Mental DisordersMSRPNCT02292056
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
A study testing 1-on-1 counseling in people with Mental Disorders and Contraception, run by University of California, San Diego at 1 site in United States.
Trial summary
There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Mental Disorders, Contraception, Chemical Teratogen Exposure
- What is being tested?
- 1-on-1 counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2015
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Presenting for follow up psychiatric visit
- Ethnic Background: will include only english speaking participants (MotherToBaby counselors are only able to speak English)
- Level of Education: No limitation
- Health Status: at least one psychiatric condition for which they are taking medication
- Sexually active with Men
Who cannot join
- Planning to become pregnant
- Not sexually active with men
- History of hysterectomy, bilateral oophorectomy, or surgical sterilization
- Decisionally impaired - using post-consent instrument to assess decisional capacity. If a potential participant does not score 100% on post-consent instrument, then she will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gifford Clinic at UCSD Outpatient Psychiatry
San Diego, California, 92103
Sheila Mody, MD MPH, 619-543-6777, smody@ucsd.edu
About this study
There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at UCSD that will help women in this population better understand: 1) which of their medications are safe to use in pregnancy, 2) provide education regarding the importance of using contraception and which contraceptive choices are available to them, and 3) raise awareness of any drug-drug interactions that may exist between their medications and their chosen method of contraception. Patients will be given questionnaire to assess their contraceptive utilization. They will also be given a before and after quiz to allow for an objective measure of the patient's increase in knowledge regarding medication safety and contraceptive choices as a result of the investigators intervention.
Read the detailed description
Nearly half of all pregnancies in the general population in 2006-2010 were unintended. In addition, data from the National Survey of Family Growth shows that in 2006-2010, only 62.2% of women aged 15-44 in the United States are using some form of contraception. These statistics inherently suggest a need for additional education in the general population regarding contraceptive options. It is unknown how these statistics for the general population apply to women with psychiatric conditions. In addition, reproductive age women with psychiatric diagnoses have several unique family planning considerations, some of which are outlined below:
TERATOGENICITY OF PSYCHIATRIC MEDICATIONS:
Some women with psychiatric conditions may be on medications that are not safe for use in pregnancy and therefore may require counseling on their highly effective contraceptive options. These women may also have other environmental exposures to alcohol, tobacco and illicit drugs, so this may be an additional need for counseling about risk to a potential pregnancy. Other women in this population may become pregnant and stop using their psychiatric medications because they are unaware that their medications are safe to use in pregnancy. The United States Food and Drug Administration uses the following categories to rate the safety of using various pharmaceutical agents in pregnancy: A, controlled studies in humans fail to demonstrate a risk to the fetus in pregnancy; B, no evidence of risk to fetus in animal studies but no controlled studies for use in pregnant women; C, animal studies demonstrate an adverse effect on the fetus, but no controlled studies in humans; D, positive evidence of risk to fetus in human studies; and X, agent contraindicated in pregnancy because risks to fetus clearly outweigh potential benefits. Most psychotropic drugs used to treat bipolar disorder are category C or D. For example, lithium, a commonly prescribed mood stabilizer used as a first-line treatment for bipolar disorder, is associated with an increased risk of congenital cardiac abnormalities and is FDA category D for use in pregnancy. Also, valproate and carbamazapine, which are commonly used as mood stabilizers, have been associated with neural tube defects in the fetus and thus are also FDA category D for use in pregnancy.
CONTRACEPTION:
Women in this population may also wish to delay or avoid pregnancy due to the current state of their psychiatric condition and thus should be encouraged to use effective contraception. It has been shown that women with psychiatric diagnoses may interrupt their use of contraception due a variety of factors including: drug-drug interactions with their psychiatric medication, psychiatric hospitalization, loss of personal control over their medication administration, and preconceived notions of how contraception may impact their psychiatric condition or vice versa. Long-acting reversible contraceptive options, such as intrauterine devices (IUDs), requiring no patient compliance to achieve maximal efficacy may therefore be particularly well-suited options for these women. For these reasons, there may be a role for focused counseling in this population regarding options for safe, effective and reversible forms of contraception.
DRUG-DRUG INTERACTIONS:
Some women with psychiatric conditions are on medications that interact with combined hormonal contraceptives and may benefit from specialized counseling regarding which contraceptive options are safe for them to use. In 2010, the Centers for Disease Control and Prevention (CDC) published the United States Medical Eligibility Criteria (USMEC) in an effort to improve contraceptive safety guidance. The USMEC includes guidance on contraceptive safety for specific medications, including those commonly used to treat psychiatric illness. For example, carbamazapine, oxcarbazapine, lamictal, and topiramate, which are commonly prescribed for mood stabilization, increase the clearance rate of oral contraceptives; thus patients receiving one of these treatments should consider switching to an alternative form of contraception. The USMEC continues to be updated and will likely prove to be a valuable resource to optimize contraceptive counseling for these women.
