Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention
ConditionPostpartum Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called "Preventing Postpartum Onset Distress", or P-POD. The overarching goal of this study is to conduct a randomized control trial of P-POD, an online program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. Investigators will test the effects of P-POD compared to an anxiety education control intervention on risk factors for perinatal anxiety and assess mothers' anxiety symptoms, relationships with their partners, and relationships with their infants at 8-weeks postpartum. Eligible women and their partners will be consented at the start of the second trimester of pregnancy. Couples will be randomized into either the P-POD (active) or ANX-ED (control) intervention. Couples will then begin to work through the ten intervention modules: seven modules for women, at a recommended rate of one per week, and three modules for partners, at a recommended rate of no more than one per week. Women will complete brief weekly phone "coaching calls" to encourage module completion, ensure understanding of material, and answer any content-related or technical questions. Ten weeks after the pre-intervention assessment, women will complete the post-intervention assessment (same measures as pre-assessment).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant and entering second trimester
In a romantic relationship
Partner must be agreeable to participate
State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Preventing Postpartum Onset Distress (P-POD)
BehavioralP-POD contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules are designed to educate pregnant women about perinatal anxiety (psychoeducation), teach women to change their thinking patterns (cognitive restructuring), and guide women through testing their dysfunctional beliefs and fears (behavioral experiments). Each of these modules engage the pregnant woman in various self-guided exercises to consolidate the lessons learned. In addition, three partner-directed modules are designed to educate partners about perinatal anxiety, coach partners on providing emotional and social supports to pregnant women at risk for perinatal anxiety, and prepare partners for developmentally normative changes in their relationships following birth. Modules are designed to be completed weekly during the second trimester.
Anxiety Education (ANX-ED)
BehavioralANX-ED educates women and their partners about seven anxiety and related disorders. ANX-ED contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules and three partner-directed modules will educate participants about generalized anxiety disorder, social anxiety disorder, panic disorder, specific phobia, obsessive-compulsive disorder, and posttraumatic stress disorder. Specifically, modules will include the diagnostic criteria, prevalence, and etiology of the disorders. They will also include animated examples of mothers experiencing the disorders described in each module. Each module engages the pregnant woman (or partner) in various self-guided exercises to consolidate the material learned.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Preventing Postpartum Onset Distress (P-POD)Experimental treatment 1 intervention
Group B: Anxiety Education (ANX-ED)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)
Change in STAI-Trait score. This is a 20-item self-report used to assess dispositional levels of anxiety. It is widely used, sensitive to treatment, has strong psychometric properties, and includes items that would be relevant to pregnant women. The STAI-Trait Total Score will be used before and after P-POD to assess change in prenatal trait anxiety. The STAI-Trait total score ranges from 20 to 80. Higher numbers represent more anxiety (worse outcome).
Time frame
Change from Baseline to Week 102
Change in Obsessive Beliefs Questionnaire (OBQ)
Change in Obsessive Beliefs Questionnaire (OBQ) score. This measure assesses dysfunctional beliefs related to OCD in 44 items on a 7-point Likert-type scale, with items summed; higher scores indicate more dysfunctional beliefs. The OBQ has strong psychometric properties and has demonstrated sensitivity to treatment with pregnant women.
Time frame
Change from Baseline to Week 10Secondary outcomes
1
Change in Perinatal Interpretations Questionnaire (PIQ)
The PIQ will be administered to assess change in negative interpretations. This measure asks participants to read and imagine themselves in two scenarios (e.g., not checking on baby while he/she sleeps) and then rate the likelihood of eight interpretations related to each scenario (e.g., "your baby is not safe") on a 5-point Likert-type response scale. The 16 items are summed, higher scores indicate more negative perinatal interpretations.
Time frame
Change from Baseline to Week 102
Change in Social Provisions Checklist (SPC)
The SPC will be administered to assess change in partner support. This measure asks participants to rate the extent to which they receive different benefits (e.g., emotional closeness) from their romantic partner. It consists of 30 items on a 5-point Likert-type scale; items are summed and higher scores indicate more perceived support. The SPC has strong internal reliability and construct validity.
Time frame
Change from Baseline to 8-weeks postpartum3
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS will be administered to assess severity of postpartum anxiety. This 5-item self-report of anxiety symptom severity and impairment has strong reliability, convergent validity, and discriminant validity in both nonclinical and clinical samples, is sensitive to treatment and has been used with perinatal women. Items are scored on a 5-point scale and summed; higher scores are indicative of higher symptom severity and impairment.
Time frame
8-weeks postpartum4
Dimensional Obsessive-Compulsive Scale (DOCS)
The DOCS will be administered to assess severity of postpartum OCD symptoms. This 20-item self-report of OCD symptom severity has good internal consistency, construct validity, discriminant validity, and sensitivity to treatment, and has been recommended for use in pregnant women. Items are rated on a 5-point Likert-type scale and are summed; higher numbers are indicative of higher symptom severity.
Time frame
8-weeks postpartumSponsors and contacts
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West Virginia University
Lead sponsor
University of Vermont
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
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