CALM for Pregnant and Post-Partum Women

NCT03351465 | Withdrawn

• 1 other identifier: CALM RCT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Depression, Postpartum; Pregnancy Related; CBT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Functional Impairment

  at baseline, 12-weeks post-baseline, and at 10 weeks postpartum

• Treatment Satisfaction

  12-weeks post-baseline

Study Arms (2)

CALM

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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.

Interventions

Coordinated Anxiety Learning and Management BEHAVIORAL

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.

CALM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, San Francisco

Oakland, California, 94612, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Anxiety Disorders; Depression; Depression, Postpartum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be recruited and randomized to the CALM intervention delivered in their homes or to treatment as usual.

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 22, 2017
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)