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

Study Overview
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Brief Summary
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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
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The Specific Aims of the proposed study correspond directly to the three-step process. 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. In Step 2 (Specific Aim #2), we will refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook. 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.

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

Conditions
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Anxiety, Depression, Depression, Anxiety, Anxiety Disorders

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy (ACT)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT workbook<br> | Behavioral: Acceptance and Commitment Therapy (ACT)<br>* 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.<br>|
| Active Comparator: Control workbook<br> | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* As control condition, CBT book Feeling Good Self-Help Book will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Reasons for attrition | Feasibility will be assessed qualitatively by asking participants who leave the study, why they decided to stop. | Study duration, up to 1 year | 
| Safety: Self-harm | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incarcerated