This multidisciplinary research project involves a unique collaboration between the MotherToBaby Project, Reproductive Medicine at UCSD and Psychiatry at UCSD to deliver individualized contraceptive and teratogen counseling to women with psychiatric conditions. MotherToBaby California, formerly known as the CTIS Pregnancy Health Information Line, in the Department of Pediatrics at UCSD is a community-based organization founded 27 years ago which has been continuously funded at UCSD to provide direct-to-consumer and direct-to-health care provider counseling free of charge on the risks or safety of medications, chemicals, recreational drugs and alcohol, infectious or chronic disease, and medical conditions in pregnancy. The goal of MotherToBaby is to provide individualized risk assessments and referrals for further assistance or diagnostic testing to pregnant or breastfeeding women in order to prevent birth defects that are related to prenatal or breastfeeding exposures.
The proposed study will serve to investigate the feasibility of a novel type of counseling service that may uncover and address unmet family planning needs of reproductive age women with psychiatric diagnoses. The proposed project also promotes the utilization of the relatively new evidence-based USMEC contraceptive guidance from the CDC which has been endorsed by the American Congress of Obstetricians \& Gynecologists and American Academy of Family Physicians.
- Conditions
- Mental Disorders, Contraception, Chemical Teratogen Exposure
- Being tested
- 1-on-1 counseling
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-on-1 counselingBehavioural
- Precounseling questionnaire collecting demographic information, contraception information, and reasons for choosing contraceptive method
- Precounseling quiz: assess baseline level of knowledge regarding medication safety and contraceptive option.
- Counseling: completed by MotherToBaby counselor about the safety of their medications for use in pregnancy.
- 10 minute video entitled "The Contraceptive Choice Project: Which Birth Control Method is Right for You?" by Washington University in St. Louis.
- Post-Counseling Quiz to assess whether specialized training impacted their understanding of medication safety and contraceptive options.
- Post-Counseling Questionnaire: assess contraceptive plans and satisfaction with counseling
| Study group | Role | What they receive |
|---|---|---|
| Counseling Group | Experimental | Participation in the study will be completed in a single session and will involve a pre-counseling questionnaire, followed by a pre-counseling quiz, individualized counseling session, post-counseling quiz and post-counseling questionnaire. Receives: Behavioral: 1-on-1 counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Patient Knowledge
Assessed with score delta between Pre-counseling and Post-counseling Quizzes
Measured: 1 year
Secondary outcomes (3)
Contraceptive Plans
Captured in Post-Counseling questionnaire
Measured: 1 year
Utilization of Contraception
Captured in Pre-Counseling questionnaire
Measured: 1 year
Baseline Medication Safety Knowledge
Captured in Pre-Counseling questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- MotherToBaby
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Sheila Mody, MD MPH, Principal investigator, UCSD Department of Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292056
- Sponsor's protocol ID
- 131088
- Acronym
- MSRP
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Trussell J, Wynn LL. Reducing unintended pregnancy in the United States. Contraception. 2008 Jan;77(1):1-5. doi: 10.1016/j.contraception.2007.09.001. Epub 2007 Dec 3. No abstract available.
PubMed 18082659Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat 23. 2005 Dec;(25):1-160.
PubMed 16532609Curtis V. Women are not the same as men: specific clinical issues for female patients with bipolar disorder. Bipolar Disord. 2005;7 Suppl 1:16-24. doi: 10.1111/j.1399-5618.2005.00190.x.
PubMed 15762865Guedes TG, Moura ER, Almeida PC. Particularities of family planning in women with mental disorders. Rev Lat Am Enfermagem. 2009 Sep-Oct;17(5):639-44. doi: 10.1590/s0104-11692009000500007.
PubMed 19967211CDC. U.S. medical eligibility criteria for contraceptive use, 2010: adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th edition. MMWR 2010;59 (No. RR-4)
Crawford P. Interactions between antiepileptic drugs and hormonal contraception. CNS Drugs. 2002;16(4):263-72. doi: 10.2165/00023210-200216040-00005.
PubMed 11945109Committee opinion no. 505: understanding and using the U.S. Medical Eligibility Criteria For Contraceptive Use, 2010. Obstet Gynecol. 2011 Sep;118(3):754-760. doi: 10.1097/AOG.0b013e3182310cd3.
