CALM for Pregnant and Post-Partum Women
| Status: | Suspended |
|---|---|
| Conditions: | Anxiety, Anxiety, Depression, Depression, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/13/2018 |
| Start Date: | January 1, 2019 |
| End Date: | June 30, 2021 |
A Randomized Controlled Trial of Coordinated Anxiety Learning and Management (CALM) for Pregnant and Postpartum Women
Anxiety and depression is common along pregnant mothers and has been found to increase risk
for negative outcomes in both mothers and infants. These risks can include low infant birth
weight, negative mother-infant interactions, and delayed developmental outcomes.
Evidenced-based interventions to support pregnant women experiencing symptoms of depression
or anxiety are not well studied or widely available, particularly for low-income women of
color. These women may not have access to the type of healthcare that would best support
their needs and/or they may not be familiar with or trust clinicians who deliver mental
health interventions. The current randomized-controlled trial (RCT) aims to address these
gaps in the literature by testing the feasibility and efficacy of a doula-supported,
computer-assisted delivery of a cognitive behavioral therapy (CBT) intervention designed to
reduce pregnancy-related anxiety, depression, and prevent perinatal mood disorders. The 120
participants in the study (60 Black women and 60 Hispanic/Latina women) will be randomized to
either receive the Coordinated Anxiety Learning and Management (CALM) intervention (n=60) or
treatment as usual (n=60). Participants assigned to the intervention will complete 6-8
sessions of CALM with a language and ethnically/racially-matched doula who has been trained
as a CALM specialist in order to increase participant comfort and reduce the stigma
associated with mental health services. Women in both groups will complete assessments of
their pregnancy-related anxiety, general anxiety, depressive symptoms, and satisfaction with
treatment (CALM or treatment as usual) at baseline, 12-weeks post-baseline, and 10-weeks
post-birth. It is hypothesized that women assigned to the CALM intervention will have
significantly less anxiety and depressive symptoms post-treatment and post-partum compared to
the women assigned to treatment as usual. The results of the current RCT will be used to test
the efficacy of the CALM intervention for pregnant women or color and to inform efforts for
potential future scalability.
for negative outcomes in both mothers and infants. These risks can include low infant birth
weight, negative mother-infant interactions, and delayed developmental outcomes.
Evidenced-based interventions to support pregnant women experiencing symptoms of depression
or anxiety are not well studied or widely available, particularly for low-income women of
color. These women may not have access to the type of healthcare that would best support
their needs and/or they may not be familiar with or trust clinicians who deliver mental
health interventions. The current randomized-controlled trial (RCT) aims to address these
gaps in the literature by testing the feasibility and efficacy of a doula-supported,
computer-assisted delivery of a cognitive behavioral therapy (CBT) intervention designed to
reduce pregnancy-related anxiety, depression, and prevent perinatal mood disorders. The 120
participants in the study (60 Black women and 60 Hispanic/Latina women) will be randomized to
either receive the Coordinated Anxiety Learning and Management (CALM) intervention (n=60) or
treatment as usual (n=60). Participants assigned to the intervention will complete 6-8
sessions of CALM with a language and ethnically/racially-matched doula who has been trained
as a CALM specialist in order to increase participant comfort and reduce the stigma
associated with mental health services. Women in both groups will complete assessments of
their pregnancy-related anxiety, general anxiety, depressive symptoms, and satisfaction with
treatment (CALM or treatment as usual) at baseline, 12-weeks post-baseline, and 10-weeks
post-birth. It is hypothesized that women assigned to the CALM intervention will have
significantly less anxiety and depressive symptoms post-treatment and post-partum compared to
the women assigned to treatment as usual. The results of the current RCT will be used to test
the efficacy of the CALM intervention for pregnant women or color and to inform efforts for
potential future scalability.
Setting and Sample Women will be recruited from six clinics in Alameda County that provide
prenatal care. In clinic settings, women will be approached by a trained and culturally
sensitive research graduate student researchers (GSRs) to determine their interest and
eligibility for CALM participation based on inclusion and exclusion criteria. A standard
screening form will be used.
