Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336616
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-27
Brief Title:
Getting Out of the House Using Behavioral Activation to Increase Community Participation
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Getting Out of the House A Behavioral Activation Approach to Support Community Participation With Individuals With Serious Mental Illness
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness
The overall objective of this study is to increase engagement in meaningful activities and community participation The objectives of the project are as follows
1 To determine if the intervention leads to increases the frequency and variety of activities
2 To determine if the intervention leads to increases in community mobility
3 To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention
4 To determine if the the intervention leads to an improvement in overall well-being eg improved quality of life
Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period
For data collection participants will also be asked to
1 Complete three approximately 1-hour interviews at baseline after the 10 week intervention and again at the end of the maintenance period
2 Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time at three separate times eg baseline after the intervention and at the end of the maintenance period and
3 Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation
The study will enroll 52 participants split into 4 cohorts of 13 The study will use a multiple baseline design and as such all participants will receive the intervention and there is no control group
The overall objective of this study is to increase engagement in meaningful activities and community participation The objectives of the project are as follows
1 To determine if the intervention leads to increases the frequency and variety of activities
2 To determine if the intervention leads to increases in community mobility
3 To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention
4 To determine if the the intervention leads to an improvement in overall well-being eg improved quality of life
Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period
For data collection participants will also be asked to
1 Complete three approximately 1-hour interviews at baseline after the 10 week intervention and again at the end of the maintenance period
2 Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time at three separate times eg baseline after the intervention and at the end of the maintenance period and
3 Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation
The study will enroll 52 participants split into 4 cohorts of 13 The study will use a multiple baseline design and as such all participants will receive the intervention and there is no control group
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