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

University of Wisconsin (UW)

Status: Enrolling

Conditions: Depression, Anxiety; Depression; Anxiety Disorders; Anxiety

Treatments: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06162624

A538900 (Other Identifier)

2023-1590

Protocol Version 07/02/25 (Other Identifier)

1R34MH132663-01A1 (U.S. NIH Grant/Contract)

SMPH/PSYCHIATRY/PSYCHIATRY (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

96 participants in 2 patient groups

ACT workbook

Experimental group

Treatment:

Behavioral: Acceptance and Commitment Therapy (ACT)

Control workbook

Active Comparator group

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)