Anxiety Disorders GeneralizedNCT05867680
Feasibility Trial of an Online Course (eMB) to Reduce Anxiety and Depression for Pregnant Women and Their Partners
A study testing Online Mothers and Babies Course (eMB) in people with Anxiety Disorders Generalized and Depression, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders Generalized, Depression
- What is being tested?
- Online Mothers and Babies Course (eMB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, cis-gender and heterosexual pregnant people
- Pregnancy between 13- and 30 weeks gestation
- Elevated symptoms of pregnancy anxiety or depression (i.e., above the cut-off of 10 with validated measures - the Patient Health Questionaire-9 (PHQ-9; 33) or the Generalized Anxiety Disorder-7 (GAD-7; 29)
- Enrolled as a couple with the pregnant person and their partner cohabitating in Missouri and having internet access
Who cannot join
- If either person in the couple did not meet the inclusion criteria
- Endorsed suicide risk,
- Could not comprehend the consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Trial of the Online Mothers and Babies Course (eMB): Improving Perinatal Mental Health for Pregnant Women and Their Partners
This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability.
The intervention group received the 8-week eMB and the control group received an informational resources sheet.
Read the detailed description
Perinatal anxiety and depression are common, often co-morbid, and occur more frequently than outside pregnancy. Preventative measures can reduce the risk of poor mental and physical health outcomes and improve coping self-efficacy and the perception of social support. The antenatal period is an optimal time for intervention. Efficacious interventions include engaging pregnant people in cognitive-behavioral therapy and increasing the pregnant person's perception of social support -particularly partner support. Despite the evidence that partners can buffer stressors and, more generally, that perceived social support is protective, there are few interventions to reduce symptoms of anxiety or depression that involve partners. Online interventions can effectively manage mental health, increase knowledge and access to resources, and improve social connectivity. Online interventions have decreased perinatal anxiety, depression, and perception of stress, increased awareness about mental health risk factors and protective strategies, and improved coping self-efficacy successfully. Although perceived partner support is protective against poor mental health for pregnant people, partners' potential roles in online interventions is an understudied area of intervention innovation. Expanding the number of effective and equitably accessible online interventions is essential, given structural and social barriers to care.
Engaging the pregnant person and her partner as a dyad in perinatal studies complicates recruitment, retention, adherence, and longitudinally measuring change. This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability.
Analytic Approach The approach follows Whitehead et al. (2016) guidance on sample size to complete a pilot feasibility trial; a sample size of 30 people for each condition was necessary. (1) The study uses univariate analysis to calculate descriptive statistics describing the sample and feasibility outcomes.
Given the study's aims, the study hypothesized that it would be feasible to deliver the program to pregnant couples and there would be a significant reduction in anxiety and depression symptoms in favor of the intervention group. A factorial Analysis of Variance (ANOVA) with repeated measures on the dyadic role and survey time was used to test the study hypotheses. The analysis used an intention-to-treat analysis approach and a significance level of α = 0.05 or less. Repeated measures were recorded three times for each participant and each outcome of interest to evaluate the effect of the eMB course. Based on the minimum Akaike Information Criterion (AIC), researchers used an optimal residual covariance structure for each outcome. When factor interactions were significant, posthoc comparisons were used. The study retained data when available and dropped cases missing at times two or three. Data missing in this study are considered missing at random and analyzed with maximum likelihood estimation. Analyses were conducted using SPSS software.
To assess the degree of program satisfaction, item responses were summed, and the average satisfaction score was calculated for the intervention group. Interview data were analyzed using an inductive thematic approach. Both authors are PhD-trained researchers with extensive qualitative experience and contributions to various health and social science studies. The analysis occurred in stages: preparing transcripts after Zoom download, becoming familiar with the data, creating memos, coding (i.e., applying labels to text segments), searching for patterns in the coding, defining and naming themes from patterns, and writing up results. Analysis was conducted in Dedoose. The study investigator completed each stage first, and a member check was conducted by the second researcher.
