Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667520
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-11-12
Brief Title:
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Status:
RECRUITING
Status Verified Date:
2024-03
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:
HEART
Brief Summary:
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity LPA intervention for preventing relapse among women with depression engaged in alcohol treatment Participants are randomized to either 1 LPAFitbit intervention or 2 Fitbit Only control condition Follow-up assessments and EMA data will be collected
Detailed Description:
Alcohol use disorder AUD is a significant and costly public health problem that affects one-third of the US population in their lifetime Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men Physical activity PA interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity LPA intervention for preventing relapse among women with depression engaged in alcohol treatment A total of 214 women from the Alcohol and Drug Partial Hospitalization Program ADP at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a 1 LPAFitbit intervention or 2 Fitbit Only control condition Follow-up assessments will occur at 6-weeks end of treatment EOT at 3 months and 6 9 and 12 months Participants will also complete 3 10-day periods of ecological momentary assessment EMA during early recovery at approximately weeks 1 2 5 6 and again at weeks 11 12
The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity LPA intervention for preventing relapse among women with depression engaged in alcohol treatment A total of 214 women from the Alcohol and Drug Partial Hospitalization Program ADP at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a 1 LPAFitbit intervention or 2 Fitbit Only control condition Follow-up assessments will occur at 6-weeks end of treatment EOT at 3 months and 6 9 and 12 months Participants will also complete 3 10-day periods of ecological momentary assessment EMA during early recovery at approximately weeks 1 2 5 6 and again at weeks 11 12
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA028186 | NIH | None | httpsreporternihgovquickSearchR01AA028186 |