Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
Purpose
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.
Conditions
- Anxiety
- Depression
- Depression, Anxiety
- Anxiety Disorders
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years of age or older - Reading level of 6th grade or higher determined by the Wide Range Achievement Test - Moderate or severe anxiety and/or depression determined by the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) - No active self-harm or active suicidal intent - No scheduled transfer or release for at least three months - Must be willing and able to participate, including having permission and ability to use study materials, such as paper and a writing utensil
Exclusion Criteria
- Unable to provide informed consent - Active self-harm or suicidal intent - Scheduled transfer or release within three months
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ACT workbook |
|
|
|
Active Comparator Control workbook |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Wisconsin, Madison
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.
