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

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To examine the effectiveness and clinical care outcomes of cognitive-behavioral therapy interventions at Massachusetts General Hospital (MGH).

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+