AnxietyNCT03351465
CALM for Pregnant and Post-Partum Women
A study testing Coordinated Anxiety Learning and Management in people with Anxiety and Depression, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Depression, Postpartum
- What is being tested?
- Coordinated Anxiety Learning and Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
Oakland, California, 94612
About this study
Official title: 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.
Read the 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)
- 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.
- Conditions
- Anxiety, Depression, Depression, Postpartum, Pregnancy Related, CBT
- Being tested
- Coordinated Anxiety Learning and Management
- Medical subject headings
- Anxiety Disorders, Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated Anxiety Learning and ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: at baseline, 12-weeks post-baseline, at 10 weeks postpartum
Secondary outcomes (2)
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).
Measured: 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
Measured: 12-weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Jan 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Why it stopped: Trial was suspended due unanticipated funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited and randomized to the CALM intervention delivered in their homes or to treatment as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Christine Dunkel Schetter, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351465
- Sponsor's protocol ID
- CALM RCT
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dunkel Schetter C. Psychological science on pregnancy: stress processes, biopsychosocial models, and emerging research issues. Annu Rev Psychol. 2011;62:531-58. doi: 10.1146/annurev.psych.031809.130727.
PubMed 21126184Huizink AC, Mulder EJ, Buitelaar JK. Prenatal stress and risk for psychopathology: specific effects or induction of general susceptibility? Psychol Bull. 2004 Jan;130(1):115-42. doi: 10.1037/0033-2909.130.1.115.
PubMed 14717652Dole N, Savitz DA, Hertz-Picciotto I, Siega-Riz AM, McMahon MJ, Buekens P. Maternal stress and preterm birth. Am J Epidemiol. 2003 Jan 1;157(1):14-24. doi: 10.1093/aje/kwf176.
PubMed 12505886Kramer MS, Lydon J, Seguin L, Goulet L, Kahn SR, McNamara H, Genest J, Dassa C, Chen MF, Sharma S, Meaney MJ, Thomson S, Van Uum S, Koren G, Dahhou M, Lamoureux J, Platt RW. Stress pathways to spontaneous preterm birth: the role of stressors, psychological distress, and stress hormones. Am J Epidemiol. 2009 Jun 1;169(11):1319-26. doi: 10.1093/aje/kwp061. Epub 2009 Apr 10.
PubMed 19363098Orr ST, Reiter JP, Blazer DG, James SA. Maternal prenatal pregnancy-related anxiety and spontaneous preterm birth in Baltimore, Maryland. Psychosom Med. 2007 Jul-Aug;69(6):566-70. doi: 10.1097/PSY.0b013e3180cac25d. Epub 2007 Jul 16.
PubMed 17636150Andersson L, Sundstrom-Poromaa I, Bixo M, Wulff M, Bondestam K, aStrom M. Point prevalence of psychiatric disorders during the second trimester of pregnancy: a population-based study. Am J Obstet Gynecol. 2003 Jul;189(1):148-54. doi: 10.1067/mob.2003.336.
PubMed 12861154Ross LE, McLean LM. Anxiety disorders during pregnancy and the postpartum period: A systematic review. J Clin Psychiatry. 2006 Aug;67(8):1285-98. doi: 10.4088/jcp.v67n0818.
PubMed 16965210Lee AM, Lam SK, Sze Mun Lau SM, Chong CS, Chui HW, Fong DY. Prevalence, course, and risk factors for antenatal anxiety and depression. Obstet Gynecol. 2007 Nov;110(5):1102-12. doi: 10.1097/01.AOG.0000287065.59491.70.
PubMed 17978126Teixeira C, Figueiredo B, Conde A, Pacheco A, Costa R. Anxiety and depression during pregnancy in women and men. J Affect Disord. 2009 Dec;119(1-3):142-8. doi: 10.1016/j.jad.2009.03.005. Epub 2009 Apr 5.
PubMed 19346001Woods SM, Melville JL, Guo Y, Fan MY, Gavin A. Psychosocial stress during pregnancy. Am J Obstet Gynecol. 2010 Jan;202(1):61.e1-7. doi: 10.1016/j.ajog.2009.07.041. Epub 2009 Sep 20.
PubMed 19766975Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
PubMed 16260528Goodman SH. Depression in mothers. Annu Rev Clin Psychol. 2007;3:107-35. doi: 10.1146/annurev.clinpsy.3.022806.091401.
PubMed 17716050Bener A, Gerber LM, Sheikh J. Prevalence of psychiatric disorders and associated risk factors in women during their postpartum period: a major public health problem and global comparison. Int J Womens Health. 2012;4:191-200. doi: 10.2147/IJWH.S29380. Epub 2012 May 10.
PubMed 22654524Matthey S, Barnett B, Howie P, Kavanagh DJ. Diagnosing postpartum depression in mothers and fathers: whatever happened to anxiety? J Affect Disord. 2003 Apr;74(2):139-47. doi: 10.1016/s0165-0327(02)00012-5.
