Feasibility Evaluation of a Dance Fitness Program

NCT06273423 | Not Yet Recruiting DMC

• 1 other identifier: OULA for Postpartum Depression
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postpartum Depression

Keywords

Postpartum; Depression; Mind-body; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in postpartum depression

  7 months

• Changes in postpartum anxiety

  7 months

Study Arms (2)

Group dance fitness, OULA

EXPERIMENTAL

Mind-body dance fitness group

Other: OULA, Mind-body Physical Activity

Waitlist Control

NO INTERVENTION

Waitlist control group

Interventions

OULA, Mind-body Physical Activity OTHER

Group dance fitness program with focus on the mind-body connection

Group dance fitness, OULA

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead

MeSH Terms

Conditions

Depression, Postpartum; Depression; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Tracy Hellem, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Hellem, PhD

CONTACT

406-243-2110; tracy.hellem1@montana.edu

Study Design

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

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 22, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).