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

NCT06162624 | Recruiting DMC

• 5 other identifiers: 2023-15901R34MH132663-01A1Protocol Version 4/13/26A538900SMPH/PSYCHIATRY/PSYCHIATRY
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depression, Anxiety; Anxiety Disorders; Anxiety

Keywords

incarcerated

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

ACT workbook

EXPERIMENTAL

Behavioral: Acceptance and Commitment Therapy (ACT)

Control workbook

ACTIVE COMPARATOR

Behavioral: Reflective Journaling

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

ACT workbook

Reflective Journaling BEHAVIORAL

As control condition, reflective journaling will be used.

Control workbook

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael Koenigs, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madilyn Michels

CONTACT

920-602-5612; mgmichels@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: December 9, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)