PubMed 21860318
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
- ClinicalTrials.gov ID
- NCT02292056
- Acronym / sponsor ID
- MSRP / 131088
- Conditions
- Mental Disorders, Contraception, Chemical Teratogen Exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- MotherToBaby
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 17 Nov 2014 (estimated)
- 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.
There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at UCSD that will help women in this population better understand: 1) which of their medications are safe to use in pregnancy, 2) provide education regarding the importance of using contraception and which contraceptive choices are available to them, and 3) raise awareness of any drug-drug interactions that may exist between their medications and their chosen method of contraception. Patients will be given questionnaire to assess their contraceptive utilization. They will also be given a before and after quiz to allow for an objective measure of the patient's increase in knowledge regarding medication safety and contraceptive choices as a result of the investigators intervention.
Detailed description
Nearly half of all pregnancies in the general population in 2006-2010 were unintended. In addition, data from the National Survey of Family Growth shows that in 2006-2010, only 62.2% of women aged 15-44 in the United States are using some form of contraception. These statistics inherently suggest a need for additional education in the general population regarding contraceptive options. It is unknown how these statistics for the general population apply to women with psychiatric conditions. In addition, reproductive age women with psychiatric diagnoses have several unique family planning considerations, some of which are outlined below:
TERATOGENICITY OF PSYCHIATRIC MEDICATIONS:
Some women with psychiatric conditions may be on medications that are not safe for use in pregnancy and therefore may require counseling on their highly effective contraceptive options. These women may also have other environmental exposures to alcohol, tobacco and illicit drugs, so this may be an additional need for counseling about risk to a potential pregnancy. Other women in this population may become pregnant and stop using their psychiatric medications because they are unaware that their medications are safe to use in pregnancy. The United States Food and Drug Administration uses the following categories to rate the safety of using various pharmaceutical agents in pregnancy: A, controlled studies in humans fail to demonstrate a risk to the fetus in pregnancy; B, no evidence of risk to fetus in animal studies but no controlled studies for use in pregnant women; C, animal studies demonstrate an adverse effect on the fetus, but no controlled studies in humans; D, positive evidence of risk to fetus in human studies; and X, agent contraindicated in pregnancy because risks to fetus clearly outweigh potential benefits. Most psychotropic drugs used to treat bipolar disorder are category C or D. For example, lithium, a commonly prescribed mood stabilizer used as a first-line treatment for bipolar disorder, is associated with an increased risk of congenital cardiac abnormalities and is FDA category D for use in pregnancy. Also, valproate and carbamazapine, which are commonly used as mood stabilizers, have been associated with neural tube defects in the fetus and thus are also FDA category D for use in pregnancy.
CONTRACEPTION:
Women in this population may also wish to delay or avoid pregnancy due to the current state of their psychiatric condition and thus should be encouraged to use effective contraception. It has been shown that women with psychiatric diagnoses may interrupt their use of contraception due a variety of factors including: drug-drug interactions with their psychiatric medication, psychiatric hospitalization, loss of personal control over their medication administration, and preconceived notions of how contraception may impact their psychiatric condition or vice versa. Long-acting reversible contraceptive options, such as intrauterine devices (IUDs), requiring no patient compliance to achieve maximal efficacy may therefore be particularly well-suited options for these women. For these reasons, there may be a role for focused counseling in this population regarding options for safe, effective and reversible forms of contraception.
DRUG-DRUG INTERACTIONS:
Some women with psychiatric conditions are on medications that interact with combined hormonal contraceptives and may benefit from specialized counseling regarding which contraceptive options are safe for them to use. In 2010, the Centers for Disease Control and Prevention (CDC) published the United States Medical Eligibility Criteria (USMEC) in an effort to improve contraceptive safety guidance. The USMEC includes guidance on contraceptive safety for specific medications, including those commonly used to treat psychiatric illness. For example, carbamazapine, oxcarbazapine, lamictal, and topiramate, which are commonly prescribed for mood stabilization, increase the clearance rate of oral contraceptives; thus patients receiving one of these treatments should consider switching to an alternative form of contraception. The USMEC continues to be updated and will likely prove to be a valuable resource to optimize contraceptive counseling for these women.
This multidisciplinary research project involves a unique collaboration between the MotherToBaby Project, Reproductive Medicine at UCSD and Psychiatry at UCSD to deliver individualized contraceptive and teratogen counseling to women with psychiatric conditions. MotherToBaby California, formerly known as the CTIS Pregnancy Health Information Line, in the Department of Pediatrics at UCSD is a community-based organization founded 27 years ago which has been continuously funded at UCSD to provide direct-to-consumer and direct-to-health care provider counseling free of charge on the risks or safety of medications, chemicals, recreational drugs and alcohol, infectious or chronic disease, and medical conditions in pregnancy. The goal of MotherToBaby is to provide individualized risk assessments and referrals for further assistance or diagnostic testing to pregnant or breastfeeding women in order to prevent birth defects that are related to prenatal or breastfeeding exposures.
