AnxietyNCT03103217
Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women
A study testing brief CBT for anxious pregnant women in people with Anxiety, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- brief CBT for anxious pregnant women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 30 Apr 2017
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Pregnant woman
- Referred to group and screened for suitability
- Attended brief pregnancy session
- Contact with community midwife
- General anxiety (Score >8 on HADS)
- Able to read, write and understand English
- Aged over 16
- Ability to give consent
Who cannot join
- Exclusion criteria will include severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder; terminal illness; inability to give informed consent in English, and inability to understand written and spoken English as questionnaires are not standardized in other languages.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Anxiety
- Being tested
- brief CBT for anxious pregnant women
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief CBT for anxious pregnant womenBehavioural
one off 3 hour session including psychoeducation, exploration of cognitions and experiential practice of behavioural techniques.
| Study group | Role | What they receive |
|---|---|---|
| Brief CBT intervention | Experimental | Not described Receives: Behavioral: brief CBT for anxious pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to post intervention and at follow-up -Hospital depression and anxiety scale
Measured: baseline, 2 weeks and 2 months
Secondary outcomes (3)
Change from Baseline to post intervention - Pregnancy Related Anxiety Questionnaire - Short
Measured: baseline and 2 weeks
Change from Baseline to post intervention and at follow-up - The Warick Edinburgh Mental Well-being scale
Measured: baseline, 2 weeks and 2 months
Childbirth experience questionnaire
Measured: 2 months only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startJul 2016
- Primary completionJan 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Paul Morris, Health Psychology, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103217
- Sponsor's protocol ID
- AC 16012
- Status last verified
- May 2024
- First submitted
- 21 Mar 2016
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of a Brief CBT Intervention for Anxious Pregnant Women
- ClinicalTrials.gov ID
- NCT03103217
- Acronym / sponsor ID
- AC 16012
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 6 Apr 2017 (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.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief CBT intervention | Experimental | Behavioral: brief CBT for anxious pregnant women |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- - Pregnant woman
- Referred to group and screened for suitability
- Attended brief pregnancy session
- Contact with community midwife
- General anxiety (Score >8 on HADS)
Key exclusion criteria (1 listed)
- Exclusion criteria will include severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder; terminal illness; inability to give informed consent in English, and inability to understand written and spoken English as questionnaires are not standardized in other languages.
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 |
|---|---|---|
| brief CBT for anxious pregnant womenone off 3 hour session including psychoeducation, exploration of cognitions and experiential practice of behavioural techniques. | Behavioural | Brief CBT intervention |
Primary outcome
Change from Baseline to post intervention and at follow-up -Hospital depression and anxiety scale
Time frame: baseline, 2 weeks and 2 months
3 secondary outcomes
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
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 7 May 2024.
- 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.
Paul Morris, Health Psychology study chair
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief CBT for anxious pregnant women in people with Anxiety, run by University of Edinburgh at 1 site in United Kingdom.
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 8 inclusion and 1 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 7 May 2024. 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 Kingdom. 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?
Change from Baseline to post intervention and at follow-up -Hospital depression and anxiety scale (time frame: baseline, 2 weeks and 2 months). 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 7 May 2024.