ACT Self-help Workbook for Depression and Anxiety

Overseen By Talia Cohen

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Self-harm, Suicidal intent, Transfer

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the ACT Self-help Workbook treatment for depression and anxiety?

Research shows that self-help workbooks can be effective for mental health conditions like depression, as they provide structured guidance to help people manage their symptoms. These materials are designed to improve knowledge and self-management skills, making them a useful tool for those who may not have easy access to specialist therapy. ^{1 2 3 4 5}

Is the ACT Self-help Workbook for Depression and Anxiety generally safe for humans?

Research on psychotherapy, including self-help workbooks, shows that adverse events (unwanted effects) can occur in more than one in ten participants, but serious adverse events are less common. The way these events are recorded and reported varies, so it's important to monitor and report any negative effects during treatment. ^{6 7 8 9 10}

How is the ACT Self-help Workbook treatment for depression and anxiety different from other treatments?

The ACT Self-help Workbook is unique because it allows individuals to manage their depression and anxiety without therapist contact, using a self-guided approach based on Acceptance and Commitment Therapy (ACT), which focuses on increasing psychological flexibility. This makes it a low-cost and accessible option compared to traditional face-to-face therapy. ^{11 12 13 14 15}

Research Team

Michael Koenigs, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• ACT Self-help Workbook (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Written and computer-based self-help treatments for depression. [2022]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Monitoring patient improvement and treatment outcomes in managed behavioral health. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Safety reporting in randomized trials of mental health interventions. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

11. England 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. [2018]

12. England 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. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Usage and reported helpfulness of self-help strategies by adults with sub-threshold depression. [2018]

14. Ireland pubmed.ncbi.nlm.nih.gov

Trained lay coaches and self-care cognitive-behavioral tools improve depression outcomes. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Attitudes and Preferences towards Self-help Treatments for Depression in Comparison to Psychotherapy and Antidepressant Medication. [2016]