NCT06162624

Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anxiety
• Depression
• Depression, Anxiety
• Anxiety Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy (ACT)	ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Delivered over 8 weeks of self-guided study and homework assignments.
BEHAVIORAL	Cognitive Behavioral Therapy (CBT)	As control condition, reflective journaling will be used.

Timeline

• Start date: 2024-12-09
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-12-08
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States