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Behavioral Intervention

Cognitive Behavioral Therapy for Depression

N/A

Waitlist Available

Led By Sabine Wilhelm, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Age 18 or older

Be older than 18 years old

Must not have

Received more than 4 sessions of CBT for the target disorder within the past 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether cognitive-behavioral therapy can improve clinical care outcomes at MGH.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

CBT is generally safe but may cause temporary discomfort as individuals confront and work through difficult emotions and behaviors during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had over 4 CBT sessions for my condition in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, and at visits 1 through 24, which will occur approximately 1 week apart.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, and at visits 1 through 24, which will occur approximately 1 week apart. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The Schwartz Outcome Scale (SOS-10)

Side effects data

From 2008 Phase 3 trial • 150 Patients • NCT00074802

69%

Anorgasmia

66%

Weight Gain

55%

Decreased Libido

55%

Somnolence

52%

Constipation

52%

Lightheadedness

48%

Nervousness

48%

Fatigue

45%

Dry Mouth

41%

Sweating

38%

Nausea

38%

Headache

34%

Palpitations

34%

Myalgia

34%

Insomnia

28%

Tachycardia

24%

Nasal Congestion

24%

Rigidity

21%

Dermatitis

21%

Urinary Congestion

17%

Weight Loss

17%

Tremor

14%

Vomiting

14%

Photophobia

14%

Diarrhea

14%

Blurry Vision

10%

Parathesias

10%

Impaired Coordination

Bradycardia

Heavy menstrual bleeding

100%

80%

60%

40%

20%

Study treatment Arm

Paroxetine Continuation

Paroxetine With CBT Augmentation

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

Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention

Group II: Behavioral Medicine with Cognitive Behavioral TherapyExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive behavioral therapy (CBT)

2002

Completed Phase 3

~2020

0 / 2Eligibility criteria met