Second, participants who remain eligible on the above criteria will be screened at the same
time for pregnancy anxiety, depressive and anxiety symptoms using standardized screening
instruments. Participants will be asked to complete the measures on a computer/tablet. Their
responses will be scored and they will be informed via a phone call if they are eligible for
the study. Those who score above population cutoffs for risk of disorders on The Overall
Anxiety Severity and Impairment Scale (OASIS), Edinburgh Perinatal Depression Scale (EPDS),
the Pregnancy-Specific Anxiety Scale (PSAS) and/or the Pregnancy-Related Anxiety Scale (PRAS)
are eligible for the study. Cutoffs are as follows:
1. Pregnancy Specific Anxiety 4 items Scale (cut off 15 or higher)
2. Pregnancy-Related Anxiety Scale (cut off 30 or higher)
b) OASIS (cut off of 8 or greater for positive screen for anxiety symptoms) c) EPDS if not
obtained as normal procedures in clinic at that time (cut off of 12 or greater for positive
screen for depression)
Third, a home visit (or visit in their location of preference) is then arranged for
participants who remain eligible for research staff to do the Mini International
Neuropsychiatric Interview in order to exclude any women with history of bipolar, psychosis,
current addiction or current suicidality. CALM web-based CBT is not recommended for
individuals with severe mental illness (e.g. bipolar disorder and psychosis) who need
additional services and will be given referrals. If not excluded on this basis research staff
will consent women into the RCT study, conduct a baseline assessment, and randomized to
treatment (CALM intervention) or control (Treatment as Usual) at the same home visit.
Randomization will be programmed within the RedCap system after participants completed their
baseline assessment. The computerized randomization schema will use blocked-randomization to
ensure that too many participants are not assigned to the CALM intervention at once.
Participants will be provided with remuneration at the end of the home visit, regardless of
whether they are found eligible and/or consent to participate in the study.
CALM Intervention (Treatment) Each CALM-trained doula (referred to in study as "CALM
specialist") will be assigned to a single participant for the entirety of their participation
in the RCT. Study participants randomized to CALM will be visited weekly or biweekly in their
home or location of preference by a CALM specialist between 6 and 8 times prenatally.
Sessions may extend into postpartum if needed as determined by the CALM specialist in
conjunction with their supervisor. Additional visits will vary based on continuing assessment
of symptoms.
The CALM program is interactive, with individualized data entered session by session (e.g.,
symptom scales, homework completion, fear hierarchies, response to exercises in session),
that is sometimes retrieved at later points throughout the program (e.g., fear hierarchies).
The interactive data entry provides a tool for objectively monitoring progress throughout the
program and a method for assessing symptom improvement from one visit to the next. In
addition, video vignettes are embedded throughout to demonstrate a therapist and patient
working together on a specific skill or component of treatment. To reinforce what was learned
in session, printouts of the session material (including patient's individualized information
that is entered) are given to participants at the completion of each session, providing them
with an individualized workbook that cumulates as they progress through the program.
Participants can also access the program through a patient portal to obtain more education,
guidance and forms. Also, each module ends with an assessment section in which patients rate
their understanding of the material and answer quiz questions, and clinicians rate the
patient's proficiency in implementing the specific cognitive behavioral skill. This
assessment information guides the participant and CALM specialist as to whether to repeat the
module or not.
During the intervention, the CALM specialist will sit side by side with the patient as they
both view the program on screen (see CALM Tools for Living Video, www.chammp.org). The
program provides a structure to guide the content of each visit, thereby enhancing the
integrity with which cognitive and behavioral strategies are presented and implemented in the
hands of novice clinicians. The CALM specialist guides the participants to read or talk about
material on the screen, following the general outline of module presentation described above.
Participants can read the information and then talk with the CALM specialist about what was
read, and/or or they can summarize the information that is presented on screen to the
participant, and then help them apply the information to their own situation.
In addition, the program prompts CALM specialists to engage in specific tasks repeatedly
throughout each module. These tasks include (1) stating the goals of each visit (2) entering
participant data (e.g., number of homework practices completed) (3) choosing which links to
select based on relevance to the participant's target problem (e.g., link for how to apply
cognitive restructuring to social anxiety versus depression) (4) instruction in and
demonstration of skills of breathing and cognitive restructuring (5) designing home work
practices between visits (5) reviewing and problem solving home work practices and (6)
summarizing the information from each section of the program. CALM Specialists will have
portable printers to leave a copy of the homework for the participants in the CALM group,
regardless of whether they have internet access to do it online.
The CALM specialist is trained in advance to use the program skillfully, so that they can
direct participants to which sections of the computerized treatment are most relevant to
them; inquire about and assess the patient's understanding of the material; summarize and
rephrase sections of the text as necessary to provide clarification; assist in the
application of CBT principles to the participants' idiosyncratic thoughts and behaviors; and
reinforce in-session skills practice and between-session assignment practice. Also, CALM
specialists may choose to skip some modules and advance to other modules based on the needs
of a given participant. CALM specialists will meet weekly by phone with a licensed clinical
psychologist (Co-I) for supervision and to ensure optimal care.
