CALM for Pregnant and Post-Partum Women

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: Pregnancy Specific Anxiety 4 items Scale (cut off 15 or higher) 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.

Official Title
-----------------
A Randomized Controlled Trial of Coordinated Anxiety Learning and Management (CALM) for Pregnant and Postpartum Women

Conditions
-----------------
Anxiety, Depression, Depression, Postpartum, Pregnancy Related, CBT

Intervention / Treatment
-----------------
* Behavioral: Coordinated Anxiety Learning and Management


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be recruited and randomized to the CALM intervention delivered in their homes or to treatment as usual.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM<br>The intervention for this study, CALM Tools for Living-Il, is a computer-assisted cognitive-behavioral therapy for anxiety and depression that guides both the patient and CALM specialist. It is a reformulation of CALM Tools for Living that directly incorporates our previously optional modules for depression into the main program. The computerized/internet format is designed to retain the fidelity of CBT when delivered by novice clinicians. The program is intended to be delivered in 6 to 8 sessions, although flexibility is allowed. Participants in the intervention group will be visited by the calm specialist weekly between 6 and 8 times prenatally;postpartum visits will vary based on continuing assessment of symptoms. | Behavioral: Coordinated Anxiety Learning and Management<br>* The intervention for this study, CALM Tools for Living-Il, is a computer-assisted cognitive behavioral therapy for anxiety and depression that guides both the patient and CALM specialist. It is a reformulation of CALM Tools for Living42 that directly incorporates our previously optional modules for depression into the main program. The computerized internet format is designed to retain the fidelity of CBT when delivered by novice clinicians. The program is intended to be delivered in 6 to 8 sessions, although flexibility is allowed.<br>|
| No Intervention: Treatment as Usual<br>Participants will receive pre-natal care as usual, and will be visited at 4 time points by the graduate student researchers: baseline, 12 weeks post baseline, and 10 weeks postpartum. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pregnancy Related Anxiety (composite will be created with anxiety and depression measures) | 14 item Pregnancy Stress and Anxiety Scale (PSAS) that measures pregnancy related stress and anxiety | at baseline, 12-weeks post-baseline, at 10 weeks postpartum | 
| Change in General Anxiety (composite will be created with anxiety and depression measures) | 14 items from the Anxiety and Stress subscales of the Depression, Anxiety and Stress Scale (DASS) | at baseline, 12-weeks post-baseline, at 10 weeks postpartum | 
| Change in Depression (composite will be created with anxiety and depression measures) | 10 items from the Edinburgh Postnatal Depression Scale (EPDS) that measures postnatal depressive symptoms | at baseline, 12-weeks post-baseline, at 10 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Impairment | 5 item Sheehan Disability Scale (SDS) that measures functional impairment in school/ work, social, and family life (0-10 with higher scores indicating more impairment) and 2 items assessing number of days in one week participant felt were lost or unproductive due to symptoms of anxiety or depression (1-7). | at baseline, 12-weeks post-baseline, and at 10 weeks postpartum | 
| Treatment Satisfaction | 5 item Client Satisfaction questionnaire that measures a participants' satisfaction with the treatment they've been delivered | 12-weeks post-baseline |