Sleep Clinical Trial
— RISEOfficial title:
Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence
Verified date | November 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 52 |
Est. completion date | July 14, 2022 |
Est. primary completion date | June 29, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Post-intervention, an average of 12 weeks | |
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. | Baseline to post-intervention, an average of 12 weeks | |
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. | Post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
Secondary | Percentage of MBSR and PS Sessions Attended | This measure will not be collected for participants randomized to TAU. | Baseline to post-intervention, an average of 12 weeks | |
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. | Baseline to post-intervention, an average of 12 weeks | |
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. | Baseline to post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks | |
Secondary | Worry About Sleep Duration | Single item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks. | Post-intervention, an average of 12 weeks | |
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. | Baseline to post-intervention, an average of 12 weeks | |
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 |
Baseline and post-intervention, an average of 12 weeks | |
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. | Baseline and post-intervention, an average of 12 weeks |
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