SleepRISENCT05017974
Research on Improving Sleep During Pregnancy
A study testing Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement and Treatment as Usual in people with Sleep and Pregnancy Related, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sleep, Pregnancy Related
- What is being tested?
- Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 14 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence
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).
Read the 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:
- To determine acceptability of MBSR+PS.
- To determine feasibility of MBSR+PS.
- To determine adherence to MBSR+PS.
- To explore evidence of change in psychological mediators.
- To explore between-group differences in sleep.
- 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.
- Conditions
- Sleep, Pregnancy Related
- Being tested
- Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement, Treatment as Usual
- Keywords
- pregnancy, sleep, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction plus Prenatal Sleep supplementBehavioural
MBSR+PS
Treatment as UsualOther
TAU
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS) | Experimental | 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. Receives: Behavioral: Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement; Other: Treatment as Usual |
| Treatment as Usual | Other | 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention, an average of 12 weeks
Secondary outcomes (18)
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.
Measured: Baseline to post-intervention, an average of 12 weeks
Number of Participants Completing Endpoint Measures at 12 Weeks
For a measure to be considered complete, at least 95% of items must be completed.
Measured: Post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
Percentage of MBSR and PS Sessions Attended
This measure will not be collected for participants randomized to TAU.
Measured: Baseline to post-intervention, an average of 12 weeks
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.
Measured: Baseline to post-intervention, an average of 12 weeks
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.
Measured: Baseline to post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
Worry About Sleep Duration
Single item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks.
Measured: Post-intervention, an average of 12 weeks
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.
Measured: Baseline to post-intervention, an average of 12 weeks
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
Measured: Baseline and post-intervention, an average of 12 weeks
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.
Measured: Baseline and post-intervention, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start8 Sep 2021
- Primary completion29 Jun 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Jennifer N Felder, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017974
- Sponsor's protocol ID
- 20-32853
- Other IDs
- K23AT009896
- Acronym
- RISE
- Status last verified
- Nov 2023
- First submitted
- 17 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence
- ClinicalTrials.gov ID
- NCT05017974
- Acronym / sponsor ID
- RISE / 20-32853
- Conditions
- Sleep, Pregnancy Related
- Keywords
- pregnancy, sleep, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine acceptability of MBSR+PS.
- To determine feasibility of MBSR+PS.
- To determine adherence to MBSR+PS.
- To explore evidence of change in psychological mediators.
- To explore between-group differences in sleep.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS) | Experimental | Behavioral: Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement, Other: Treatment as UsualThe 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. |
| Treatment as Usual | Other | Other: Treatment as UsualThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction plus Prenatal Sleep supplementMBSR+PS | Behavioural | Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS) |
| Treatment as UsualTAU | Other | Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS), Treatment as Usual |
Primary outcome
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
Time frame: 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.
18 secondary outcomes
Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks
Time frame: Baseline to post-intervention, an average of 12 weeks
Number of Participants Completing Endpoint Measures at 12 Weeks
Time frame: Post-intervention, an average of 12 weeks
Completeness of Study Measures at Baseline and at 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Percentage of MBSR and PS Sessions Attended
Time frame: Baseline to post-intervention, an average of 12 weeks
Frequency of Home Practices From Baseline to 12 Weeks
Time frame: Baseline to post-intervention, an average of 12 weeks
Duration of Home Practices From Baseline to 12 Weeks
Time frame: Baseline to post-intervention, an average of 12 weeks
Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Worry About Sleep Duration
Time frame: Post-intervention, an average of 12 weeks
Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks
Time frame: Baseline to post-intervention, an average of 12 weeks
Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks
Time frame: Baseline and post-intervention, an average of 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer N Felder, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement and Treatment as Usual in people with Sleep and Pregnancy Related, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Post-intervention, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.