Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462391
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-16
Brief Title:
Adapting and Piloting Acceptance and Commitment Therapy ACT for Severe Premenstrual Mood Symptoms
Sponsor:
Womens College Hospital
Organization:
Womens College Hospital
Study Overview
Official Title:
Adapting and Piloting Acceptance and Commitment Therapy ACT for Severe Premenstrual Mood Symptoms An Open-label Feasibility Study of ACT-PM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT-PM
Brief Summary:
In the weeks prior to menstruation many individuals experience mood and physical symptoms that negatively impact their quality of life and functioning Approximately 5 of women and menstruating individuals have such severe symptoms that they meet criteria for Premenstrual Dysphoric Disorder PMDD Further of those with underlying mood disorders ie depression bipolar disorder about 60 have cyclical worsening of symptoms classified as premenstrual exacerbation PME Both PMDD and PME are associated with significant impairment yet limited effective options exist to treat these conditions In this project the investigators will adapt and evaluate an Acceptance and Commitment Therapy ACT group for PMDD and PME entitled ACT-Premenstrual ACT-PM delivered virtually to maximize accessibility The investigators will examine whether ACT-PM is feasible to deliver and whether it is acceptable to group participants and those facilitating the group The study will lay the groundwork for future research to determine if the group is effective If effective the intervention could be scaled up to improve quality of life and outcomes for individuals suffering from PMDD and PME
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None