Cognitive Behavioral Therapy for Depression

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Active suicidality, Untreated bipolar, Psychosis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of cognitive behavioral therapy (CBT) for individuals with various mental health issues, particularly depression, at Massachusetts General Hospital. It involves two groups: one receiving CBT alone and another combining CBT with behavioral medicine to address both mental and general health concerns. Individuals with conditions like depression, anxiety, or obsessive-compulsive disorder who wish to change certain behaviors or mood patterns may be suitable candidates. Participants should be able to complete questionnaires and have a primary care provider at MGH. As an unphased study, this trial provides a unique opportunity to explore innovative therapy combinations that could enhance mental and general health.

Do I need to stop my current medications for this trial?

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

What prior data suggests that cognitive behavioral therapy is safe for treating depression?

Research shows that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. It helps individuals change unhelpful thoughts and behaviors. CBT has been successfully used for various mental health issues, such as depression and anxiety. Most participants continue with CBT, as an average dropout rate of 21% in various studies indicates that most find it manageable.

The version called Behavioral Medicine with Cognitive Behavioral Therapy focuses on similar goals, combining mental health techniques with general health advice. Studies support that CBT is safe for conditions like insomnia and depression. Therefore, both types of CBT in this trial appear safe based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for treating depression because it offers a unique approach compared to traditional treatments like antidepressant medications. Unlike medications that primarily alter brain chemistry, CBT focuses on changing thought patterns and behaviors that contribute to depression, empowering patients with practical skills to manage their mental health. Additionally, the trial explores a fresh angle by incorporating behavioral medicine alongside CBT to address both mental and general health concerns, offering a more holistic treatment approach. This dual focus has the potential to improve overall well-being, making it an appealing option for those seeking comprehensive care.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for depression?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively treats depression. A review of 115 studies found CBT to be a strong treatment option, with benefits comparable to or even surpassing medication over time. Another study found that CBT significantly reduced depression, as measured by common assessment tools. CBT helps individuals change negative thought patterns, improving mood and behavior. Both in-person and online CBT have proven effective for major depression. Overall, CBT is a well-supported choice for managing depression symptoms. Participants in this trial may receive CBT alone or as part of a Behavioral Medicine approach that includes CBT, focusing on both general health and mental health concerns. ^{2 6 7 8 9}

Who Is on the Research Team?

Sabine Wilhelm, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults over 18 who can consent and follow study procedures, with conditions like anxiety, depression, ADHD, eating disorders, PTSD, OCD or chronic medical concerns. They must be patients or employees at MGH. Excluded if they have mental retardation, psychosis, recent CBT treatment for the same issue or are actively suicidal.

Inclusion Criteria

I have a medical condition or concern, with or without a mental health disorder, and need help changing my health behaviors.

I have anxiety, depression, PTSD, ADHD, or an eating disorder.

Ability to provide informed consent and comply with the study procedures

Exclusion Criteria

Psychosis

Mental retardation

Exhibit active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy interventions provided by unlicensed professionals

24 weeks

24 visits (in-person), 1 visit per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy (CBT)

Trial Overview The trial is testing how well cognitive behavioral therapy (CBT) works when provided by unlicensed professionals to treat a variety of mental health and behavioral issues at Massachusetts General Hospital.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Group II: Behavioral Medicine with Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Participants enrolled in this arm of this study will be treated by the behavioral medicine interns with cognitive behavioral therapy focused on both their general health concerns and mental health concerns.

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840507/

Cognitive behavior therapy vs. control conditions, other ... CBT appears to be as effective as pharmacotherapies at the short term, but more effective at the longer term. Keywords: Depression, cognitive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7001356/

Cognitive Behavioral Therapy for Depression - PMC A meta-analysis of 115 studies has shown that CBT is an effective treatment strategy for depression and combined treatment with pharmacotherapy is ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788926

Effect of Computer-Assisted Cognitive Behavior Therapy vs ... In this randomized clinical trial of 175 adults, CCBT reduced depression, as measured by the Patient Health Questionnaire–9, to a significantly greater extent ...

4. nature.com nature.com/articles/s41746-022-00677-8

A systematic review of digital and face-to-face cognitive ... Face-to-face and digital CBT are effective therapy approaches for the treatment of major depression. While currently available evidence suggests ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... Within CBTs for depression specifically, a systematic review and meta-analysis showed that lower age, higher initial depression severity, individual treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7378630/

The Clinical Effectiveness of Cognitive Behavioral Therapy ... Currently, findings support that CBT-I seems to be effective and safe for insomnia comorbid with depression to improve the insomnia condition.

8. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/article-abstract/2832696

Cognitive Behavior Therapy for Mental Disorders in Adults In this unified series of meta-analyses, CBT was probably effective in the treatment of mental disorders, including major depression, anxiety disorders, PTSD, ...

9. mdpi.com mdpi.com/1648-9144/61/3/431

Next-Generation Cognitive-Behavioral Therapy for ... Cognitive-behavioral therapy (CBT) is a well-established and effective treatment for depression. However, traditional CBT faces limitations that may restrict ...