- Conditions
- Anxiety Disorders Generalized, Depression
- Being tested
- Online Mothers and Babies Course (eMB)
- Keywords
- prenatal, Online intervention, randomized control trial, feasibility, couples, Cognitive Behavioral Therapy
- Medical subject headings
- Generalized Anxiety Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mothers and Babies Course (eMB)Behavioural
The eMB is an online, asynchronous, self-administered intervention modeled after the efficacious and in-person Mothers and Babies Course. (4) The eight-week course includes psychoeducational modules containing YouTube videos, vignettes, interactive quizzes, homework, guided meditations, and downloadable resources that teach strategies to promote a healthy outcome for mothers and their newborns: 1) overview, 2) thoughts and my mood, 3) fighting harmful and increasing helpful thoughts, 4) activities and my mood, 5) pleasant activities help make a healthy reality, 6) contact with others and my mood, 7) planning for the future and graduation, 8) relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment group participants received the eMB intervention during the 8-week trial period. Receives: Behavioral: Online Mothers and Babies Course (eMB) |
| Control | No intervention | The control group received a PDF community resources informational sheet, also available to the intervention group via the eMB program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 has seven self-reported items assessing general anxiety levels and has good reliability (α =.89). The responses are scored zero to three based on symptom severity, and the sum of all items ranges from zero to 21. A score of five, 10, and 15 are cut points for mild, moderate, and severe anxiety. (Spitzer et al.2006)
Measured: Change between baseline, week 4 and 8
Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a ten-item self-reported questionnaire validated for use in pregnancy, acceptable for use with partners, and found to have good reliability (α = .87). The item responses are scored from zero to three to indicate symptom severity, and three questions are reverse-scored. A total score ranges from zero to 30. A score of ten or more indicates moderate symptom severity and is considered the optimal cut-off for further assessment or intervention.(Murry and Cox, 1990)
Measured: Change between baseline, week 4 and 8
Implementation feasibility
For feasibility measures, we used study tracking data and Qualtrics usage analytics; these include recruitment, retention and attrition rates, and participant intervention adherence. The recruitment rate is the proportion of study inquiries and enrollments. Retention is the portion of survey completions and the reminders at each measurement time for each person. Attrition is the proportion of enrolled dyads and dropouts (i.e., both members failed to complete the final two surveys).
Measured: Upon trial completion
Intervention adherence
Intervention adherence is the average number of participants completing one lesson per week, the proportion of fully or partially complete lessons, and the average total lessons visited. An additional descriptive usage measure was captured with a multiple-option survey item asking whether the participant used eMB alone, together with their counterparts, a combination of alone and together, or not at all.
Measured: Upon trial completion
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is a 4-point Likert scale with responses ranging from strongly disagree to agree strongly and is sum-scored from eight to 32. A score from eight to 13 is interpreted as "poor," 14-19 as "fair," 20-25 as "good," and 26-32 as "excellent" satisfaction. The scale has high internal consistency (α = .9) and is used routinely in healthcare research (Attkisson \& Greenfield, 1995). Satisfaction and program acceptability are also measured qualitatively using semi-structured interviews. Questions included prompts about the helpfulness of materials, ease of use, areas for improvement, and how the course improved coping behaviors.(Attkisson \& Zwick, 1982)
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jun 2020
- Primary completion8 Jan 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorders GeneralizedStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to the control or treatment group using a 1:1 parallel assignment.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Fahs Beck Fund for Research and Experimentation
- Responsible party
- Principal investigator, Shannon Canfield, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867680
- Sponsor's protocol ID
- 000686919
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171R. F. Muñoz, H.-N. Le, C. G. Ippen, M. A. Diaz, G. G. Urizar Jr, J. Soto, et al. Cognitive and Behavioral Practice 2007 Vol. 14 Issue 1 Pages 70-83
Moran TE, O'Hara MW. A partner-rating scale of postpartum depression: the Edinburgh Postnatal Depression Scale - Partner (EPDS-P). Arch Womens Ment Health. 2006 Jul;9(4):173-80. doi: 10.1007/s00737-006-0136-x. Epub 2006 Jun 8.
PubMed 16755331Murray D, Cox JL. Screening for depression during pregnancy with the Edinburgh Depression Scale (EDDS). J Reprod Infant Psyc. 1990;8(2):99-107.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963Canfield SM, Canada KE, Rolbiecki AJ, Petroski GF. Feasibility and acceptability of an online mental health intervention for pregnant women and their partners: a mixed method study with a pilot randomized control trial. BMC Pregnancy Childbirth. 2023 Oct 18;23(1):739. doi: 10.1186/s12884-023-06031-4.
