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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162624
• Other study ID #: 2023-1590
• Secondary ID: Protocol Version
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Madilyn Michels
• Phone: 920-602-5612
• Email: mgmichels[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Specific Aims of the proposed study correspond directly to the three-step process. 1. In Step 1 (Specific Aim #1), we will 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), we will 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 one week 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Are able and willing participate.

Exclusion Criteria:

• Unable to provide informed consent
• Active self-harm or suicidal intent
• Scheduled transfer or release within three months

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

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.
• Cognitive Behavioral Therapy (CBT)
As control condition, CBT book "Feeling Good Self-Help Book" will be used

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligible participants	Feasibility will be assessed by measuring eligibility - percentage of individuals who meet inclusion criteria versus percentage of individuals who are excluded.	Study duration, up to 1 year
Primary	Participants who choose to participate	Feasibility will be assessed by measuring the percentage of eligible individuals who choose to participate in the study.	Study duration, up to 1 year
Primary	Percentage of participants that complete all 8 weeks	Feasibility will be assessed by measuring the percentage of participants who complete all treatment activities	Study duration, up to 1 year
Primary	Qualitative Summary of Reasons for Attrition	Feasibility will be assessed qualitatively by asking participants who leave the study, why they decided to stop. Responses will be coded for themes and summarized with participant counts.	Study duration, up to 1 year
Primary	Number of Participants referred for Follow up care	Safety will be measured through participant self-report suicidal or self-harm ideation, using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a questionnaire designed to assess the level of risk for self-harm. Any participant that indicates active suicidal ideation with intent to act or active suicidal ideation with a specific plan on the C-SSRS will be referred for follow up care.	Up to 13 weeks
Primary	Participant Satisfaction	Acceptability of the method will be assessed through Client Satisfaction Questionnaire (CSQ-8), which is an 8 item survey with potential scores of 8-32 with higher scores indicating greater satisfaction.	Up to 13 weeks
Primary	Change in Mental Health: Flexibility	The Multidimensional Psychological Flexibility Inventory (MPFI) assesses the 12 dimensions of flexibility and inflexibility. Responses have point values from 1 to 6, where higher scores reflect higher levels of the dimension being assessed by each set of items.	Baseline to 13 weeks
Primary	Change in Mental Health: Automatic Thoughts	The Automatic Thoughts Questionnaire lists are a variety of thoughts that pop into people's heads. Participants read each thought and indicate how frequently, if at all, the thought has occurred over the past week. 30 questions with a scale of 1-5, with 1 = not at all and 5 = all of the time. Higher scores indicate higher frequency of automatic thoughts.	Baseline to 13 weeks
Primary	Change in BAI Score	Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".	Baseline to 13 weeks
Primary	Change BDI-II Score	Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.	Baseline to 13 weeks