Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03103217
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2016-03-21
Brief Title:
Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pregnancy is a time of significant adjustment and uncertainty Anxiety is common among this group and is associated with poor cognitive and physical outcomes for both the mother and child Few trials have been conducted to ascertain the effectiveness of brief psychological interventions designed to alleviate general anxiety labour and pregnancy specific anxiety and promote well being
The aim of this project is to establish if a brief Cognitive Behavioural Therapy treatment is effective in reducing general anxiety during pregnancy The study will also explore whether the treatment has an impact on reducing pregnancy specific and labour related anxiety and reducing medical intervention
The aim of this project is to establish if a brief Cognitive Behavioural Therapy treatment is effective in reducing general anxiety during pregnancy The study will also explore whether the treatment has an impact on reducing pregnancy specific and labour related anxiety and reducing medical intervention
Detailed Description:
This study is a prospective matched cohort design with follow up The treatment group will consist of women who attend once to a one off 3 hour brief cognitive behavioural therapy treatment CBT session Outcome measures will be completed at 3 time points baseline 2 weeks post intervention and 2 weeks post partum follow up
A previously published dataset collected locally will be used as a control group This dataset includes 120 sets of data who have completed the Hospital Anxiety and Depression Scale HADS which will be the primary outcome measure for this study Furthermore the dataset includes data on several key variables including age current pregnancy information past pregnancy information family and partner support available medical supportinput income education living circumstances and future plan These will be matched at key variables which are predictors of anxiety during pregnancy and might otherwise be expected to influence scores on outcome variables and utilised as covariates The outcome measures will be completed at the same time points follow up 2 months post partum
As part of a preexisting maternity care system women are routinely offered a stress reduction session by their community midwives Those who wish to attend are routinely placed on a database For the purpose of this research everyone who has been put forward for the group will be sent a covering letter personal Information sheet PIS and screening HADS by the lead clinician Mo Tabib - midwife Participants who express an interest will be invited to have a telephone consultation with the chief Investigator During this telephone call eligibility will be discussed ad if appropriate telephone consent will be sought Following this those who do not meet eligibility criteria will be invited to attend the session as planned at Aberdeen Maternity Hospital and continue with their maternity care as usual Eligible participants will be sent a pack of baseline measures as well as a consent form Participants will have the option of returning these in a pre paid envelope or deposit in a confidential box at the session Consent will also be sought for access to online medical records and consent to contact participants following the group by phonetextemail as reminder Participants will be emailed two weeks following the session as a reminder to complete second set of measures Participants will identify three areas which they will commit to practice following the session The chief investigator will track their delivery date using using an online care system 2 months post-partum they will receive a further reminder text to complete final questionnaire set
The chief researcher will seek informed telephone consent initially which can be withdrawn at any time Consent will be discussed with potential participants during a telephone consultation following being sent the PIS and screening tool If potential participants are interested and eligible the chief researcher will send out a consent form by means of written consent where participants will be offered choice of returning in post or deposit in a confidential box at the session It will be highlighted that participants can withdraw from the study at any point
A previously published dataset collected locally will be used as a control group This dataset includes 120 sets of data who have completed the Hospital Anxiety and Depression Scale HADS which will be the primary outcome measure for this study Furthermore the dataset includes data on several key variables including age current pregnancy information past pregnancy information family and partner support available medical supportinput income education living circumstances and future plan These will be matched at key variables which are predictors of anxiety during pregnancy and might otherwise be expected to influence scores on outcome variables and utilised as covariates The outcome measures will be completed at the same time points follow up 2 months post partum
As part of a preexisting maternity care system women are routinely offered a stress reduction session by their community midwives Those who wish to attend are routinely placed on a database For the purpose of this research everyone who has been put forward for the group will be sent a covering letter personal Information sheet PIS and screening HADS by the lead clinician Mo Tabib - midwife Participants who express an interest will be invited to have a telephone consultation with the chief Investigator During this telephone call eligibility will be discussed ad if appropriate telephone consent will be sought Following this those who do not meet eligibility criteria will be invited to attend the session as planned at Aberdeen Maternity Hospital and continue with their maternity care as usual Eligible participants will be sent a pack of baseline measures as well as a consent form Participants will have the option of returning these in a pre paid envelope or deposit in a confidential box at the session Consent will also be sought for access to online medical records and consent to contact participants following the group by phonetextemail as reminder Participants will be emailed two weeks following the session as a reminder to complete second set of measures Participants will identify three areas which they will commit to practice following the session The chief investigator will track their delivery date using using an online care system 2 months post-partum they will receive a further reminder text to complete final questionnaire set
The chief researcher will seek informed telephone consent initially which can be withdrawn at any time Consent will be discussed with potential participants during a telephone consultation following being sent the PIS and screening tool If potential participants are interested and eligible the chief researcher will send out a consent form by means of written consent where participants will be offered choice of returning in post or deposit in a confidential box at the session It will be highlighted that participants can withdraw from the study at any point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None