Feasibility Evaluation of a Dance Fitness Program

NCT ID: NCT06273423

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group dance fitness, OULA

Mind-body dance fitness group

Group Type EXPERIMENTAL

OULA, Mind-body Physical Activity

Intervention Type OTHER

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

Waitlist Control

Waitlist control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OULA, Mind-body Physical Activity

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Montana State University

OTHER

Sponsor Role lead

Responsible Party

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Tracy Hellem

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracy Hellem, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Central Contacts

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Tracy Hellem, PhD

Role: CONTACT

406-243-2110

Other Identifiers

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OULA for Postpartum Depression

Identifier Type: -

Identifier Source: org_study_id

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