Clinical trial NCT06162624: Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
Official title: Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Depression, Anxiety
Anxiety Disorders
Keywords: incarcerated
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-12-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Eligible participants
timeFrame: Study duration, up to 1 year
measure: Participants who choose to participate
timeFrame: Study duration, up to 1 year
measure: Percentage of participants that complete all 8 weeks
timeFrame: Study duration, up to 1 year
measure: Qualitative Summary of Reasons for Attrition
timeFrame: Study duration, up to 1 year
measure: Number of Participants referred for Follow up care
timeFrame: Up to 13 weeks
measure: Participant Satisfaction
timeFrame: Up to 13 weeks
measure: Change in Mental Health: Flexibility
timeFrame: Baseline to 13 weeks
measure: Change in Mental Health: Automatic Thoughts
timeFrame: Baseline to 13 weeks
measure: Change in BAI Score
timeFrame: Baseline to 13 weeks
measure: Change BDI-II Score
timeFrame: Baseline to 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Koenigs, PhD
role: PRINCIPAL_INVESTIGATOR
References: