MomMoodBooster VA Program

NCT05196152 | Completed

• 2 other identifiers: 202102537202104724
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The MomMoodBooster intervention is an empirically validated treatment for postpartum depression symptoms. The intervention was created by Brian Danaher and Milagra Tyler, who have continued to update the intervention technology and content. The intervention is now available for pregnant and postpartum Veterans, and it is accessible on browsers via computer, tablet, or mobile phone. The intervention contains six cognitive-behavioral modules that span six weeks, and it includes identification of pleasant activities, tracking mood and thoughts, and identification of goals. The current trial is an expansion of a nationwide service delivery project that has been ongoing for six years with the goal of offering the intervention to postpartum Veterans nationwide. Within that study, Veterans completed the online modules in concert with weekly phone coaching calls wherein coaches applied the content to the Veteran's current life. In addition, two booster modules and associated coaching calls were developed to continue application of the skills beyond the six-week intervention period. The present study seeks to investigate the incremental utility of the phone coaching component of the intervention by randomizing pregnant and postpartum Veterans to the MomMoodBooster intervention or the MomMoodBooster intervention plus phone coaching. Primary outcomes will include depressive symptoms, behavioral activation, and negative automatic thoughts.

Conditions

Perinatal Depression; Postpartum Depression

Keywords

Postpartum Depression; Perinatal Depression; Veteran; Womens Mental Health

Outcome Measures

Primary Outcomes (3)

• Change in Depressive Symptoms

  Symptoms of dysphoria, anhedonia, avolition, suicidality, lassitude, and changes in sleep and appetite are measured. The measure being utilized is the Inventory of Depression and Anxiety Symptoms, version 2 (IDAS-II). The 99 items are rated on a 5-point Likert scale from Not At All to Extremely. The measure of depressive symptoms used for this outcome is a 20-item composite, General Depression, and higher scores represent higher levels of depressive symptoms. Scores range from 20-100.

  Through study completion, an average of 6 months

• Change in Behavioral Activation

  The Behavioral Activation for Depression Scale, short form (BADS), assesses engagement with valued life domains. The scale has four subscales, including activation, avoidance/rumination, work/school impairment, and social impairment. The 25 items are rated on a 0-6 Likert scale, and items from the avoidance, work/school, and social subscales are reverse-scored. Total scores range from 0-150, with higher scores indicating higher engagement with personal values.

  Through study completion, an average of 6 months

• Change in Negative Automatic Thoughts

  This measure assesses the frequency of negative automatic thoughts. The 15 items are rated on a 1-4 Likert scale. Total scores range from 15-60, with higher scores indicating more frequent negative automatic thoughts.

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Change in Anxiety Symptoms

  Through study completion, an average of 6 months

• Change in Dyadic Adjustment

  Through study completion, an average of 6 months

Other Outcomes (1)

• Program satisfaction

  6 months

Study Arms (2)

MomMoodBooster Online

ACTIVE COMPARATOR

Behavioral: MomMoodBooster

MomMoodBooster + Coach

EXPERIMENTAL

Behavioral: MomMoodBooster; Behavioral: Phone Coaching

Interventions

MomMoodBooster BEHAVIORAL

MomMoodBooster is an empirically validated online intervention for perinatal women.

MomMoodBooster + Coach; MomMoodBooster Online

Phone Coaching BEHAVIORAL

Phone coaching calls occur weekly in conjunction with MomMoodBooster online modules.

MomMoodBooster + Coach

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Currently pregnant or within 26 weeks postpartum
• years of age
• Experiencing elevated depressive symptoms at screening (PHQ-9 score of 10 or more)
• Have access to internet or smartphone

You may not qualify if:

• Past or current mania
• Current hypomania
• Past or current psychoses
• Active suicidality

Sponsors & Collaborators

• University of Iowa: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (7)

• Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Kosty DB, Lewinsohn P. MomMoodBooster web-based intervention for postpartum depression: feasibility trial results. J Med Internet Res. 2013 Nov 4;15(11):e242. doi: 10.2196/jmir.2876.

  PMID: 24191345 BACKGROUND

• Kroska EB, Stowe ZN. Postpartum Depression: Identification and Treatment in the Clinic Setting. Obstet Gynecol Clin North Am. 2020 Sep;47(3):409-419. doi: 10.1016/j.ogc.2020.05.001.

  PMID: 32762926 BACKGROUND

• Watson D, O'Hara MW, Naragon-Gainey K, Koffel E, Chmielewski M, Kotov R, Stasik SM, Ruggero CJ. Development and validation of new anxiety and bipolar symptom scales for an expanded version of the IDAS (the IDAS-II). Assessment. 2012 Dec;19(4):399-420. doi: 10.1177/1073191112449857. Epub 2012 Jul 20.

  PMID: 22822173 BACKGROUND

• Fuhr K, Hautzinger M, Krisch K, Berking M, Ebert DD. Validation of the Behavioral Activation for Depression Scale (BADS)-Psychometric properties of the long and short form. Compr Psychiatry. 2016 Apr;66:209-18. doi: 10.1016/j.comppsych.2016.02.004. Epub 2016 Feb 9.

  PMID: 26995255 BACKGROUND

• Solness CL, Kroska EB, Holdefer PJ, O'Hara MW. Treating postpartum depression in rural veterans using internet delivered CBT: program evaluation of MomMoodBooster. J Behav Med. 2021 Aug;44(4):454-466. doi: 10.1007/s10865-020-00188-5. Epub 2020 Oct 14.

  PMID: 33052526 BACKGROUND

• Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Lewinsohn P. Web-Based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program. JMIR Res Protoc. 2012 Nov 22;1(2):e18. doi: 10.2196/resprot.2329.

  PMID: 23612274 BACKGROUND

• Netemeyer, R. G., Williamson, D. A., Burton, S., Biswas, D., Jindal, S., Landreth, S., et al. (2002). Psychometric properties of shortened versions of the Automatic Thoughts Questionnaire. Educational and Psychological Measurement, 62, 111-129. https://doi.org/10.1177/0013164402062001008

  BACKGROUND

Related Links

• MomMoodBooster

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

• Emily BK Thomas, PhD

  University of Iowa; Rural Health Resource Center - Iowa City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Participants are assigned to either: 1) MomMoodBooster or 2) MomMoodBooster + phone coaching.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 19, 2022
• Study Start: March 3, 2022
• Primary Completion: December 19, 2023
• Study Completion: January 14, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)