Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance and Commitment Therapy (ACT), Reflective Journaling.
- Who it may be relevant to
- Registry conditions: Anxiety, Depression, Depression, Anxiety, Anxiety Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 Reflective Journaling
As control condition, reflective journaling will be used.
Primary outcome measures
- Eligible participants [Time frame: Study duration, up to 1 year]
- Participants who choose to participate [Time frame: Study duration, up to 1 year]
- Percentage of participants that complete all 8 weeks [Time frame: Study duration, up to 1 year]
- Qualitative Summary of Reasons for Attrition [Time frame: Study duration, up to 1 year]
- Number of Participants referred for Follow up care [Time frame: Up to 13 weeks]
- Participant Satisfaction [Time frame: Up to 13 weeks]
- Change in Mental Health: Flexibility [Time frame: Baseline to 13 weeks]
- Change in Mental Health: Automatic Thoughts [Time frame: Baseline to 13 weeks]
- Change in BAI Score [Time frame: Baseline to 13 weeks]
- Change BDI-II Score [Time frame: Baseline to 13 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT06162624 · 2023-1590 · 1R34MH132663-01A1 · Protocol Version 4/13/26 · A538900 · SMPH/PSYCHIATRY/PSYCHIATRY