ACT Self-help Workbook for Depression and Anxiety

Overseen By Talia Cohen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Self-harm, Suicidal intent, Transfer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a self-help workbook designed for individuals dealing with anxiety and depression. The goal is to determine if this workbook can effectively help individuals manage their symptoms in a prison setting. Participants will use either the new ACT (Acceptance and Commitment Therapy) workbook or a control workbook over a 13-week period. This trial suits those currently in prison who experience moderate to severe anxiety or depression and have no plans for transfer or release in the next three months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental health resources in prisons.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this workbook is safe for use in a prison setting?

Research has shown that more than one in ten people using Acceptance and Commitment Therapy (ACT) self-help workbooks might experience unwanted effects, such as negative feelings or reactions. However, these workbooks have shown promise in helping with stress, anxiety, and depression.

Overall, ACT workbooks are considered safe for most people. They address various mental health issues and are generally well-tolerated. Those with concerns about these effects should consult the researchers or a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT (Acceptance and Commitment Therapy) Self-help Workbook because it offers a unique and accessible approach to treating depression and anxiety. Unlike traditional medication or in-person therapy sessions, this workbook empowers individuals to actively engage with therapeutic concepts at their own pace, which can be particularly appealing for those seeking a more flexible and self-guided method. The workbook focuses on helping users build psychological flexibility and mindfulness, which are key components of ACT, providing a novel way to address mental health issues by encouraging acceptance and action in alignment with personal values. This approach is different from many existing treatments that may focus more on symptom reduction rather than holistic personal growth and value-driven living.

What evidence suggests that the ACT Self-help Workbook is effective for depression and anxiety?

Research shows that self-help workbooks based on ACT (Acceptance and Commitment Therapy) can reduce symptoms of depression and anxiety. In earlier studies, people using these workbooks reported feeling less depressed, anxious, and stressed. For instance, one small study found that many participants felt better after using them. This trial will compare the ACT Self-help Workbook, which participants may receive, with a Control workbook. These workbooks provide clear guidance to help people manage their mental health more effectively. While most research focuses on people outside of prison, these workbooks might also benefit those in different settings, such as prisons. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Koenigs, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults in prison with moderate to severe anxiety or depression, who can read at a 6th-grade level or higher and have no plans of transfer or release within three months. Participants must not be actively self-harming or suicidal.

Inclusion Criteria

You are not currently trying to hurt yourself or have thoughts of wanting to hurt yourself.

I have moderate to severe anxiety or depression according to the BDI-II and BAI tests.

I am willing and able to participate in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Assessment

Participants complete a Pre-Treatment Assessment prior to distribution of the workbook

1 week

1 visit (in-person)

Treatment

Participants complete one chapter of the ACT self-help workbook per week

8 weeks

Weekly self-guided workbook completion

Mid-Treatment Assessment

Participants complete a Mid-Treatment Assessment four weeks after the distribution of the workbook

1 week

1 visit (in-person)

Post-Treatment Assessment #1

Participants complete a Post-Treatment Assessment eight weeks after distribution of the workbook

1 week

1 visit (in-person)

Focus Group

Participants engage in a focus group after completion of the workbook

1 week

1 visit (in-person)

Post-Treatment Assessment #2

Participants complete a Post-Treatment Assessment twelve weeks after distribution of the workbook

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACT Self-help Workbook

Trial Overview

The study tests an Acceptance and Commitment Therapy (ACT) workbook adapted for prisoners against Cognitive Behavioral Therapy (CBT). It aims to see how feasible, acceptable, and effective the ACT approach is over a period of 13 weeks.

How Is the Trial Designed?

Group I: ACT workbook Experimental Treatment 1 Intervention

Group II: Control workbook Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A meta-analysis of 21 studies involving 810 participants found that guided self-help for depression and anxiety is as effective as face-to-face psychotherapy, with an overall effect size of d=-0.02, slightly favoring guided self-help.

Both treatment formats showed similar drop-out rates, suggesting that guided self-help is a safe and viable alternative to traditional therapy, warranting consideration for routine care implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Cuijpers, P., Donker, T., van Straten, A., et al.[2022]

In a study of 536 individuals not actively seeking treatment for depression, psychotherapy and guided self-help were rated as the most acceptable and preferred treatment options, while antidepressants and bibliotherapy were considered the least acceptable.

