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Feasibility Evaluation of a Dance Fitness Program

Montana State University logo

Montana State University

Status

Not yet enrolling

Conditions

Postpartum Depression

Treatments

Other: OULA, Mind-body Physical Activity

Study type

Interventional

Funder types

Other

Identifiers

NCT06273423
OULA for Postpartum Depression

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

20 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Group dance fitness, OULA
Experimental group
Description:
Mind-body dance fitness group
Treatment:
Other: OULA, Mind-body Physical Activity
Waitlist Control
No Intervention group
Description:
Waitlist control group

Trial contacts and locations

0

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Central trial contact

Tracy Hellem, PhD

Data sourced from clinicaltrials.gov

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