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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH132663-01A1 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 4/13/26 | Other Identifier | UW Madison | |
| A538900 | Other Identifier | UW Madison | |
| SMPH/PSYCHIATRY/PSYCHIATRY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
The Specific Aims of the proposed study correspond directly to the three-step process.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT workbook | Experimental |
| |
| Control workbook | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madilyn Michels | Contact | 920-602-5612 | mgmichels@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Koenigs, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Reflective Journaling | Behavioral | As control condition, reflective journaling will be used. |
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| 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 |