Study participants in the treatment group will also complete assessments at baseline, 12-week
post-baseline, and 10-week postpartum follow-ups.
Treatment as Usual (Control) Currently, participants who screen high on any of the anxiety or
depression measures are referred to behavioral and/or mental health services in Alameda
County using a public health department (ACPHD) generated list of providers. For the purposes
of this study, this procedure will remain the treatment as usual. Study participants not
randomized to CALM will receive treatment as usual (TAU) and will complete baseline, 12-week
post-baseline, and 10-week postpartum follow-up assessments only.
Measures Several measures in addition to the scores on the OASIS, EPDS, PSAS, and PRAS will
be used to describe the sample, examine treatment effects, and to evaluate the participant
satisfaction with the CALM program. First, a screening survey will be completed in the clinic
(OASIS, EPDS, PSAS, and PRAS). Next participant assessments will be administered at baseline,
12 weeks post-baseline, and 10 weeks postpartum for all participants. The baseline assessment
will be conducted in the home (or location of preference) as described above). The two
follow-up assessments will either be completed online or over the phone with a GSR, depending
on the participant's preference. Remuneration will be sent after completion of each
assessment.
prenatal care. In clinic settings, women will be approached by a trained and culturally
sensitive research graduate student researchers (GSRs) to determine their interest and
eligibility for CALM participation based on inclusion and exclusion criteria. A standard
screening form will be used.
Second, participants who remain eligible on the above criteria will be screened at the same
time for pregnancy anxiety, depressive and anxiety symptoms using standardized screening
instruments. Participants will be asked to complete the measures on a computer/tablet. Their
responses will be scored and they will be informed via a phone call if they are eligible for
the study. Those who score above population cutoffs for risk of disorders on The Overall
Anxiety Severity and Impairment Scale (OASIS), Edinburgh Perinatal Depression Scale (EPDS),
the Pregnancy-Specific Anxiety Scale (PSAS) and/or the Pregnancy-Related Anxiety Scale (PRAS)
are eligible for the study. Cutoffs are as follows:
1. Pregnancy Specific Anxiety 4 items Scale (cut off 15 or higher)
2. Pregnancy-Related Anxiety Scale (cut off 30 or higher)
b) OASIS (cut off of 8 or greater for positive screen for anxiety symptoms) c) EPDS if not
obtained as normal procedures in clinic at that time (cut off of 12 or greater for positive
screen for depression)
Third, a home visit (or visit in their location of preference) is then arranged for
participants who remain eligible for research staff to do the Mini International
Neuropsychiatric Interview in order to exclude any women with history of bipolar, psychosis,
current addiction or current suicidality. CALM web-based CBT is not recommended for
individuals with severe mental illness (e.g. bipolar disorder and psychosis) who need
additional services and will be given referrals. If not excluded on this basis research staff
will consent women into the RCT study, conduct a baseline assessment, and randomized to
treatment (CALM intervention) or control (Treatment as Usual) at the same home visit.
Randomization will be programmed within the RedCap system after participants completed their
baseline assessment. The computerized randomization schema will use blocked-randomization to
ensure that too many participants are not assigned to the CALM intervention at once.
Participants will be provided with remuneration at the end of the home visit, regardless of
whether they are found eligible and/or consent to participate in the study.
CALM Intervention (Treatment) Each CALM-trained doula (referred to in study as "CALM
specialist") will be assigned to a single participant for the entirety of their participation
in the RCT. Study participants randomized to CALM will be visited weekly or biweekly in their
home or location of preference by a CALM specialist between 6 and 8 times prenatally.
Sessions may extend into postpartum if needed as determined by the CALM specialist in
conjunction with their supervisor. Additional visits will vary based on continuing assessment
of symptoms.
The CALM program is interactive, with individualized data entered session by session (e.g.,
symptom scales, homework completion, fear hierarchies, response to exercises in session),
that is sometimes retrieved at later points throughout the program (e.g., fear hierarchies).
The interactive data entry provides a tool for objectively monitoring progress throughout the
program and a method for assessing symptom improvement from one visit to the next. In
addition, video vignettes are embedded throughout to demonstrate a therapist and patient
working together on a specific skill or component of treatment. To reinforce what was learned
in session, printouts of the session material (including patient's individualized information
that is entered) are given to participants at the completion of each session, providing them
with an individualized workbook that cumulates as they progress through the program.
