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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Schwartz Outcome Scale (SOS-10)
Side effects data
From 2008 Phase 3 trial • 150 Patients • NCT0007480269%
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%
Photophobia
14%
Diarrhea
14%
Blurry Vision
14%
Vomiting
10%
Parathesias
10%
Impaired Coordination
7%
Bradycardia
3%
Heavy menstrual bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paroxetine Continuation
Paroxetine With CBT Augmentation
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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,941 Previous Clinical Trials
13,200,419 Total Patients Enrolled
185 Trials studying Depression
29,393 Patients Enrolled for Depression
Sabine Wilhelm, PhDPrincipal InvestigatorMassachusetts General Hospital
12 Previous Clinical Trials
671 Total Patients Enrolled
2 Trials studying Depression
112 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a medical condition or concern, with or without a mental health disorder, and need help changing my health behaviors.Patients seeking help at the Behavioral Medicine Service have medical or health-related concerns, and may or may not have a specific psychiatric disorder. Patients seeking treatment at the OCD program typically have conditions such as obsessive compulsive disorder, body dysmorphic disorder, Tourette syndrome, compulsive skin picking, or trichotillomania. Patients seeking treatment at the general CBT program typically have conditions like panic disorder, social phobia, generalized anxiety disorder, depression, specific phobia, post traumatic stress disorder, attention deficit hyperactivity disorder, or an eating disorder. All patients seeking treatment have a behavior or mood issue they want to change.I have a condition that makes me unable to undergo cognitive behavioral therapy.I am 18 years old or older.I have anxiety, depression, PTSD, ADHD, or an eating disorder.I have a medical condition or concern, with or without a mental health disorder, and need help with changing my health behaviors.I have had over 4 CBT sessions for my condition in the last 3 years.I want to change a specific behavior or mood problem.I have OCD, body dysmorphic disorder, Tourette syndrome, compulsive skin picking, or trichotillomania.I have a mental health condition like anxiety, depression, PTSD, ADHD, or an eating disorder.I want to change a specific behavior or mood problem.I have OCD, body dysmorphic disorder, Tourette syndrome, skin picking, or trichotillomania.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy
- Group 2: Behavioral Medicine with Cognitive Behavioral Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this clinical trial?
"Per clinicaltrials.gov, this research study is not presently recruiting individuals; it was initially posted on January 1st 2010 and its last update occurred on April 12th 2022. Although no longer looking for test subjects at this juncture, there are 2,749 other studies actively seeking out participants."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Cognitive-Behavioral Therapy and Behavioral Medicine Programs, Massachusetts General Hospital
Why did patients apply to this trial?
Other Trials to Consider
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