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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group dance fitness, OULA | Experimental | Mind-body dance fitness group |
|
| Waitlist Control | No Intervention | Waitlist control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OULA, Mind-body Physical Activity | Other | Group dance fitness program with focus on the mind-body connection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in postpartum anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Hellem, PhD | Contact | 406-243-2110 | tracy.hellem1@montana.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tracy Hellem, PhD | Montana State University | Principal Investigator |
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Data obtained through this study may be provided to qualified researchers with academic interest in mind-body physical activity interventions for postpartum depression. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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 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).
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Postpartum Specific Anxiety Scale Research Short Form will be used at baseline, weeks 4, 8, and 10 to evaluate postpartum anxiety.
| 7 months |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |