Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639477
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Assessing Improvements in Mood and Sleep Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIMS
Brief Summary:
This is a multi-site randomized control trial involving people age 55 years who have current depression symptoms plus another suicide risk indicator either current suicidal ideation or a past history of attempt Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping bad moods and any suicidality
Participants will complete diagnostic interviews self-report scales and wear an actigraphy device for the 8 weeks starting at the baseline visit
Participants will complete diagnostic interviews self-report scales and wear an actigraphy device for the 8 weeks starting at the baseline visit
Detailed Description:
The main purpose of the study is to compare the effects of two approaches on sleep and mood including any symptoms of depression and suicidality There will be 420 people invited to participate across three sites in the United States University of Pittsburgh UCLA Augusta
Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes Each group will contain 210 participants Researchers will enroll a total of 140 participants 70 in each group at the University of Pittsburgh Both groups will meet with a study therapist once a week to complete the assigned 8-week program To determine which if any program has beneficial effect over time researchers will ask participants to complete assessments of their sleep mood and health before and after the therapy Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design
There are three main study visits where participants will complete assessments about their sleep mood cognition and health These would be
Before the therapy program begins
Right after it ends
Six months later
Around the time of each visit researchers will ask participants to wear an actigraphy watch on their wrist 247 for a week while completing a sleep diary The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participants activity and sleep levels
After the first main visit is complete participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks 8 sessions total Both groups will receive educational information and depending on the group the participants are assigned to may include guided discussions activities andor support addressing any stressors participants face sleep problems andor depression
During the therapy period researchers would ask participants to continue wearing the actigraphy watch Researchers would also ask participants to answer questions on the phone with study staff weekly that would take about 30-40 minutes a week
After the participants last therapy session researchers would repeat the phone assessments once a month until the last main visit occurs six-months after therapy ends
Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes Each group will contain 210 participants Researchers will enroll a total of 140 participants 70 in each group at the University of Pittsburgh Both groups will meet with a study therapist once a week to complete the assigned 8-week program To determine which if any program has beneficial effect over time researchers will ask participants to complete assessments of their sleep mood and health before and after the therapy Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design
There are three main study visits where participants will complete assessments about their sleep mood cognition and health These would be
Before the therapy program begins
Right after it ends
Six months later
Around the time of each visit researchers will ask participants to wear an actigraphy watch on their wrist 247 for a week while completing a sleep diary The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participants activity and sleep levels
After the first main visit is complete participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks 8 sessions total Both groups will receive educational information and depending on the group the participants are assigned to may include guided discussions activities andor support addressing any stressors participants face sleep problems andor depression
During the therapy period researchers would ask participants to continue wearing the actigraphy watch Researchers would also ask participants to answer questions on the phone with study staff weekly that would take about 30-40 minutes a week
After the participants last therapy session researchers would repeat the phone assessments once a month until the last main visit occurs six-months after therapy ends
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None