Feasibility Evaluation of a Dance Fitness Program

Postpartum Depression Clinical Trial

Official title:

A Feasibility Randomized Controlled Evaluation of a Mind-Body Dance Fitness Program for Improving Symptoms of Postpartum Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273423
• Other study ID #: OULA for Postpartum Depression
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Montana State University
• Contact: Tracy Hellem, PhD
• Phone: 406-243-2110
• Email: tracy.hellem1[@]montana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Other:
• OULA, Mind-body Physical Activity
Group dance fitness program with focus on the mind-body connection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montana State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability	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.	7 months
Secondary	Changes in postpartum depression	The Edinburgh Postnatal Depression Scale will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum depression.	7 months
Secondary	Changes in postpartum anxiety	Postpartum Specific Anxiety Scale Research Short Form will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum anxiety.	7 months