CALM for Pregnant and Post-Partum Women

September 24, 2019 updated by: Christine Dunkel Schetter, PhD, University of California, Los Angeles

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CALM
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
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.
NO_INTERVENTION: Treatment as Usual
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)
Time Frame: at baseline, 12-weeks post-baseline, at 10 weeks postpartum
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)
Time Frame: at baseline, 12-weeks post-baseline, at 10 weeks postpartum
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)
Time Frame: at baseline, 12-weeks post-baseline, at 10 weeks postpartum
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
Time Frame: at baseline, 12-weeks post-baseline, and at 10 weeks postpartum
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
Time Frame: 12-weeks post-baseline
5 item Client Satisfaction questionnaire that measures a participants' satisfaction with the treatment they've been delivered
12-weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (ACTUAL)

November 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALM RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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