PubMed 12706515Yelland J, Sutherland G, Brown SJ. Postpartum anxiety, depression and social health: findings from a population-based survey of Australian women. BMC Public Health. 2010 Dec 20;10:771. doi: 10.1186/1471-2458-10-771.
PubMed 21167078
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Coordinated Anxiety Learning and Management (CALM) for Pregnant and Postpartum Women
- ClinicalTrials.gov ID
- NCT03351465
- Acronym / sponsor ID
- CALM RCT
- Conditions
- Anxiety, Depression, Depression, Postpartum, Pregnancy Related, CBT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was suspended due unanticipated funding issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be recruited and randomized to the CALM intervention delivered in their homes or to treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| CALM | Experimental | Behavioral: Coordinated Anxiety Learning and ManagementThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coordinated Anxiety Learning and ManagementThe 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. | Behavioural | CALM |
Primary outcome
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)
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
2 secondary outcomes
Change in Functional Impairment
Time frame: at baseline, 12-weeks post-baseline, and at 10 weeks postpartum
Treatment Satisfaction
Time frame: 12-weeks post-baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 21126184Dunkel Schetter C. Psychological science on pregnancy: stress processes, biopsychosocial models, and emerging research issues. Annu Rev Psychol. 2011;62:531-58. doi: 10.1146/annurev.psych.031809.130727.
- Background: PubMed 14717652Huizink AC, Mulder EJ, Buitelaar JK. Prenatal stress and risk for psychopathology: specific effects or induction of general susceptibility? Psychol Bull. 2004 Jan;130(1):115-42. doi: 10.1037/0033-2909.130.1.115.
- Background: PubMed 12505886Dole N, Savitz DA, Hertz-Picciotto I, Siega-Riz AM, McMahon MJ, Buekens P. Maternal stress and preterm birth. Am J Epidemiol. 2003 Jan 1;157(1):14-24. doi: 10.1093/aje/kwf176.
- Background: PubMed 19363098Kramer MS, Lydon J, Seguin L, Goulet L, Kahn SR, McNamara H, Genest J, Dassa C, Chen MF, Sharma S, Meaney MJ, Thomson S, Van Uum S, Koren G, Dahhou M, Lamoureux J, Platt RW. Stress pathways to spontaneous preterm birth: the role of stressors, psychological distress, and stress hormones. Am J Epidemiol. 2009 Jun 1;169(11):1319-26. doi: 10.1093/aje/kwp061. Epub 2009 Apr 10.
- Background: PubMed 17636150Orr ST, Reiter JP, Blazer DG, James SA. Maternal prenatal pregnancy-related anxiety and spontaneous preterm birth in Baltimore, Maryland. Psychosom Med. 2007 Jul-Aug;69(6):566-70. doi: 10.1097/PSY.0b013e3180cac25d. Epub 2007 Jul 16.
- Background: PubMed 12861154Andersson L, Sundstrom-Poromaa I, Bixo M, Wulff M, Bondestam K, aStrom M. Point prevalence of psychiatric disorders during the second trimester of pregnancy: a population-based study. Am J Obstet Gynecol. 2003 Jul;189(1):148-54. doi: 10.1067/mob.2003.336.
- Background: PubMed 16965210Ross LE, McLean LM. Anxiety disorders during pregnancy and the postpartum period: A systematic review. J Clin Psychiatry. 2006 Aug;67(8):1285-98. doi: 10.4088/jcp.v67n0818.
- Background: PubMed 17978126Lee AM, Lam SK, Sze Mun Lau SM, Chong CS, Chui HW, Fong DY. Prevalence, course, and risk factors for antenatal anxiety and depression. Obstet Gynecol. 2007 Nov;110(5):1102-12. doi: 10.1097/01.AOG.0000287065.59491.70.
- Background: PubMed 19346001Teixeira C, Figueiredo B, Conde A, Pacheco A, Costa R. Anxiety and depression during pregnancy in women and men. J Affect Disord. 2009 Dec;119(1-3):142-8. doi: 10.1016/j.jad.2009.03.005. Epub 2009 Apr 5.
- Background: PubMed 19766975Woods SM, Melville JL, Guo Y, Fan MY, Gavin A. Psychosocial stress during pregnancy. Am J Obstet Gynecol. 2010 Jan;202(1):61.e1-7. doi: 10.1016/j.ajog.2009.07.041. Epub 2009 Sep 20.
- Background: PubMed 16260528Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
- Background: PubMed 17716050Goodman SH. Depression in mothers. Annu Rev Clin Psychol. 2007;3:107-35. doi: 10.1146/annurev.clinpsy.3.022806.091401.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated Anxiety Learning and Management in people with Anxiety and Depression, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351465, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.