Walk With Me (WWM) for Perinatal Grief

Browse trials for

• Stress Disorders, Post-Traumatic 2,682
• Suicidal Ideation 569
• Abortion, Spontaneous 221
• Stillbirth 121
• Infant Death 51

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 300 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc. is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Study arms

• No intervention
  Services as Usual

  Services as usual received by referral or identified by the participant

• Experimental
  Along With Me Web-Based Intervention

  Web-based tool that offers therapeutic support modules with information that leverages cognitive behavioral therapy and mindfulness strategies. The web-based tool includes 10 modules and also includes a list of resources and journaling feature.

  Behavioral: Along With Me

• Experimental
  Along With Me Web-Based Intervention Plus Peer Guide Support

  Web-based tool plus support from a Peer Guide.

  Behavioral: Along With Me · Behavioral: Peer Guide

Interventions

• BehavioralAlong With Me

  Along With Me is a therapeutic app that delivers cognitive behavior therapy and mindfulness-based psychoeducation and skills, grief normalization, and exercises to address perinatal grief and to reduce trauma symptoms related to the experience of perinatal loss. The Along With Me only arm will deliver the app-based intervention only.

• BehavioralPeer Guide

  The peer guide will provide light touch reminders, opportunities to debrief, and resource navigation support, similar to community health navigator interventions provided remotely through insurers.

Primary outcomes

1. PTSD Checklist for DSM-5 (PCL-5)

   The PCL-5 is a widely used self-report measure for assessing PTSD symptoms based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria (DSM-5). There are 20 self-report items, and each item is rated on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"). A sum score is computed and can range from 0 to 80, with higher scores indicating greater PTSD symptom severity.

   Time frame: Baseline, 3,6,9 months post-baseline

2. Suicide Cognitions Scale (SCS-R)

   The SCS-R is a 16-item self-report measure designed to assess suicidogenic cognitions-beliefs and perceptions that increase vulnerability to suicidal behavior. The response option utilizes a 0-4 Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree). A sum score is computed, resulting in a total score range of 0 to 64. Higher scores indicate stronger endorsement of maladaptive cognitions associated with suicide risk.

   Time frame: Baseline, 3,6,9 months post-baseline

3. Columiba Suicide Severity Rating Scale (C-SSRS)

   The Columbia-Suicide Severity Rating Scale (C-SSRS) is a 6-item structured set of questions used to assess suicidal ideation (5 items listed from least to most severe) and suicidal behavior (1 item). It is designed to help determine whether suicide-related thoughts/behaviors are present, and if so, their severity and clinical urgency, using standardized definitions and prompts. Response options are on a "yes" and "no" format. Clinically, you use the highest ideation category endorsed (1-5) as the ideation severity indicator and higher scores indicate greater levels of suicidal ideation. The suidial behavior item is a stand alone item indicating presense (=yes) or absence (=no) of any suicidal behavior.

   Time frame: Baseline, 3, 6, and 9 moths post-baseline

Secondary outcomes

1. Generalized Anxiety Disorder 2-item scale (GAD-2)

   The GAD-2 is a brief screening tool for generalized anxiety disorder, made up of the first two items of the longer GAD-7. It's designed as a fast, first-pass screen for anxiety in primary care and research settings. Respondents rate how often they've been bothered by each symptom over the past two weeks using a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total sum score ranges from 0 to 6, with higher scores indicating greater severity of anxiety symptoms.

   Time frame: 3, 6, 9 months post-baseline

2. Patient Health Questionnaire-2 (PHQ-2)

   The PHQ-2 is a brief screening tool for depression, made up of the first two items of the longer PHQ--9. It's designed as a fast, first-pass screen for anxiety in primary care and research settings. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total sum score ranges from 0 to 3, with higher scores indicating greater severity of depression.

   Time frame: 3,6,9 months post-baseline

3. Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool

   The TAPS Tool is a brief assessment instrument designed to identify problematic substance use and substance use disorders, consisting of 3-4 items per substance class, evaluating past 3-month usage (=1), problems related to use (=1), and concerns expressed by others (=1). Score for alcohol can range from 0-4, and other substances from 0-3. Scores greater than 1 indicate problematic use, and scores greater than 2 indicate a potential substance use disorder.

   Time frame: 3,6,9 months post-baseline

4. Perintal Grief Scale (PGS)

   The Perinatal Grief Scale (PGS) is a 33-item brief version was developed to quantify grief reactions following perinatal loss, including losses due to spontaneous abortion, fetal or neonatal death, or ectopic pregnancy. Response options are on a 5-point Likert-type scale (1 = strongly agree, 5 = strongly disagree). All but two items (item 11 and 33) are reveresed scored and three grief subdomain sum scores created: Active Grief (11items), Difficulty Coping (11 items), and Despair (11 items). Subdomain scores can range from 11 to 55 with higher scores indicating higher levels of grief.

   Time frame: Baseline, 3, 6, and 9 months post-baseline.

Individual participant data

Plan to share: Yes — Study data will be accessible through openICPSR's Search function by topic (e.g., maternal health). Other researchers will be able to see a study description and a link to download data and documentation files. openICPSR provides a DOI number for each data upload such that published study results will be linked to the exact data used and allows depositors to update data files and metadata at any time. Survey Data: De-identified individual and aggregate survey data (raw and recoded) will be shared. The de-identification process will remove direct and indirect respondent identifiers. Once data are confirmed final, respondent identifiers will be deleted.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Project data and documentation will be uploaded into openICPSR at the time of initial publication, or by the end of the research project period, whichever occurs first. If publication occurs prior to the project's end, researchers will utilize the version update DOI process to maintain data sharing transparency for published study results and supporting data. A complete, deidentified project data set and all supporting documentation will resided on openICPSR as the final data version when the project concludes. Researchers anticipate having project data available in openICPSR for 5 years after the project ends.

Access criteria: To meet data sharing requirement for our study data and documentation, we have selected the openICPSR repository.