Participants can also access the program through a patient portal to obtain more education,
guidance and forms. Also, each module ends with an assessment section in which patients rate
their understanding of the material and answer quiz questions, and clinicians rate the
patient's proficiency in implementing the specific cognitive behavioral skill. This
assessment information guides the participant and CALM specialist as to whether to repeat the
module or not.
During the intervention, the CALM specialist will sit side by side with the patient as they
both view the program on screen (see CALM Tools for Living Video, www.chammp.org). The
program provides a structure to guide the content of each visit, thereby enhancing the
integrity with which cognitive and behavioral strategies are presented and implemented in the
hands of novice clinicians. The CALM specialist guides the participants to read or talk about
material on the screen, following the general outline of module presentation described above.
Participants can read the information and then talk with the CALM specialist about what was
read, and/or or they can summarize the information that is presented on screen to the
participant, and then help them apply the information to their own situation.
In addition, the program prompts CALM specialists to engage in specific tasks repeatedly
throughout each module. These tasks include (1) stating the goals of each visit (2) entering
participant data (e.g., number of homework practices completed) (3) choosing which links to
select based on relevance to the participant's target problem (e.g., link for how to apply
cognitive restructuring to social anxiety versus depression) (4) instruction in and
demonstration of skills of breathing and cognitive restructuring (5) designing home work
practices between visits (5) reviewing and problem solving home work practices and (6)
summarizing the information from each section of the program. CALM Specialists will have
portable printers to leave a copy of the homework for the participants in the CALM group,
regardless of whether they have internet access to do it online.
The CALM specialist is trained in advance to use the program skillfully, so that they can
direct participants to which sections of the computerized treatment are most relevant to
them; inquire about and assess the patient's understanding of the material; summarize and
rephrase sections of the text as necessary to provide clarification; assist in the
application of CBT principles to the participants' idiosyncratic thoughts and behaviors; and
reinforce in-session skills practice and between-session assignment practice. Also, CALM
specialists may choose to skip some modules and advance to other modules based on the needs
of a given participant. CALM specialists will meet weekly by phone with a licensed clinical
psychologist (Co-I) for supervision and to ensure optimal care.
Study participants in the treatment group will also complete assessments at baseline, 12-week
post-baseline, and 10-week postpartum follow-ups.
Treatment as Usual (Control) Currently, participants who screen high on any of the anxiety or
depression measures are referred to behavioral and/or mental health services in Alameda
County using a public health department (ACPHD) generated list of providers. For the purposes
of this study, this procedure will remain the treatment as usual. Study participants not
randomized to CALM will receive treatment as usual (TAU) and will complete baseline, 12-week
post-baseline, and 10-week postpartum follow-up assessments only.
Measures Several measures in addition to the scores on the OASIS, EPDS, PSAS, and PRAS will
be used to describe the sample, examine treatment effects, and to evaluate the participant
satisfaction with the CALM program. First, a screening survey will be completed in the clinic
(OASIS, EPDS, PSAS, and PRAS). Next participant assessments will be administered at baseline,
12 weeks post-baseline, and 10 weeks postpartum for all participants. The baseline assessment
will be conducted in the home (or location of preference) as described above). The two
follow-up assessments will either be completed online or over the phone with a GSR, depending
on the participant's preference. Remuneration will be sent after completion of each
assessment.
Inclusion Criteria:
- English or Spanish speaking
- Black or Hispanic/Latina women
- Over the age of 18
- Live or work in Oakland, CA.
CALM eligibility is based on two levels of screening. First, participants who score above
clinical cutoffs on Overall Anxiety Severity and Impairment Scale (OASIS) or on the
Edinburgh Perinatal Depression Scale (EPDS), or on the Pregnancy Stress and Anxiety Scale
(PSAS) are eligible . A second screen using the Mini-Mental State Examination (MMSE) is
required , as CALM and CBT are only effective in specific conditions and is not recommended
for individuals with severe mental illness (e.g. bipolar disorder and psychosis) or
cognitive impairment.
Exclusion Criteria:
- Multiple gestation
- Serving as birth surrogate
- Used reproductive technology
Women will also be excluded if they do not meet the above criteria (i.e., they do not
exceed the clinical cutoffs) or if they have a history of bipolar disorder or psychosis
(treated within the past year).
We found this trial at
1
site
401 15th Street
Oakland, California 94612
Oakland, California 94612
Phone: 415-476-4040
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