • Baseline to 12 weeks
|
0.00%
0/26 • Baseline to 12 weeks
|
|
Psychiatric disorders
Elevated depressive symptoms
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/26 • Baseline to 12 weeks
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
|
Cardiac disorders
High blood pressure
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
0.00%
0/26 • Baseline to 12 weeks
|
|
Psychiatric disorders
Passive suicidal ideation
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/26 • Baseline to 12 weeks
|
3.8%
1/26 • Number of events 1 • Baseline to 12 weeks
|
Additional Information
Dr. Jennifer Felder
University of California, San Francisco
Phone: 415-476-7014
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place