PubMed 37853333
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial of the Online Mothers and Babies Course (eMB): Improving Perinatal Mental Health for Pregnant Women and Their Partners
- ClinicalTrials.gov ID
- NCT05867680
- Acronym / sponsor ID
- 000686919
- Conditions
- Anxiety Disorders Generalized, Depression
- Keywords
- prenatal, Online intervention, randomized control trial, feasibility, couples, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Fahs Beck Fund for Research and Experimentation
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability.
The intervention group received the 8-week eMB and the control group received an informational resources sheet.
Detailed description
Perinatal anxiety and depression are common, often co-morbid, and occur more frequently than outside pregnancy. Preventative measures can reduce the risk of poor mental and physical health outcomes and improve coping self-efficacy and the perception of social support. The antenatal period is an optimal time for intervention. Efficacious interventions include engaging pregnant people in cognitive-behavioral therapy and increasing the pregnant person's perception of social support -particularly partner support. Despite the evidence that partners can buffer stressors and, more generally, that perceived social support is protective, there are few interventions to reduce symptoms of anxiety or depression that involve partners. Online interventions can effectively manage mental health, increase knowledge and access to resources, and improve social connectivity. Online interventions have decreased perinatal anxiety, depression, and perception of stress, increased awareness about mental health risk factors and protective strategies, and improved coping self-efficacy successfully. Although perceived partner support is protective against poor mental health for pregnant people, partners' potential roles in online interventions is an understudied area of intervention innovation. Expanding the number of effective and equitably accessible online interventions is essential, given structural and social barriers to care.
Engaging the pregnant person and her partner as a dyad in perinatal studies complicates recruitment, retention, adherence, and longitudinally measuring change. This pilot study engaged pregnant couples experiencing elevated symptoms of maternal anxiety or depression with an existing online psychoeducation intervention, the Online Mothers and Babies Course (eMB). The study had three primary aims to assess overall feasibility; 1) explore the feasibility of delivering eMB to couples by assessing recruitment, retainment, and adherence, 2) examine eMB's preliminary efficacy for reducing PMAD symptoms, and 3) describe participants' satisfaction and perceptions about eMB acceptability.
Analytic Approach The approach follows Whitehead et al. (2016) guidance on sample size to complete a pilot feasibility trial; a sample size of 30 people for each condition was necessary. (1) The study uses univariate analysis to calculate descriptive statistics describing the sample and feasibility outcomes.
Given the study's aims, the study hypothesized that it would be feasible to deliver the program to pregnant couples and there would be a significant reduction in anxiety and depression symptoms in favor of the intervention group. A factorial Analysis of Variance (ANOVA) with repeated measures on the dyadic role and survey time was used to test the study hypotheses. The analysis used an intention-to-treat analysis approach and a significance level of α = 0.05 or less. Repeated measures were recorded three times for each participant and each outcome of interest to evaluate the effect of the eMB course. Based on the minimum Akaike Information Criterion (AIC), researchers used an optimal residual covariance structure for each outcome. When factor interactions were significant, posthoc comparisons were used. The study retained data when available and dropped cases missing at times two or three. Data missing in this study are considered missing at random and analyzed with maximum likelihood estimation. Analyses were conducted using SPSS software.
To assess the degree of program satisfaction, item responses were summed, and the average satisfaction score was calculated for the intervention group. Interview data were analyzed using an inductive thematic approach. Both authors are PhD-trained researchers with extensive qualitative experience and contributions to various health and social science studies. The analysis occurred in stages: preparing transcripts after Zoom download, becoming familiar with the data, creating memos, coding (i.e., applying labels to text segments), searching for patterns in the coding, defining and naming themes from patterns, and writing up results. Analysis was conducted in Dedoose. The study investigator completed each stage first, and a member check was conducted by the second researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random assignment to the control or treatment group using a 1:1 parallel assignment.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Online Mothers and Babies Course (eMB)Treatment group participants received the eMB intervention during the 8-week trial period. |
| Control | No intervention | –The control group received a PDF community resources informational sheet, also available to the intervention group via the eMB program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, cis-gender and heterosexual pregnant people
- Pregnancy between 13- and 30 weeks gestation
