Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162624
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-30
Brief Title:
Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability and effectiveness of this workbook
Participants can expect to be in the study for 13 weeks
Participants can expect to be in the study for 13 weeks
Detailed Description:
The Specific Aims of the proposed study correspond directly to the three-step process
1 In Step 1 Specific Aim 1 identify the necessary adaptations to the content language and format of an ACT-based self-help workbook through stakeholder input
2 In Step 2 Specific Aim 2 refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook
3 In Step 3 Specific Aim 3 determine the feasibility acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting Primary clinical outcome measure will be depression secondary clinical outcome measure will be anxiety
For each participant assigned to a condition a study team member will meet with them individually to provide them with a copy of the workbook During this meeting the study team member will inform the participant that they should complete one chapter per week
Participants will complete a Pre-Treatment Assessment prior to distribution of the workbook a Mid-Treatment Assessment four weeks after the distribution of the workbook a Post-Treatment Assessment 1 eight weeks after distribution of the workbook when the workbook should be completed Focus group after completion of workbook and a Post-Treatment Assessment 2 twelve weeks after distribution of the workbook
1 In Step 1 Specific Aim 1 identify the necessary adaptations to the content language and format of an ACT-based self-help workbook through stakeholder input
2 In Step 2 Specific Aim 2 refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook
3 In Step 3 Specific Aim 3 determine the feasibility acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting Primary clinical outcome measure will be depression secondary clinical outcome measure will be anxiety
For each participant assigned to a condition a study team member will meet with them individually to provide them with a copy of the workbook During this meeting the study team member will inform the participant that they should complete one chapter per week
Participants will complete a Pre-Treatment Assessment prior to distribution of the workbook a Mid-Treatment Assessment four weeks after the distribution of the workbook a Post-Treatment Assessment 1 eight weeks after distribution of the workbook when the workbook should be completed Focus group after completion of workbook and a Post-Treatment Assessment 2 twelve weeks after distribution of the workbook
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 |
|---|---|---|---|
| 1R34MH132663-01A1 | NIH | UW Madison | httpsreporternihgovquickSearch1R34MH132663-01A1 |
| Protocol Version 1192023 | OTHER | None | None |
| A538900 | OTHER | None | None |
| SMPHPSYCHIATRYPSYCHIATRY | OTHER | None | None |