Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03103217|
Recruitment Status : Unknown
Verified March 2017 by University of Edinburgh.
Recruitment status was: Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Behavioral: brief CBT for anxious pregnant women||Not Applicable|
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 support/input, 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 phone/text/email 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||April 2017|
|Experimental: Brief CBT intervention||
Behavioral: brief CBT for anxious pregnant women
one off 3 hour session including psychoeducation, exploration of cognitions and experiential practice of behavioural techniques.
- Change from Baseline to post intervention and at follow-up -Hospital depression and anxiety scale [ Time Frame: baseline, 2 weeks and 2 months ]
- Change from Baseline to post intervention - Pregnancy Related Anxiety Questionnaire - Short [ Time Frame: baseline and 2 weeks ]
- Change from Baseline to post intervention and at follow-up - The Warick Edinburgh Mental Well-being scale [ Time Frame: baseline, 2 weeks and 2 months ]
- Childbirth experience questionnaire [ Time Frame: 2 months only ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103217
|Aberdeen, Scotland, United Kingdom, AB24 5RN|
|Study Chair:||Paul Morris, Health Psychology||University of Edinburgh|