Feasibility Evaluation of a Dance Fitness Program

Not Applicable

Not yet recruiting

• Conditions: Postpartum Depression
• Interventions: Other: OULA, Mind-body Physical Activity

• Registration Number: NCT06273423
• Lead Sponsor: Montana State University

Brief Summary

The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).

Detailed Description

The proposed project is a pilot two-arm randomized controlled trial (RCT), with specific aims to evaluate the feasibility and acceptability of implementing an RCT of OULA (named after Missoula, MT) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of OULA or waitlist control.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Study Start: 2024-10
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Ages 20-39 years
• Have an infant 0-12 months old
• Self-report clearance from provider to engage in physical activity following birth
• Structured Clinical Interview for Diagnostic Statistical Manual-5-Research Version (SCID-5-RV) diagnosis of major depressive episode (MDE) with onset during pregnancy or 12 months following childbirth
• Edinburgh Postnatal Depression Scale (EPDS) score of 10 or above
• English speaking
• OULA-naïve
• If on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks

Exclusion Criteria

• Unable to be physically active
• Current pregnancy
• SCID-5-RV diagnosis of bipolar disorder, schizophrenia, or current substance use disorder
• Active suicidal attempt or plan identified on the SCID-5-RV
• Suicide attempt in the past 6 months
• Concurrent participation in another group dance fitness format
• No access to Internet via computer, tablet, or smart phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group dance fitness, OULA	OULA, Mind-body Physical Activity	Mind-body dance fitness group

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability	7 months	Feasibility will be evaluated using recruitment, retention, OULA attendance, and treatment completion data, amd intervention fidelity. Feasibility of recruitment will be assessed through the number of participants eligible for randomization, proportion of participants randomized relative to the total number of referrals, and number of participants enrolled each month. Feasibility of intervention will be evaluated through treatment completion and retention rates, Feasibility of Intervention Measure (FIM) will be used at intervention completion. Fidelity assessment will be measured by OULA instructors completing an self-evaluation checklist. Women in the OULA group will complete the 8-item Client Satisfaction Questionnaire (CSQ-8) will be collected at week 8. Acceptability will be assessed through reasons for withdrawal. Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) will be collected at week 8.

Secondary Outcome Measures

Name	Time	Method
Changes in postpartum depression	7 months	The Edinburgh Postnatal Depression Scale will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum depression.
Changes in postpartum anxiety	7 months	Postpartum Specific Anxiety Scale Research Short Form will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum anxiety.