Participants perceived antidepressants as likely to have side effects, which influenced their preferences, indicating a need for further research into why unguided self-help methods are less favored compared to guided approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Preferences towards Self-help Treatments for Depression in Comparison to Psychotherapy and Antidepressant Medication. Hanson, K., Webb, TL., Sheeran, P., et al.[2016]

A quality improvement strategy using systematic patient feedback (PCOMS) in an inpatient psychiatric facility with 2,247 patients led to significant improvements in treatment outcomes, with effect sizes comparable to randomized clinical trials for depression.

The readmission rates for patients were notably lower than national benchmarks, at 6.1% within 30 days, indicating that focusing on patient-centered care and real-time feedback may help reduce psychiatric readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient feedback as a quality improvement strategy in an acute care, inpatient unit: An investigation of outcome and readmission rates. Reese, RJ., Duncan, BL., Kodet, J., et al.[2019]

Structured self-help materials can effectively address common mental disorders like depression, providing an accessible alternative to traditional psychotherapy, especially when specialist services are limited.

These self-help resources not only aim to improve mental health but also focus on educating patients, enhancing their self-management skills, which can increase the credibility and effectiveness of these treatments in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written and computer-based self-help treatments for depression. Williams, C., Whitfield, G.[2022]

A quality improvement project involving 124 psychiatric patients showed that individualized safety plans created during inpatient treatment were well-tailored, scoring an average of 32.85 out of 44 on a customization rubric.

Postdischarge, 96.1% of patients retained their safety plans, and 36.8% reported using them, with 67.9% of those users finding the plans helpful, indicating that these plans can support recovery after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. Leonard, J., Chiappetta, L., Stark, S., et al.[2023]

Clinicians who utilized outcome reports from a managed behavioral healthcare organization saw greater patient improvement over 6 months, indicating that monitoring progress can enhance treatment effectiveness.

Patients whose clinicians actively read and applied outcome measures in their practice experienced the most significant improvements, suggesting that ongoing assessment is crucial for optimizing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring patient improvement and treatment outcomes in managed behavioral health. Azocar, F., Cuffel, B., McCulloch, J., et al.[2019]

A study involving 503 participants evaluated the effectiveness of an Acceptance and Commitment Therapy (ACT) self-help workbook for anxiety, showing significant improvements in anxiety symptoms and quality of life after 12 weeks compared to a wait-list group.

The benefits of the workbook were maintained at follow-up assessments, suggesting that ACT-based self-help could be a promising and low-cost intervention for individuals with anxiety, even without therapist contact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of ACT for Anxiety Disorders in a Self-Help Context: Outcomes From a Randomized Wait-List Controlled Trial. Ritzert, TR., Forsyth, JP., Sheppard, SC., et al.[2018]

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

A self-help workbook intervention for cancer patients undergoing chemotherapy did not significantly improve overall quality of life (QOL) or survival rates, based on a randomized controlled trial with 200 participants.

However, among patients who continued chemotherapy for 24 weeks, the workbook was associated with a significant improvement in emotional functioning, suggesting it may help with emotional distress during long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial. Takano, T., Matsuda, A., Ishizuka, N., et al.[2021]

A depression self-care intervention involving trained lay coaching and cognitive-behavioral therapy (CBT) tools significantly improved depression outcomes in patients with chronic physical conditions, as shown in a study of 275 participants across three studies.

However, this intervention did not yield the same benefits for cancer survivors, indicating that the effectiveness of these components may vary based on the patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trained lay coaches and self-care cognitive-behavioral tools improve depression outcomes. McCusker, J., Lambert, SD., Ciampi, A., et al.[2022]

In a review of 142 randomized trials of mental health interventions, only 21.4% of drug trials adequately reported clinical adverse events, highlighting a significant gap in safety information.

None of the trials for non-drug interventions provided adequate safety reporting, which complicates the evaluation of risks versus benefits in mental health treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety reporting in randomized trials of mental health interventions. Papanikolaou, PN., Churchill, R., Wahlbeck, K., et al.[2022]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

A study involving 1,326 adults with sub-threshold depression found that self-help strategies rated as most helpful by experts, like exercise, were also perceived as effective by users, indicating a potential benefit of these strategies.

However, there was little correlation between the perceived helpfulness of a strategy and its frequency of use, suggesting that many individuals may not be using the most effective self-help methods available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usage and reported helpfulness of self-help strategies by adults with sub-threshold depression. Morgan, AJ., Jorm, AF., Mackinnon, AJ.[2018]

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

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