What side effects are associated with this type of intervention?

Common treatments for depression, such as cognitive-behavioral therapy (CBT) and its adaptations like Adapted Cognitive-Behavior Therapy (ACBT), generally have fewer side effects compared to medications. However, patients may experience increased anxiety or emotional discomfort as they confront distressing thoughts and behaviors during therapy. The process can also be time-consuming and emotionally demanding. Adaptations like ACBT aim to make therapy more accessible and easier to understand, potentially reducing these challenges.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and atypical antidepressants like bupropion. While these medications are commonly used, cognitive-behavioral therapy (CBT) is a well-established non-pharmacological treatment for depression. Adapted Cognitive-Behavior Therapy (ACBT) is a novel form of CBT designed to be more accessible for individuals with low literacy. Although ACBT itself is not yet FDA-approved, it builds on the principles of standard CBT, which is widely recognized and recommended in clinical guidelines for the treatment of depression.

What other types of research exist?

Promising, novel alternatives to Adapted Cognitive-Behavior Therapy (ACBT) for depression patients include: 1) Internet-based Cognitive Behavioral Therapy (ICBT), which combines CBT with Positive Psychology strategies and is designed to be user-friendly and accessible. 2) Digital Cognitive Behavioral Therapy (dCBT), which has shown improvements in health, psychological well-being, and sleep-related quality of life. 3) Brief Behavioral Therapy (BBT), which has demonstrated efficacy in improving mood and cognitive outcomes in older adults. These alternatives leverage technology and simplified approaches to make therapy more accessible and effective for individuals with low literacy.

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Cognitive Behavioral Therapy for Depression (CBT Trial)

N/A

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new, easier-to-understand therapy called Adapted Cognitive-Behavior Therapy (ACBT) for women with depression who have trouble reading. The goal is to see if ACBT works better than regular therapy for these women.

Who is the study for?

This trial is for English-speaking women over 18 with major depressive disorder who are willing to try different types of therapy and complete all study assessments. They must not plan to move from the Chicagoland area during the study, have no severe substance use disorders, suicidal actions in recent months, or significant neurological diseases.

What is being tested?

The trial compares Adapted Cognitive-Behavior Therapy (ACBT), designed for those with low literacy, against standard Cognitive Behavior Therapy (CBT) to see which is more effective at improving outcomes for women suffering from depression.

What are the potential side effects?

While CBT typically doesn't cause physical side effects, participants may experience emotional discomfort discussing personal issues. Some might feel anxious or upset temporarily after sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment which is within 2 weeks after final therapy session (i.e. estimated 12-14 weeks after initial intake interview) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PROMIS Depression: : 3-month follow-up (defined as 3 months after the last (i.e., 12th) session of cognitive behavior therapy.

PROMIS Depression: Post-treatment (defined as completing 12 therapy session)

Secondary study objectives

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): 3-month follow-up (defined as 3 months after the end of treatment)

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0): Post-treatment (defined as completing 12 sessions of therapy; this will occur an estimated 12-14 weeks after initial intake interview)

Other study objectives

California Psychotherapy Alliance Scale - Participant version short-form - Post-treatment (defined as completing 12 sessions of therapy; this will occur an estimated 12-14 weeks after initial intake interview)

Patient Global Impression of Change (PGIC) 3-month follow-up (defined as 3 months after the end of treatment)

Patient Global Impression of Change (PGIC): Post-treatment (defined as completing 12 sessions of therapy; this will occur an estimated 12-14 weeks after initial intake interview)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adapted CBTExperimental Treatment1 Intervention

Adapted CBT, 12 sessions each lasting 45 minutes

Group II: Standard CBTActive Control1 Intervention

Standard CBT, 12 sessions each lasting 45 minutes

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adapted CBT

2020

N/A

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-Behavioral Therapy (CBT) helps depression patients by identifying and modifying negative thought patterns and behaviors. Adapted Cognitive-Behavior Therapy (ACBT) tailors this approach for individuals with low literacy, using simpler language and methods to ensure better understanding and engagement. This inclusivity is crucial as it makes effective treatment accessible to a broader range of patients, potentially improving their outcomes.