AnxietyNCT06162624
Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
A study testing Acceptance and Commitment Therapy (ACT) and Reflective Journaling in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Depression, Anxiety
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Reflective Journaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Active self-harm or suicidal intent
- Scheduled transfer or release within three months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Specific Aims of the proposed study correspond directly to the three-step process.
- In Phase 1 (Specific Aim #1), identify the necessary adaptations to the content, language, and format of an ACT-based self-help workbook through stakeholder input.
- In Phase 2 (Specific Aim #2), refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook.
- In Phase 3 (Specific Aim #3), determine the feasibility, acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting. This phase involved an RCT, comparing the ACT workbook to the Control workbook (reflective journal prompts). 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 recommend the participant should complete one chapter per week.
Participants will complete a pre-treatment assessment prior to distribution of the workbook, an assessment four weeks after the distribution of the workbook, an assessment eight weeks after distribution of the workbook, and an assessment twelve weeks after distribution of the workbook. After completion of the workbook, participants may also be invited to participate in a Focus group and/or a 1on1 interview with staff.
- Conditions
- Anxiety, Depression, Depression, Anxiety, Anxiety Disorders
- Being tested
- Acceptance and Commitment Therapy (ACT), Reflective Journaling
- Keywords
- incarcerated
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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.
Reflective JournalingBehavioural
As control condition, reflective journaling will be used.
| Study group | Role | What they receive |
|---|---|---|
| ACT workbook | Experimental | Acceptance and Commitment Therapy (ACT): ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Specifically, the experimental condition was an Acceptance and Commitment Therapy (ACT) self-help workbook tailored for prisons. Delivered over 8 weeks of self-guided study and homework assignments.
The ACT workbook consisted of 8 chapters during Phase 2 of the study and 9 chapters during Phase 3. Practices and exercises from both "Get Out of Your Mind and Into Your Life; The New Acceptance and Commitment Therapy," by Steven C. Hayes and Spencer Smith, and the Achieving Change Through Value-Based Behavior (ACTV) program, developed by Dr. Amie Zarling for group facilitation in Iowa prisons based on ACT, were adapted and incorporated by the research team to create this ACT workbook for the prison setting. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Control workbook | Active comparator | For the control condition during Phase 3, reflective journaling will be used. The journal prompts (7 total) are adapted from the expressive writing paradigm developed by James Pennebaker. Expressive writing involves writing about one's thoughts and feelings related to stressful or emotional experiences for a brief period across several sessions. The research team, including ACT Clinician Amie Zarling and two formerly incarcerated community partners worked to make the journal prompts more relevant to a prison setting. Receives: Behavioral: Reflective Journaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligible participants
Feasibility will be assessed by measuring eligibility - percentage of individuals who meet inclusion criteria versus percentage of individuals who are excluded.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Baseline to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start9 Dec 2024
- Primary completion29 Jun 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both Phase 2 and Phase 3 of this study involved human subjects research data collection. In Phase 2 (single arm), participants were only assigned to the ACT Workbook as part of the refinement process to gather feedback from the participants on the ACT Workbook in preparation for the RCT in Phase 3. In Phase 3 (RCT phase with 2 arms), participants were randomized to either the ACT Workbook condition or the Reflective Journaling condition.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael Koenigs, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162624
- Sponsor's protocol ID
- 2023-1590
- Other IDs
- 1R34MH132663-01A1, Protocol Version 4/13/26, A538900, SMPH/PSYCHIATRY/PSYCHIATRY
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons
- ClinicalTrials.gov ID
- NCT06162624
- Acronym / sponsor ID
- 2023-1590
- Conditions
- Anxiety, Depression, Depression, Anxiety, Anxiety Disorders
- Keywords
- incarcerated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- In Phase 1 (Specific Aim #1), identify the necessary adaptations to the content, language, and format of an ACT-based self-help workbook through stakeholder input.
- In Phase 2 (Specific Aim #2), refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook.
- In Phase 3 (Specific Aim #3), determine the feasibility, acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting. This phase involved an RCT, comparing the ACT workbook to the Control workbook (reflective journal prompts). 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 recommend the participant should complete one chapter per week.
Participants will complete a pre-treatment assessment prior to distribution of the workbook, an assessment four weeks after the distribution of the workbook, an assessment eight weeks after distribution of the workbook, and an assessment twelve weeks after distribution of the workbook. After completion of the workbook, participants may also be invited to participate in a Focus group and/or a 1on1 interview with staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Both Phase 2 and Phase 3 of this study involved human subjects research data collection. In Phase 2 (single arm), participants were only assigned to the ACT Workbook as part of the refinement process to gather feedback from the participants on the ACT Workbook in preparation for the RCT in Phase 3. In Phase 3 (RCT phase with 2 arms), participants were randomized to either the ACT Workbook condition or the Reflective Journaling condition.
| Arm | Type | Receives |
|---|---|---|
| ACT workbook | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)Acceptance and Commitment Therapy (ACT): ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Specifically, the experimental condition was an Acceptance and Commitment Therapy (ACT) self-help workbook tailored for prisons. Delivered over 8 weeks of self-guided study and homework assignments. The ACT workbook consisted of 8 chapters during Phase 2 of the study and 9 chapters during Phase 3. Practices and exercises from both "Get Out of Your Mind and Into Your Life; The New Acceptance and Commitment Therapy," by Steven C. Hayes and Spencer Smith, and the Achieving Change Through Value-Based Behavior (ACTV) program, developed by Dr. Amie Zarling for group facilitation in Iowa prisons based on ACT, were adapted and incorporated by the research team to create this ACT workbook for the prison setting. |
| Control workbook | Active comparator | Behavioral: Reflective JournalingFor the control condition during Phase 3, reflective journaling will be used. The journal prompts (7 total) are adapted from the expressive writing paradigm developed by James Pennebaker. Expressive writing involves writing about one's thoughts and feelings related to stressful or emotional experiences for a brief period across several sessions. The research team, including ACT Clinician Amie Zarling and two formerly incarcerated community partners worked to make the journal prompts more relevant to a prison setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Active self-harm or suicidal intent
- Scheduled transfer or release within three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT workbook |
| Reflective JournalingAs control condition, reflective journaling will be used. | Behavioural | Control workbook |
Primary outcome
Eligible participants
Time frame: Study duration, up to 1 year
Feasibility will be assessed by measuring eligibility - percentage of individuals who meet inclusion criteria versus percentage of individuals who are excluded.
Participants who choose to participate
Time frame: Study duration, up to 1 year
Feasibility will be assessed by measuring the percentage of eligible individuals who choose to participate in the study.
Percentage of participants that complete all 8 weeks
Time frame: Study duration, up to 1 year
Feasibility will be assessed by measuring the percentage of participants who complete all treatment activities
Qualitative Summary of Reasons for Attrition
Time frame: Study duration, up to 1 year
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.
Number of Participants referred for Follow up care
Time frame: Up to 13 weeks
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.
Participant Satisfaction
Time frame: Up to 13 weeks
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.
Change in Mental Health: Flexibility
Time frame: Baseline to 13 weeks
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.
Change in Mental Health: Automatic Thoughts
Time frame: Baseline to 13 weeks
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.
Change in BAI Score
Time frame: Baseline to 13 weeks
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".
Change BDI-II Score
Time frame: Baseline to 13 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Koenigs, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) and Reflective Journaling in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligible participants (time frame: Study duration, up to 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.