The proposed study will serve to investigate the feasibility of a novel type of counseling service that may uncover and address unmet family planning needs of reproductive age women with psychiatric diagnoses. The proposed project also promotes the utilization of the relatively new evidence-based USMEC contraceptive guidance from the CDC which has been endorsed by the American Congress of Obstetricians \& Gynecologists and American Academy of Family Physicians.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Counseling Group | Experimental | Behavioral: 1-on-1 counselingParticipation in the study will be completed in a single session and will involve a pre-counseling questionnaire, followed by a pre-counseling quiz, individualized counseling session, post-counseling quiz and post-counseling questionnaire. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presenting for follow up psychiatric visit
- Ethnic Background: will include only english speaking participants (MotherToBaby counselors are only able to speak English)
- Level of Education: No limitation
- Health Status: at least one psychiatric condition for which they are taking medication
- Sexually active with Men
Key exclusion criteria (4 listed)
- Planning to become pregnant
- Not sexually active with men
- History of hysterectomy, bilateral oophorectomy, or surgical sterilization
- Decisionally impaired - using post-consent instrument to assess decisional capacity. If a potential participant does not score 100% on post-consent instrument, then she will be excluded from participation.
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 |
|---|---|---|
| 1-on-1 counseling1. Precounseling questionnaire collecting demographic information, contraception information, and reasons for choosing contraceptive method 2. Precounseling quiz: assess baseline level of knowledge regarding medication safety and contraceptive option. 3. Counseling: completed by MotherToBaby counselor about the safety of their medications for use in pregnancy. 4. 10 minute video entitled "The Contraceptive Choice Project: Which Birth Control Method is Right for You?" by Washington University in St. Louis. 5. Post-Counseling Quiz to assess whether specialized training impacted their understanding of medication safety and contraceptive options. 6. Post-Counseling Questionnaire: assess contraceptive plans and satisfaction with counseling | Behavioural | Counseling Group |
Primary outcome
Increase in Patient Knowledge
Time frame: 1 year
Assessed with score delta between Pre-counseling and Post-counseling Quizzes
3 secondary outcomes
Contraceptive Plans
Time frame: 1 year
Utilization of Contraception
Time frame: 1 year
Baseline Medication Safety Knowledge
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Background: PubMed 18082659Trussell J, Wynn LL. Reducing unintended pregnancy in the United States. Contraception. 2008 Jan;77(1):1-5. doi: 10.1016/j.contraception.2007.09.001. Epub 2007 Dec 3. No abstract available.
- Background: PubMed 16532609Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning, and reproductive health of U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat 23. 2005 Dec;(25):1-160.
- Background: PubMed 15762865Curtis V. Women are not the same as men: specific clinical issues for female patients with bipolar disorder. Bipolar Disord. 2005;7 Suppl 1:16-24. doi: 10.1111/j.1399-5618.2005.00190.x.
- Background: PubMed 19967211Guedes TG, Moura ER, Almeida PC. Particularities of family planning in women with mental disorders. Rev Lat Am Enfermagem. 2009 Sep-Oct;17(5):639-44. doi: 10.1590/s0104-11692009000500007.
- BackgroundCDC. U.S. medical eligibility criteria for contraceptive use, 2010: adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th edition. MMWR 2010;59 (No. RR-4)
- Background: PubMed 11945109Crawford P. Interactions between antiepileptic drugs and hormonal contraception. CNS Drugs. 2002;16(4):263-72. doi: 10.2165/00023210-200216040-00005.
- Background: PubMed 21860318Committee opinion no. 505: understanding and using the U.S. Medical Eligibility Criteria For Contraceptive Use, 2010. Obstet Gynecol. 2011 Sep;118(3):754-760. doi: 10.1097/AOG.0b013e3182310cd3.
- "The Contraceptive Choice Project: Which Birth Control Method is Right for You?" by Washington University in St. LouisLink provided by the sponsor.
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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.
Sheila Mody, MD MPH principal investigator
UCSD Department of Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-on-1 counseling in people with Mental Disorders and Contraception, run by University of California, San Diego 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: status not confirmed, as of the sponsor's last update on 17 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila Mody, MD MPH (619-543-6777, smody@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Patient Knowledge (time frame: 1 year). 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 NCT02292056, which also lists 7 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 17 Nov 2014.