A Randomized Controlled Trial of Coordinated Anxiety Learning and Management (CALM) for Pregnant and Postpartum Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Change in Depression (composite will be created with anxiety and depression measures)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
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.
Intervention: Coordinated Anxiety Learning and Management (Behavioral)
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.
Outcomes
Primary Outcomes
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
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
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)
Secondary Outcomes
- Change in Functional Impairment(at baseline, 12-weeks post-baseline, and at 10 weeks postpartum)
- Treatment Satisfaction(12-weeks post-baseline)
Investigators
Christine Dunkel Schetter, PhD
Principal Investigator
University of California, Los Angeles