- Elevated symptoms of pregnancy anxiety or depression (i.e., above the cut-off of 10 with validated measures - the Patient Health Questionaire-9 (PHQ-9; 33) or the Generalized Anxiety Disorder-7 (GAD-7; 29)
- Enrolled as a couple with the pregnant person and their partner cohabitating in Missouri and having internet access
Key exclusion criteria (3 listed)
- If either person in the couple did not meet the inclusion criteria
- Endorsed suicide risk,
- Could not comprehend the consent document
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 |
|---|---|---|
| Online Mothers and Babies Course (eMB)The eMB is an online, asynchronous, self-administered intervention modeled after the efficacious and in-person Mothers and Babies Course. (4) The eight-week course includes psychoeducational modules containing YouTube videos, vignettes, interactive quizzes, homework, guided meditations, and downloadable resources that teach strategies to promote a healthy outcome for mothers and their newborns: 1) overview, 2) thoughts and my mood, 3) fighting harmful and increasing helpful thoughts, 4) activities and my mood, 5) pleasant activities help make a healthy reality, 6) contact with others and my mood, 7) planning for the future and graduation, 8) relaxation exercises. | Behavioural | Treatment |
Primary outcome
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Change between baseline, week 4 and 8
The GAD-7 has seven self-reported items assessing general anxiety levels and has good reliability (α =.89). The responses are scored zero to three based on symptom severity, and the sum of all items ranges from zero to 21. A score of five, 10, and 15 are cut points for mild, moderate, and severe anxiety. (Spitzer et al.2006)
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Change between baseline, week 4 and 8
The EPDS is a ten-item self-reported questionnaire validated for use in pregnancy, acceptable for use with partners, and found to have good reliability (α = .87). The item responses are scored from zero to three to indicate symptom severity, and three questions are reverse-scored. A total score ranges from zero to 30. A score of ten or more indicates moderate symptom severity and is considered the optimal cut-off for further assessment or intervention.(Murry and Cox, 1990)
Implementation feasibility
Time frame: Upon trial completion
For feasibility measures, we used study tracking data and Qualtrics usage analytics; these include recruitment, retention and attrition rates, and participant intervention adherence. The recruitment rate is the proportion of study inquiries and enrollments. Retention is the portion of survey completions and the reminders at each measurement time for each person. Attrition is the proportion of enrolled dyads and dropouts (i.e., both members failed to complete the final two surveys).
Intervention adherence
Time frame: Upon trial completion
Intervention adherence is the average number of participants completing one lesson per week, the proportion of fully or partially complete lessons, and the average total lessons visited. An additional descriptive usage measure was captured with a multiple-option survey item asking whether the participant used eMB alone, together with their counterparts, a combination of alone and together, or not at all.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: week 8
The CSQ-8 is a 4-point Likert scale with responses ranging from strongly disagree to agree strongly and is sum-scored from eight to 32. A score from eight to 13 is interpreted as "poor," 14-19 as "fair," 20-25 as "good," and 26-32 as "excellent" satisfaction. The scale has high internal consistency (α = .9) and is used routinely in healthcare research (Attkisson \& Greenfield, 1995). Satisfaction and program acceptability are also measured qualitatively using semi-structured interviews. Questions included prompts about the helpfulness of materials, ease of use, areas for improvement, and how the course improved coping behaviors.(Attkisson \& Zwick, 1982)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- BackgroundR. F. Muñoz, H.-N. Le, C. G. Ippen, M. A. Diaz, G. G. Urizar Jr, J. Soto, et al. Cognitive and Behavioral Practice 2007 Vol. 14 Issue 1 Pages 70-83
- Background: PubMed 16755331Moran TE, O'Hara MW. A partner-rating scale of postpartum depression: the Edinburgh Postnatal Depression Scale - Partner (EPDS-P). Arch Womens Ment Health. 2006 Jul;9(4):173-80. doi: 10.1007/s00737-006-0136-x. Epub 2006 Jun 8.
- BackgroundMurray D, Cox JL. Screening for depression during pregnancy with the Edinburgh Depression Scale (EDDS). J Reprod Infant Psyc. 1990;8(2):99-107.
- Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Derived from this study: PubMed 37853333Canfield SM, Canada KE, Rolbiecki AJ, Petroski GF. Feasibility and acceptability of an online mental health intervention for pregnant women and their partners: a mixed method study with a pilot randomized control trial. BMC Pregnancy Childbirth. 2023 Oct 18;23(1):739. doi: 10.1186/s12884-023-06031-4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mothers and Babies Course (eMB) in people with Anxiety Disorders Generalized and Depression, run by University of Missouri-Columbia 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 4 inclusion and 3 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 22 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Generalized Anxiety Disorder-7 (GAD-7) (time frame: Change between baseline, week 4 and 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867680, which also lists 8 linked publications.
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 22 May 2023.